Import Alert 89-08

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 89-08
Published Date: 03/12/2024
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 03/13/2023 updates the reason for alert and guidance section. Changes to the import alert are bracketed by asterisks (***).

Devices listed on the Red List of this alert ***are either devices or which a 510(k) application has not been filled and/or determined substantially equivalent, Class III medical device for which there is no Pre-Market Approval (PMA) for commercial distribution, or investigational device that lacks an Investigational Device Exemption (IDE).***

Guidance:

Divisions may detain, without physical examination, shipments of the products identified on the Red List of this alert.

***Recommendations for addition to detention without physical examination under this import alert***, including analytical worksheets (if the product was analyzed), labeling, package inserts, user manuals, photographic evidence, website information, entry documents, etc., should be forwarded to the Division of Import Operations (DIO). DIO will coordinate a review of all recommendations with ***FDA's Center for Device and Radiological Health (CDRH) Imports and Registration & Listing Team (IRLT).***

Release of Articles Subject to Detention Without Physical Examination under this Import Alert:

In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party for the affected goods should provide a written application (Form FDA 766) requesting authorization to bring a device into compliance by relabeling or other action (reconditioning). ***Records should be submitted to the appropriate FDA Division compliance officer for consideration per the notice of detention.*** Divisions will refer such applications related to this alert to CDRH Imports and Registration & Listing Team, for concurrence.

For more information about reconditioning, please refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9, "9-12-Reconditioning."

For questions regarding device classification, please refer to the "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" guidance document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic

Removal from Detention Without Physical Examination under this Import Alert (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).

For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "9-8 Detention Without Physical Examination (DWPE)."

If a firm and/or representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations (DIO)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov

DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH Imports and Registration & Listing Team.

Questions or issues involving import operations, should be addressed to the Division of Import Operations at 301-796-0356, or email fdaimportsinquiry@fda.hhs.gov

Questions concerninvg these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: CDRH Import Mailbox cdrhimport@fda.hhs.gov

                                                                                                                                                                       

Product Description:

Medical Devices

Charge:

For Class III devices:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1). [Adulteration, Section 501(f)(1)(B)]

OASIS charge code: NO PMA

For other devices:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k) application does not appear to have been determined substantially equivalent or otherwise filed. [Misbranding, Section 502(o)]

OASIS charge code: NO 510(K)

Countries

MULTIPLE COUNTRIES

  • (79 K - - GM) Silicone, Liquid, Injectable

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


ARGENTINA


Lebian International S R L
Date Published : 05/16/2014
La Pax 1071 , Rosario, ARGENTINA
85 H - - -- Portion of device code
Date Published: 05/16/2014

Desc: Gynecological devices (Small #2; Medium #3; Large #4)
Notes: Autoexpandable and Discardable Speculum for Gynecological Use Models


ARMENIA


Dr Ashely Minas
Date Published : 06/24/2015
43 Moldovakan Str , Yerevan, ARMENIA
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 06/24/2015

Desc: Interfall Hydrogel Products
Notes: Class III. Interfall Hydrogel is a dermal filler marketed for; shaping the face; genitals; mammary glands and buttocks; elimination of deep deforming scars; and endoprosthetics of vocal cords in cases of paralytic stenosis of the larynx; as well as other purposes. Firm name could also be listed in records as Minasian Medical Centre and/or www.consultdrminas.com.

Dr. Ashley Minas
Date Published : 06/24/2015
No 31 Adranik Street , Meghri Town, Sunik ARMENIA
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 06/24/2015

Desc: Interfall Hydrogel Products
Notes: Class III. Interfall Hydrogel is a dermal filler marketed for; shaping the face; genitals; mammary glands and buttocks; elimination of deep deforming scars; and endoprosthetics of vocal cords in cases of paralytic stenosis of the larynx; as well as other purposes. Firm name could also be listed in records as Minasian Medical Centre and/or www.consultdrminas.com.


AUSTRALIA


AirPhysio Pty Ltd
Date Published : 10/16/2023
Suite A 13-17 Rivendell Drive , Tweed Heads South, New South Wales AUSTRALIA
73 B - - WF Spirometer, Therapeutic (Incentive)
Date Published: 10/16/2023

Desc: Better Breathing Sport

73 B - - WF Spirometer, Therapeutic (Incentive)
Date Published: 10/16/2023

Desc: Better Breathing Kids

73 B - - YI Percussor, Powered-Electric
Date Published: 10/16/2023

Desc: Better Breathing Sport

73 B - - YI Percussor, Powered-Electric
Date Published: 10/16/2023

Desc: Better Breathing Kids

Australian Light Therapy
Date Published : 09/16/2009
108 Forrest Street , Cottesloe, WA AUSTRALIA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. DE. Seasonal Affective Disorder Devices. (SAD Devices)

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Bionic Products Pty., Ltd.
Date Published : 12/20/2018
63 Manly Drive , Robina, Queensland AUSTRALIA
73 - - - -- Anesthesiology
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

74 - - - -- Cardiovascular
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

76 - - - -- Dental
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

77 - - - -- Ear,Nose And Throat
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

78 - - - -- Gastroenterological & Urological
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

79 - - - -- General & Plastic Surgery
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

80 - - - -- General Hospital/Personal Use
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

84 - - - -- Neurological
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

85 - - - -- Obstetrical & Gynecological
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

86 - - - -- Ophthalmic
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

87 - - - -- Orthopedic
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

89 - - - -- Physical Medicine
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

90 - - - -- Radiology
Date Published: 12/20/2018

Notes: Therapeutic Ionisers; Class III; 12/26/2002

Genetic Signatures Limited
Date Published : 01/21/2022
7 Eliza St , Newtown, New South Wales AUSTRALIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/21/2022

Desc: EasyScreen SARS-CoV-2 Detection Kit (RP011 & RP011-HT)

MELBOURNE BIOTECH
Date Published : 10/20/2020
5505 35 Queens Bridge Street , Southbank, Victoria AUSTRALIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/20/2020

Desc: MB COVID-19 Antibody Rapid Detection Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/20/2020

Desc: MB COVID-19 Antibody Rapid Detection Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/20/2020

Desc: MB COVID-19 Antibody Rapid Detection Test

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/20/2020

Desc: MB COVID-19 Antibody Rapid Detection Test

Medec Pty Ltd
Date Published : 09/16/2009
22 Letchworth Centre Ave , Salter, FN AUSTRALIA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/16/2009

Notes: MEDEC BioResonance System

PROMEDICAL EQUIPMENT PTY LTD
Date Published : 06/22/2020
5-22 Alexandra Pl , Murarrie, Queensland AUSTRALIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: COVID-19 Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: COVID-19 Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: COVID-19 Rapid Test

Planet Innovation Pty Ltd
Date Published : 08/31/2021
436 Elgar Rd , Box Hill, Victoria AUSTRALIA
75 J - - JQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Date Published: 08/31/2021

Desc: LIAISON IQ reader


BAHAMAS


IHT Ltd
Date Published : 09/16/2009
P.O. Box N4361 , Nassau, BAHAMAS
82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIV Oral Test (aka 1; 2 and Subtype O Saliva Test). 10/26/1999. Note HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827- 6201.

Newco Associates Limited
Date Published : 09/16/2009
P.O. Box CB12611 , Nassau, BAHAMAS
82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIV Oral Test (aka 1; 2 and Subtype O Saliva Test). 10/26/1999. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.


BELGIUM


Biocartis Nv
Date Published : 12/07/2021
B 3 , Generaal De Wittelaan 11 , Mechelen, Antwerp BELGIUM
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 12/07/2021

Desc: SeptiCyte RAPID

Coris Bioconcept
Date Published : 07/27/2021
Rue Jean Sonet 4a , Gemblouxgembloux, BELGIUM
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: CoV-2 Rapid Antigen Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: Covelex

MULTI-G BVBA
Date Published : 01/26/2021
Lange Leemstraat 166 , Antwerp, Antwerp BELGIUM
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: Multi-g COVID-19 IgG/IgM Rapid Test

ZenTech SA
Date Published : 03/02/2021
Avenue Pre-Aily 10 , Lige Science Park , Liege, Liege BELGIUM
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/02/2021

Desc: QuickZen COVID-19 IgM / IgG


BRITISH VIRGIN ISLANDS


Dynamax
Date Published : 06/20/2019
unknown , Unknown, BRITISH VIRGIN ISLANDS
76 - - - -- Dental
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

77 - - - -- Ear,Nose And Throat
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

87 - - - -- Orthopedic
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

Hadaco Ltd
Date Published : 06/20/2019
unknown , unknown, BRITISH VIRGIN ISLANDS
76 - - - -- Dental
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

77 - - - -- Ear,Nose And Throat
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

87 - - - -- Orthopedic
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

Tranquil Prospects
Date Published : 06/20/2019
unknown , Unkown, BRITISH VIRGIN ISLANDS
76 - - - -- Dental
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

77 - - - -- Ear,Nose And Throat
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

87 - - - -- Orthopedic
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

World Health Diagnostics, Inc.
Date Published : 09/16/2009
P.O. Box 362, Roadtown , Tortola, BRITISH VIRGIN ISLANDS
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 01/23/2019

Notes: HIV 2 Blood Test Kit. (aka HIV Testing Kit) HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201. 11/9/1999

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIV 2 Blood Test Kit. (aka HIV Testing Kit) HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201. 11/9/1999


CANADA


A & T Company
Date Published : 09/16/2009
43 Vanity Crest , Richmond Hill, ON CANADA
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: HIV 1/2 Saliva Test Kit (aka Easy Home Test or easyhivtest). 9/14/2000. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIV 1/2 Saliva Test Kit (aka Easy Home Test or easyhivtest). 9/14/2000. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Active Chi Enterprises Corp
Date Published : 07/21/2017
204-6910 No. 3 Rd , Richmond, British Columbia CANADA
84 H - - ST Apparatus, traction, non-powered
Date Published: 11/08/2018

Desc: Chisoft Neck Stretcher

Acumed Medical Supplies Ltd
Date Published : 03/08/2011
1 Director Crt Ste 102 , Woodbridge, ON CANADA
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: T.E.N.S. Pro 900 Energy Point Stimulator
Notes: Class III

Angel & Company
Date Published : 09/16/2009
P.O. Box 879 , Knowlton, QC CANADA
73 B - - ZQ Monitor, Breathing Frequency
Date Published: 09/16/2009

Notes: 12/15/1998 Angelcare sound & Breathing Frequency Monitor.

Anogen Division of Yes Biotech Lab
Date Published : 09/16/2009
7035 Fir Tree Drive , Mississauga, ON CANADA
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: HIV 1 & 2 ELISA. 7/10/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIV 1 & 2 ELISA. 7/10/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Anti Aging Solutions Inc.
Date Published : 09/16/2009
5-1 Westside Dr , Etobicoke, Ontario CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE. Revitalite Beautifying Soft Light Laser

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy
Date Published: 09/16/2009

Notes: 7/9/2004                         The canadian firm was issued a warning letter from CDRH on 3/25/2004; warning them to discontinue marketing these devices to the United States. There is currently no evidence that these devices are marketed in the US by the manufacturer. Districts should be aware that although he correct product code for this is 89NHN; the product has been mis-coded as 95L-22 (laser products/Laster product for non-medical use).

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Applied Biological Materials Inc
Date Published : 01/06/2022
1-3671 Viking Way , Richmond, British Columbia CANADA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/06/2022

Desc: GenomeCov19 Detection Kit

Aqua Sole Company Ltd
Date Published : 09/16/2009
27 Passmore Ave Unit #1 , Scarborough, ON CANADA
86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 09/16/2009

Notes: Eye Mask or Eye Masque.

Ark Bio Medical Canada Corp
Date Published : 10/07/2016
671 Rustico Rd - Rte 7 , North Milton, Prince Edward Island CANADA
81 K - - ZL Device, Warming, Blood and Plasma
Date Published: 10/07/2016

Desc: Ark Bio Microwave Plasma Defroster

Artron Laboratories, Inc.
Date Published : 06/23/2020
3938 North Fraser Way , Burnaby, British Columbia CANADA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/23/2020

Desc: COVID-19 IgM/IgG Antibody Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/23/2020

Desc: COVID-19 IgM/IgG Antibody Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 12/23/2020

Desc: OTO-Artron COVID-19 IgM/IgG Antibody Rapid Detection

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/07/2021

Desc: Artron COVID-19 Antigen Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/23/2020

Desc: COVID-19 IgM/IgG Antibody Test

Aurora Biomed, Inc.
Date Published : 07/07/2020
1001 Pender St E , Vancouver, British Columbia CANADA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/07/2020

Desc: COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/07/2020

Desc: COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/07/2020

Desc: COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)

BIOCAN DIAGNOSTICS INC
Date Published : 04/20/2021
55a & 53b Fawcett Road , Coquitlam, British Columbia CANADA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2021

Desc: Tell Me Fast

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2021

Desc: Tell Me Fast Novel Coronavirus (COVID19) IgG/IgM Antibody Test Strip

BIOLYTICAL LABORATORIES INC.
Date Published : 04/20/2022
406-13251 Delf Pl , Richmond, British Columbia CANADA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2022

Desc: INSTI COVID-19 Antibody Test

BIOLYTICAL LABORATORIES INC.
Date Published : 04/20/2022
1108-13351 Commerce Pky , Richmond, British Columbia CANADA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2022

Desc: INSTI COVID-19 Antibody Test

BLS Systems Ltd
Date Published : 01/14/2010
1124 South Service Rd W , Oakville, Ontario CANADA
73 C - - BP Valve, Non-Rebreathing
Date Published: 11/08/2023

Desc: Faceshield with one-way valve and filter

73 K - - GB Mask, Oxygen, Non-Rebreathing
Date Published: 01/14/2010

Desc: Faceshield with one-way valve and filter

BTNX Inc.
Date Published : 06/22/2021
722 Rosebank Rd , Pickering, Ontario CANADA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: Rapid Response COVID-19 Antigen Rapid Test Device

BTNX Inc.
Date Published : 06/22/2021
722 Rosebank Rd , Pickering, Ontario CANADA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: Rapid Response COVID-19 Antigen Rapid Test Device

Biochem Immunosystems Inc
Date Published : 09/16/2009
10900 Hamon St. , Montreal, QC CANADA
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: HIV 1/2 Saliva Test Kit (aka Easy Home Test or easyhivtest). 9/14/2000. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Biointegral Surgical
Date Published : 11/13/2012
1 200 Britannia Rd E , Mississauga, On CANADA
74 D - - XZ Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene
Date Published: 11/13/2012

Desc: Porcine Pericardial Patch
Notes: Class II

74 L - - WR Tissue, Heart-Valve
Date Published: 11/13/2012

Desc: Injectable Bio-Pulmonic Pulmonic Valve
Notes: Class III

74 L - - WR Tissue, Heart-Valve
Date Published: 11/13/2012

Desc: BioMitral Bio-Aortic Replacement Aortic and Mitral Valve
Notes: Class III

74 - - - -- Cardiovascular
Date Published: 11/13/2012

Desc: MitroFix Mitral Valve Restoration

Biotronics Research Corporation
Date Published : 09/16/2009
1104-3760 Albert Street , Burnaby, BC CANADA
87 L - - OE Stimulator, invasive bone growth
Date Published: 01/23/2019

Desc: Bone Growth Stimulator
Notes: Class III; 10/28/2005

87 L - - OF Stimulator, bone growth, non-invasive
Date Published: 01/23/2019

Desc: Bone Growth Stimulator
Notes: Class III; 10/28/2005

Biotronix 2000 Inc. (Lg Technologies)
Date Published : 01/23/2019
2185 Rue Michelin , Laval, QC CANADA
80 K - - ZH Introducer, Syringe Needle
Date Published: 01/23/2019

Desc: Needlesafe; all models; including NX3000; NX2000; NX1000; NX5000 SDS
Notes: 8/19/1998

80 M - - MK Container, Sharps
Date Published: 01/23/2019

Desc: Sharpes Container sold with Model NX5000 SDS and alone
Notes: 8/19/1998

Birthcontrol.com
Date Published : 01/30/2019
1269 56th. street #18037 , Delta, BC CANADA
85 L - - LQ Cap, Cervical, Contraceptive
Date Published: 01/30/2019

Desc: Persona Contraceptive Monitor
Notes: Class III device 5/8/2001

CANARY GLOBAL INC
Date Published : 04/01/2022
5063 North Service Rd , Burlington, Ontario CANADA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/01/2022

Desc: Pelican COVID-19 Ultra-Rapid Mobile Test for At-Home Testing

CARDIAI INC.
Date Published : 09/30/2021
201-3151 27 St Ne , Calgart, Alberta CANADA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: CoviLampTM SARS-CoV-2 High-throughput Fluorometric Test Kit

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: CoviLamp High- throughput Fluorometric Test Kit

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: CoviLamp Fluorometric Test Kit

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: CoviLAMP Screening Kit for SARS-CoV-2

Cardston Medical Research
Date Published : 08/15/2014
1718 Edinburgh St , New Westminster, BC CANADA
84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief)
Date Published: 08/15/2014

Desc: Victoria Machine/cranial electro stimulator (modes; Gem zapper; cranial electro stimulator; colloidial silver; blood electrifier) Device
Notes: Class II

84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief)
Date Published: 08/15/2014

Desc: Magnetic Pulser (1Amp Fuse; 110VAC) Device
Notes: Class II

84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief)
Date Published: 08/15/2014

Desc: Ultimate Cancer Care (modes; zapper; sarcoma; carcinoma; colloidal silver) device and accessories;
Notes: Class II

84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief)
Date Published: 08/15/2014

Desc: Electric massager (part 1 & 2; HIC 9019-1020 & HIC 9010-1020); TDP CP-27IR-Heater Lamp
Notes: Class II

84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief)
Date Published: 08/15/2014

Desc: Tri-Medica (modes; gem zapper; colloidial silver; blood electrifier)
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 08/15/2014

Desc: Electric massager (part 1 & 2; HIC 9019-1020 & HIC 9010-1020); TDP CP-27IR-Heater Lamp
Notes: Class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 08/15/2014

Desc: Victoria Machine/cranial electro stimulator (modes; Gem zapper; cranial electro stimulator; colloidial silver; blood electrifier) Device
Notes: Class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 08/15/2014

Desc: Magnetic Pulser (1Amp Fuse; 110VAC) Device
Notes: Class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 08/15/2014

Desc: Ultimate Cancer Care (modes; zapper; sarcoma; carcinoma; colloidal silver) device and accessories;
Notes: Class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 08/15/2014

Desc: Electric massager (part 1 & 2; HIC 9019-1020 & HIC 9010-1020); TDP CP-27IR-Heater Lamp
Notes: Class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 08/15/2014

Desc: Tri-Medica (modes; gem zapper; colloidial silver; blood electrifier)
Notes: Class II

Comptronics Devices Limited
Date Published : 09/16/2009
9008-51 Avenue , Edmonton, Alberta, CANADA
84 J - - XK Cranial electrotherapy stimulator to treat depression
Date Published: 09/16/2009

Notes: 6/29/2000 Oasis Cranial Electrotherapy Stimulator (CES)

Customer Service (Northern Response)
Date Published : 03/08/2011
18 Skagway Avenue , Scarborough, ON CANADA
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Stimulator Electro-Acupuncture
Notes: Class III

DAMIVA
Date Published : 12/13/2017
55 Avenue Rd Suite #2400 , Toronto, Ontario CANADA
62 M - - 99 Anti-Pruritic N.E.C.
Date Published: 12/13/2017

Desc: Mae Vaginal Suppository
Notes: Class II device without a valid 510K

85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible
Date Published: 12/13/2017

Desc: Mae Vaginal Suppository
Notes: Class II device without a valid 510K

Damiva Inc
Date Published : 12/13/2017
639 Dupont St Unit 228 , Toronto, Ontario CANADA
62 M - - 99 Anti-Pruritic N.E.C.
Date Published: 12/13/2017

Desc: Mae Vaginal Suppository
Notes: Class II device without a valid 510K

85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible
Date Published: 12/13/2017

Desc: Mae Vaginal Suppository
Notes: Class II device without a valid 510K

Datrend Systems Inc.
Date Published : 03/20/2012
5355 Parkwood Pl , Richmond, British Columbia CANADA
74 D - - PS Electrocardiograph
Date Published: 03/20/2012

Desc: ECG Arrhythmia Simulator Model 10A and 20A
Notes: Class II

74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Date Published: 03/20/2012

Desc: ECG Arrhythmia Simulator Model 10A and 20A
Notes: Class II

Dectro International, Inc.
Date Published : 04/30/2014
1000 Du Parc-Technologique Blvd , Quebec, Quebec CANADA
79 K - - CW Epilator, High Frequency, Needle-Type
Date Published: 01/13/2015

Desc: Angie Thermocoagulation System (Epilator)
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/13/2015

Desc: Vitaderm 4000 System (Electric Therapeutic Massager)
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/13/2015

Desc: Vitalift System (Electric Therapeutic Massager)
Notes: class II

89 K - - NM Device, Pressure Applying
Date Published: 01/13/2015

Desc: Vitalymph Pressotherapy System (Pressure Applying Device)
Notes: class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 01/13/2015

Desc: Vital-Ultra Anti-Cellulite System (Manual Therapeutic Massager)
Notes: class II

Dr-ho's Inc
Date Published : 10/01/2010
13-176 Bullock Dr , Markham, Ontario CANADA
84 H - - ST Apparatus, traction, non-powered
Date Published: 11/08/2018

Desc: Neck Comforter
Notes: Class I

89 K - - NM Device, Pressure Applying
Date Published: 10/01/2010

Desc: Neck Comforter
Notes: Class I

Eidam Diagnostic Corp.
Date Published : 04/14/2014
140-11120 Horseshoe Way , Richmond, British Columbia CANADA
85 L - - HQ System, Telethermographic (Adjunctive Use)
Date Published: 04/14/2014

Desc: CRT2000 Thermographic System
Notes: Class II

90 L - - HQ System, telethermographic (adjunctive use)
Date Published: 07/24/2017

Desc: CRT2000 Thermographic System
Notes: Class II

Eidam Diagnostics Corp
Date Published : 04/14/2014
13777 Commerce Parkway Rm 101 , Richmond, BC CANADA
85 L - - HQ System, Telethermographic (Adjunctive Use)
Date Published: 04/14/2014

Desc: CRT2000 Thermographic System
Notes: Class II

90 L - - HQ System, telethermographic (adjunctive use)
Date Published: 07/24/2017

Desc: CRT2000 Thermographic System
Notes: Class II

Electro Medica Office
Date Published : 03/08/2011
Rr 2 , Burnt River, Ontario CANADA
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Sonafon Sonic Acupuncture
Notes: Class III

Fidelity Electronics
Date Published : 09/16/2009
5796 Ambler Dr , Mississauga, ON CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE. 5/6/1994

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Globus Media
Date Published : 09/16/2009
9390 Pie-Ix Blvd , Montreal, Quebec CANADA
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 01/30/2019

73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All medical devices. GPI = DE, DI, BI, SD. 2/9/2005. The firm is known to have shipped and/or marketed the following products in the US Rapid HIV Test Kit, Class III device, Rapid Syphilis Test Kit, Class III Device, One Step Casette Style Cocaine Test Kit, Class II device, One Step Cassette Style Marijuana THC Test Kit, Class II device, One Step Cassette Style Amphetamine Test Kit, Class II Device, Rapid Dangue Fever Test Kit Class III device, One Step Midstream style HCG Urine Home Pregnancy Test Kit, Class III device. If districts encounter shipments of any device from the above shipper/markerting firm, contact DIOP attn Sammi Hadden 301-827-9632

74 - - - -- Cardiovascular
Date Published: 09/16/2009

75 - - - -- Chemistry
Date Published: 01/30/2019

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

81 - - - -- Hematology
Date Published: 01/30/2019

82 - - - -- Immunology
Date Published: 01/30/2019

83 - - - -- Microbiology
Date Published: 01/30/2019

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

88 - - - -- Pathology
Date Published: 01/30/2019

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

91 - - - -- Toxicology
Date Published: 01/30/2019

92 - - - -- Molecular Genetics
Date Published: 01/30/2019

Haven by the Sea
Date Published : 03/08/2011
240 Davis Road , Gabriola Island, British Columbia CANADA
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Search N Stim Electronic Acupuncture
Notes: Class III

Health Care Products Inc
Date Published : 09/16/2009
165 Matheson Blvd E Suite 8 , Mississauga, ON CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE. Wipeout Long Life Activated Dialehyde. 4/27/1993.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Health Light Inc
Date Published : 09/16/2009
P O Box 3899 Station C , Hamilton, ON CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE. Seasonal Affective Disorder Lights (SAD Lights) 2/4/1992

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Innovatech Designs
Date Published : 09/29/2009
Dollards Des Ormeaux, Pq , 460 Hampton Court St , Dollard-Des-Ormeaux, Quebec CANADA
78 L - - KY Device, External Penile Rigidity
Date Published: 09/29/2009

Notes: Class III; 3/5/09

78 N - - HU Extender, Penile, Mechanical
Date Published: 09/29/2009

Notes: Class III; 3/5/09

Innovative Ionizing Technologies
Date Published : 01/23/2019
12527 21a Ave , Surrey, BC CANADA
90 I - - WI Source, Isotope, Sealed, Gold, Titanium, Platinum
Date Published: 01/23/2019

Desc: Scalar Energy Pendants
Notes: Class II; 6/26/2015

90 K - - XK Source, Brachytherapy, Radionuclide
Date Published: 01/23/2019

Desc: Scalar Energy Pendants
Notes: Class II; 6/26/2015

International Biotech Corporation
Date Published : 09/16/2009
#616, 10216-124 St , Edmonton, AB CANADA
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: 11/9/1999. HIV 1/2 Blood Test Kit. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: 11/9/1999. HIV 1/2 Blood Test Kit. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

J.K.Orthomedic,Ltee. aka Kirshner Canada
Date Published : 09/16/2009
1755 St. Regis 210 , Dollard des Ormeaux , Quebec, QC CANADA
87 L - - ML Ligaments And Tendons, Synthetic
Date Published: 09/16/2009

Notes: LARS (Ligament Advanced Reinforcement System) 10/13/1995

Kwicksilver Electronics
Date Published : 01/23/2019
1730 Whalebone Drive , Gabriola Island, British Columbia CANADA
84 - - - -- Neurological
Date Published: 01/23/2019

Desc: The New Original Parasite Zapper
Notes: Class II; 7/2/2002

84 - - - -- Neurological
Date Published: 01/23/2019

Desc: The Original Parasite Zapper
Notes: Class III; 7/2/2002

Lubecki Technical Holdings, Inc.
Date Published : 08/26/2012
435 Saint-Vallier St , Granby, Quebec CANADA
78 L - - KY Device, External Penile Rigidity
Date Published: 08/26/2012

Desc: John's Only Pump Enlargement Pump
Notes: Class II

78 N - - HU Extender, Penile, Mechanical
Date Published: 08/26/2012

Desc: John's Only Pump Enlargement Pump
Notes: Class II

MedMira Laboratories Inc.
Date Published : 01/29/2021
Suite 1 Unit 1 , 155 Chain Lake Dr , Halifax, Nova Scotia CANADA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/29/2021

Desc: REVEALCOVID-19 %u2122 Total Antibody Test

Medica Outlet
Date Published : 06/11/2015
Toronto Eaton Centre , 1 Dundas St W Suite 2601 , Toronto, Ontario CANADA
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 06/11/2015

Desc: Teosyal
Notes: Class III. Teosyal is a dermal filler intended for treating wrinkles; adding contour to facial features; enhancing the lips and eliminating the appearance of aging. The product is marketed on www.medicaoutlet.com.

Norgen Biotek Corp./haj-ahmad
Date Published : 05/28/2021
3430 Schmon Pky , Ss 11 , Thorold, Ontario CANADA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/28/2021

Desc: Kaya17 nCoVega COVID-19 Antigen Test

Northern Light Technologies
Date Published : 09/16/2009
3070 Brabant-Marineau St , Saint Laurent, Quebec CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. DWI = DE. Seasonal Affective Disorder Lights (SAD Lights) 2/3/1992.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Oa Internet Svcs Ltd
Date Published : 11/28/2011
5764 Av De Monkland , Montreal, Quebec CANADA
78 L - - -- Portion of device code
Date Published: 11/28/2011

Desc: Andro Penis Extender
Notes: Class II

78 L - - -- Portion of device code
Date Published: 11/28/2011

Desc: Vimax System
Notes: Class II

78 N - - -- Portion of device code
Date Published: 06/04/2019

Desc: Vimax System
Notes: Class II; 11/28/2011

78 N - - -- Portion of device code
Date Published: 11/28/2011

Desc: Andro Penis Extender
Notes: Class II

Oped Canada Distribution
Date Published : 09/16/2009
344 Townsend Ave , Burlington, ON CANADA
87 L - - OE Stimulator, invasive bone growth
Date Published: 06/04/2019

Desc: Matrix II; Bone Growth Stimulator
Notes: The manufacturers website                         and the user manual shipped with the product states the product ; Class III; 10/28/2005

87 L - - OF Stimulator, bone growth, non-invasive
Date Published: 06/04/2019

Desc: Matrix II; Bone Growth Stimulator
Notes: The manufacturers website                         and the user manual shipped with the product states the product ; Class III; 10/28/2005

PLATINUM ENERGY SYSTEMS (CANADA)
Date Published : 01/10/2017
1136B Wychbury Ave , Victoria, British Columbia CANADA
89 I - - LJ Bath, Hydro-Massage
Date Published: 01/10/2017

Desc: PES Detox System (foot bath)

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/10/2017

Desc: PES Detox System (foot bath)

PROPRIETARY INNOVATION LABS INC.
Date Published : 07/17/2020
345 Wilson Ave Suite 306 , North York, Ontario CANADA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)

Preferred Medical Products
Date Published : 09/16/2009
3280 Schmon Parkway , Thorold, ON CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE. Spinal Anethesia trays containing tetracaine hydrochloride for use in the pediatric population. (3/5/1993 Continuous Spinal Anethesia Trays non-pediatric) (7/30/1993 Epi-spinal Tray Re-Order #2002 Epi Spinal Mini Kit Reorder #2005)

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Pronto Innovations
Date Published : 03/09/2012
601 Gordon Baker Rd , North York, Ontario CANADA
84 M - - VV Device, Acupressure
Date Published: 03/09/2012

Desc: Motion Relief Wrist Bands
Notes: class II

R. OH Canada
Date Published : 09/20/2011
1365 Beaumont Ave. , Po Box 65511 , Montreal, Alberta CANADA
78 L - - -- Portion of device code
Date Published: 09/20/2011

Desc: Any Penile Corrective Devices
Notes: Class III

78 N - - -- Portion of device code
Date Published: 09/20/2011

Desc: Any Penile Corrective Devices
Notes: Class III

R. Oh Canada
Date Published : 09/20/2011
6855 De L'Epee Avefloor: 3 Unit: 302 , Montrealmontreal, QUEBEC CANADA
78 L - - -- Portion of device code
Date Published: 09/20/2011

Desc: Any Penile Corrective Devices
Notes: Class III

78 N - - -- Portion of device code
Date Published: 09/20/2011

Desc: Any Penile Corrective Devices
Notes: Class III

Response Biomedical Corp.
Date Published : 09/30/2021
1781 75th Ave W , Vancouver, British Columbia CANADA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/30/2021

Desc: RAMP COVID-19 Antigen Test

SONA NANOTECH
Date Published : 05/14/2021
2001-1969 Upper Water St , Halifax, Nova Scotia CANADA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/14/2021

Desc: COVID-19 LFA

SONA NANOTECH
Date Published : 05/14/2021
2-1 Research Dr , Dartmouth, Nova Scotia CANADA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/14/2021

Desc: COVID-19 LFA

Seville Marketing
Date Published : 09/16/2009
3017 Mountain Hwy , P.O. Box 16047 , North Vancouver, British Columbia CANADA
82 - - - -- Immunology
Date Published: 09/16/2009

Notes: 10/26/1999. Discreet HIV Test. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Silhouet-Tone Corporation
Date Published : 09/20/2013
2185 Michelin St , Laval, Quebec CANADA
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 09/20/2013

Desc: Lipomax RF
Notes: clas II

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 09/20/2013

Desc: Lumicell Wave
Notes: class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 09/20/2013

Desc: Lipomax RF
Notes: class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 09/20/2013

Desc: Lumicell Wave
Notes: class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 09/20/2013

Desc: Lumicell Wave
Notes: class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 09/20/2013

Desc: Lipomax RF
Notes: class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 09/20/2013

Desc: Lipomax RF
Notes: class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 09/20/2013

Desc: Lumicell Wave
Notes: class II

89 I - - RO Vibrator, Therapeutic
Date Published: 09/20/2013

Desc: Lumicell Wave
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/20/2013

Desc: Lumicell Wave
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/20/2013

Desc: Lipomax RF
Notes: Class II

Softlaser International, Inc.
Date Published : 09/16/2009
unknown , unknown, Ontario CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Sudor Inc.
Date Published : 09/16/2009
P.O. Box 383 , Collingwood, ON CANADA
84 - - - -- Neurological
Date Published: 09/16/2009

Notes: 10/20/1999 Ground Zero; Ground System and method for organisms (Ground Zero Grounding Device)

The One and Only Fashion Beauty Group, Inc.
Date Published : 09/16/2009
74 Simcoe Road , Kettleby, Ontario, CANADA
86 H - - PK Tonograph
Date Published: 09/16/2009

Notes: Decorative Contact Lenses. 4/7/2006.

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 09/16/2009

Notes: Decorative Contact Lenses. 4/7/2006.

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 09/16/2009

Notes: Decorative Contact Lenses. 4/7/2006.

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 09/16/2009

Notes: Decorative Contact Lenses. 4/7/2006.

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 09/16/2009

Notes: Decorative Contact Lenses. 4/7/2006.

86 M - - VN Lens, Contact (Disposable)
Date Published: 09/16/2009

Notes: Decorative Contact Lenses. 4/7/2006.

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 09/16/2009

Notes: Decorative Contact Lenses. 4/7/2006.

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 09/16/2009

Notes: Decorative Contact Lenses. 4/7/2006.

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 09/16/2009

Notes: Decorative Contact Lenses. 4/7/2006.

Ultrasoft Laboratories Ltd
Date Published : 09/16/2009
8855 Northbrook Court , Burnaby, BC CANADA
86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 09/16/2009

Notes: Contact lenses, all types. 2/9/1993

VGH Solutions Inc.
Date Published : 10/01/2010
145 Anderson Ave , Markham, Ontario CANADA
84 H - - ST Apparatus, traction, non-powered
Date Published: 11/08/2018

Desc: Neck Comforter
Notes: Class I

89 K - - NM Device, Pressure Applying
Date Published: 10/01/2010

Desc: Neck Comforter
Notes: Class I

Vgh Solutions Inc
Date Published : 10/01/2010
176 Bullock Dr #113 , Markham, Ontario CANADA
84 H - - ST Apparatus, traction, non-powered
Date Published: 11/08/2018

Desc: Neck Comforter
Notes: Class I

89 K - - NM Device, Pressure Applying
Date Published: 10/01/2010

Desc: Neck Comforter
Notes: Class I

Victory Square Health Canada, Inc.
Date Published : 01/26/2021
1080-789 Pender St W , Vancouver, British Columbia CANADA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: Safetest Covid-19 IgG/IgM Rapid Test

X4 Laboratories, Incorporated
Date Published : 09/20/2011
1365 Beaumont Ave. , Cp 65511 Csp Beaumont , Mont-Royal, Quebec CANADA
78 L - - -- Portion of device code
Date Published: 09/20/2011

Desc: Any Penile Corrective Devices
Notes: Class III

78 N - - -- Portion of device code
Date Published: 09/20/2011

Desc: Any Penile Corrective Devices
Notes: Class III

X4 Labs Inc.
Date Published : 09/16/2009
6855 De L'Epee Ave. , Montreal, QC CANADA
78 L - - KY Device, External Penile Rigidity
Date Published: 09/16/2009

Notes: x4 Penile corrective device. 9/16/2008

78 L - - -- Portion of device code
Date Published: 09/20/2011

Desc: Any Penile Corrective Devices
Notes: Class III

78 N - - HU Extender, Penile, Mechanical
Date Published: 09/16/2009

Notes: x4 Penile corrective device. 9/16/2008

78 N - - -- Portion of device code
Date Published: 09/20/2011

Desc: Any Penile Corrective Devices
Notes: Class III

YCY Prosperity Holdings Ltd.
Date Published : 09/14/2011
9253 Shaughnessy St , Vancouver, British Columbia CANADA
89 I - - RO Vibrator, Therapeutic
Date Published: 09/14/2011

Desc: iDream 1260 Head Massager
Notes: CLASS; I/II

89 I - - RT Pad, Heating, Powered
Date Published: 09/14/2011

Desc: iDream 1260 Head Massager
Notes: CLASS; I/II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/14/2011

Desc: iDream 1260 Head Massager
Notes: CLASS; I/II

89 K - - NM Device, Pressure Applying
Date Published: 09/14/2011

Desc: iDream 1260 Head Massager
Notes: CLASS: I/II


CHILE


TAAG GENETICS SA
Date Published : 01/10/2022
Av Rio Refugio 9641 Ene , Santiago, CHILE
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/10/2022

Desc: nPLEX SARS-CoV-2 Detection Kit


CHINA


AI DE DIAGNOSTIC CO LTD
Date Published : 04/20/2022
No. 87 Zhuzhu Road, Nancun , Town, Pingdu , Qingdao, CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2022

Desc: SARS-CoV-2 IgG/IgM Antibody Test

AI DE Diagnostic Co Ltd
Date Published : 04/20/2022
High-Tech Indu. Park , Zhuzhou Road; Laoshan , Qingdao, Shandong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2022

Desc: SARS-CoV-2 IgG/IgM Antibody

ANBIO (XIAMEN) BIOTECHNOLOGY CO
Date Published : 05/04/2021
2016 Wengjio W Rd Xinyj , Xiamen, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 02/10/2023

Desc: Rapid COVID-19 Antigen Test (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/04/2021

Desc: COVID-19 IgM/IgG Antibody Colloidal Gold Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/04/2021

Desc: Rapid COVID-19 Antigen Test (Colloidal Gold)

83 Q - - MN COVID-19 Multi-Analyte Antigen Device
Date Published: 02/10/2023

Desc: Rapid COVID-19 Antigen Test (Colloidal Gold)

ANYGO TECHNOLOGY
Date Published : 05/14/2021
10b-Building A, Hang Bu , Futian Dist Shenzhen, CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: COVID-19 Capture ELISA Assay

ANYGO TECHNOLOGY
Date Published : 05/14/2021
D # 1117 , 89 Dayangfang Ro , Beijing, CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: COVID-19 Capture ELISA Assay

ANYGO TECHNOLOGY C
Date Published : 05/14/2021
89 Da Yang Fang Rd , Beijing, CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: COVID-19 Capture ELISA Assay

Ablelink Electronics LTD
Date Published : 02/24/2021
Qingzhang Road , 182 Qingxi Changshantoucun; Qingxi Towntou , Dongguan, Guangdong CHINA
76 L - - BH Varnish, Cavity
Date Published: 02/24/2021

Desc: Desensitizing Wand

Abound Texfactory
Date Published : 03/08/2013
G F 5th Bldg Metal , Guangzhou, CHINA
86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 03/08/2013

Desc: Nocturns Anti-Glare Glasses
Notes: class II

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 03/08/2013

Desc: Nocturns Anti-Glare Glasses
Notes: class II

86 N - - JH Lens, Spectacle (Prescription), for Reading Discomfort
Date Published: 03/08/2013

Desc: Nocturns Anti-Glare Glasses
Notes: class II

Abound Texfactory
Date Published : 03/08/2013
38 Xinmin 4 St , Guangzhou, CHINA
86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 03/08/2013

Desc: Nocturns Anti-Glare Glasses
Notes: class II

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 03/08/2013

Desc: Nocturns Anti-Glare Glasses
Notes: Class II

86 N - - JH Lens, Spectacle (Prescription), for Reading Discomfort
Date Published: 03/08/2013

Desc: Nocturns Anti-Glare Glasses
Notes: class II

Amoy Diagnostics Co. Ltd.
Date Published : 05/24/2013
5th Floor, No. 4 Plant, Kechuang Ctr , 289 Wengjiao Rd., Xinyang St., Haicang , Xiamen, Fujian, CHINA
81 M - - VU Reagents, Specific, Analyte
Date Published: 05/24/2013

Desc: Mutation Detection Kit
Notes: Class III

88 N - - QF Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
Date Published: 05/24/2013

Desc: Mutation Detection Kit
Notes: class III

Anhui Deepblue Medical Technology Co Ltd
Date Published : 05/04/2021
No. 777 Huangshan Road , Shushan , Hefei, Anhui CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/04/2021

Desc: Immune Colloidal Gold Lateral Flow Strip for IgG & IgM of SARS-CoV-2

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/04/2021

Desc: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/04/2021

Desc: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Anhui Tongzhou Electronic Sci-Tech Co., Ltd.
Date Published : 06/02/2011
NO. 539 Wangjiangxilu , Baohe , Hefei, Anhui CHINA
87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 08/25/2023

Desc: Portable Smart Massage U Disc Tens Unit
Notes: Class II

As Tec Group
Date Published : 06/15/2016
Be Xing Bao Yi Industrial Bld , Shenzhen, CHINA
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 06/15/2016

Desc: Digital TENS Massage Therapy Machine
Notes: Class II; There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market.

84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 06/15/2016

Desc: Digital Massage Therapy Machine
Notes: Class II; There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market.

89 I - - SA Massager, Therapeutic, Electric
Date Published: 06/15/2016

Desc: Digital TENS Massage Therapy Machine
Notes: Class II;There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market.

89 I - - SA Massager, Therapeutic, Electric
Date Published: 06/15/2016

Desc: Digital Massage Therapy Machine
Notes: Class II;There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market.

Assure Tech (Hangzhou) Co., Ltd
Date Published : 06/22/2021
Nd-5th Floor, Building 4 1418 , 50 Moganshan Road; Gongshu , Hangzhou, Zhejiang CHINA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: Rapid Response COVID-19 Antigen Rapid Test Device

Atlas Link (Beijing) Technology Co Ltd
Date Published : 07/07/2020
Ze Yang Plaza Room 811 , Beijing, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/07/2020

Desc: NOVA COVID-19 IgG/IgM Antibody Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/07/2020

Desc: NOVA COVID-19 IgG/IgM Antibody Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/07/2020

Desc: NOVA COVID-19 IgG/IgM Antibody Rapid Test

Autobio Diagnostics Co Ltd
Date Published : 09/02/2020
National Eco &Tech , Development Area , Zhengzhou, Henan CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/02/2020

Desc: Anti- SARS-COV-2 Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/02/2020

Desc: Anti- SARS-COV-2 Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/02/2020

Desc: Anti- SARS-COV-2 Rapid Test

BEIJING ADSS DEVELOPMENT CO., LTD
Date Published : 02/01/2024
Adss Industrial Park , Tongsheng Road; South Development Zone , Langfang, CHINA
79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 02/01/2024

Desc: PDT Machine

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 02/01/2024

Desc: Beauty Machine

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 02/01/2024

Desc: PDT Machine

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 02/01/2024

Desc: Beauty Machine

BEIJING DIAGREAT BIOTECHNOLOGIES Co Ltd
Date Published : 09/02/2020
Xinhualian Science And Technology Building 3rd Floor , 5 Jaichuang Rd , Beijing, Beijing CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/02/2020

Desc: 2019-nCoV IgG Antibody Determination Kit

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/02/2020

Desc: 2019-nCoV IgM A

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/02/2020

Desc: 2019-nCOV IgG/IgM Antibody Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/02/2020

Desc: 2019-nCOV IgG/IgM Antibody Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/02/2020

Desc: 2019-nCoV IgG Antibody Determination Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/02/2020

Desc: 2019-nCoV IgM A

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/02/2020

Desc: 2019-nCoV IgG Antibody Determination Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/02/2020

Desc: 2019-nCoV IgM A

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/02/2020

Desc: 2019-nCOV IgG/IgM Antibody Rapid Test Kit

BEIJING GLOBALIPL DEVELOPMENT CO Ltd
Date Published : 11/01/2013
Qunyinghui Building F 8 , 32 Jinyuan Road; Daxing , Beijing, Beijing CHINA
95 R - - HG Light, Spectrum, Broad (Non-Medical), General Optical Products, Non-Medical
Date Published: 11/01/2013

Desc: E Light (IPL RF) Beauty Equipment
Notes: Class II

BEIJING GLOBALIPL DEVELOPMENT CO Ltd
Date Published : 04/04/2012
Qunyinghui Building F 8 , 32 Jinyuan Road; Daxing , Beijing, Beijing CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 04/04/2012

Desc: US309F Slimming Machine
Notes: Class II/III

89 I - - LX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 04/04/2012

Desc: US309F Slimming Machine
Notes: Class II/III

95 R - - HG Light, Spectrum, Broad (Non-Medical), General Optical Products, Non-Medical
Date Published: 11/01/2013

Desc: E Light (IPL RF) Beauty Equipment
Notes: Class II

BEIJING GOLDENLASER DEVELOPMENT CO., LTD.
Date Published : 05/29/2012
1st Floor # 339 , Shenwei North Rd; Yanjiaozhen Sanhe , Langfang, Hebei CHINA
89 I - - LX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 05/29/2012

Desc: GL029 RF Cavitation Equipment
Notes: Class; Unknown

89 I - - SA Massager, Therapeutic, Electric
Date Published: 05/29/2012

Desc: GL029 RF Cavitation Equipment
Notes: Class; Unknown

BEIJING HOTGEN BIOTECH CO LTD
Date Published : 07/27/2021
Hongxing Lou 9th , No. 9 Tianfu Street , Daxing, Beijing CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: Novel Coronavirus 2019- nCoV Antigen Test (Colloidal Gold)

BEIJING SONGIC LASER COMPANY
Date Published : 11/01/2017
Tongzhou District , Beijing, CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 11/01/2017

Desc: Hair Removal Laser System
Notes:                                                                                                                                                                                                                                                                                        

BESTNOVO MEDICAL TECHNOLOGY
Date Published : 06/23/2020
Fl 4 , No. 73 Bldg G57 , Taizhou, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/23/2020

Desc: BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/23/2020

Desc: BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/23/2020

Desc: BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit

BESTYLE GIFT & PAC
Date Published : 03/17/2021
Room 515 , Blk 1 C , Shenzhen, CHINA
86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 03/17/2021

Desc: Heated Dry Eye Mask
Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation.

86 O - - RZ Lipiflow thermal pulsation system, EYELID THERMAL PULSATION SYSTEM
Date Published: 03/17/2021

Desc: Heated Dry Eye Mask
Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation.

BIOHIT HEALTHCARE (HEIFEI) CO LT
Date Published : 06/22/2021
Bldg D Innovation Pk We , No. 800 Wangjiang West Rd; Shushan , Hefei, Anhui CHINA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/04/2022

Desc: Hough Covid-19 Home Test

BIOSCIENCE(TIANJIN) DIAGNOSTIC TECHNOLOGY CO.,LTD
Date Published : 06/23/2020
No.201.10 Siwei Road,Dongli District,Tianjin,China , No.14, International Medical Device Park, Liujing Road, Dongli Economic And Technology Development District , Tianjin, Tianjin CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/23/2020

Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/23/2020

Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/23/2020

Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/23/2020

Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/30/2021

Desc: Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/23/2021

Desc: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/30/2021

Desc: Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/23/2020

Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/23/2020

Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody

BIOSINO BIO-TECHNOLOGY
Date Published : 03/02/2021
27 Chaoqian Rd , Bejing, CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/02/2021

Desc: SARS-CoV-2 Antibody Test

BIOTEKE CORPORATION (WUXI) CO., LTD
Date Published : 07/27/2021
4th Floor , D5 No.1719,Huishan Avenue , Wuxi City, Jiangsu CHINA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: 2019-nCoV Antigen Test Kit (colloidal gold method)

Balon Beauty Factory
Date Published : 12/14/2011
138 Area B Industrial Zone 3 , Guangzhou, CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 12/14/2011

Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

79 G - - FE Brush, Dermabrasion
Date Published: 12/14/2011

Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

89 I - - SA Massager, Therapeutic, Electric
Date Published: 12/14/2011

Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

97 R - - AF Cleaner, Ultrasonic Non-Medical Devices
Date Published: 12/14/2011

Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon & Ultrasonic) ;

Beijing ADSS Development Co., Ltd.
Date Published : 04/24/2013
F2, BLDG., JINYUAN RD. 36 , Daxing Economic Development zone , Beijing, Beijing CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 04/24/2013

Desc: 4S Beauty System
Notes: Class II

79 N - - SY Stimulator, Light, Aesthetic
Date Published: 04/24/2013

Desc: 4S Beauty System
Notes: Class II

79 O - - NE Powered light based non-laser surgical instrument
Date Published: 04/24/2013

Desc: 4S Beauty System
Notes: Class II ;

79 O - - NF Powered light based non-laser surgical instrument with thermal effect
Date Published: 04/24/2013

Desc: 4S Beauty System
Notes: Class II

79 O - - NQ electrosurgical coagulation for aesthetic
Date Published: 04/24/2013

Desc: 4S Beauty System
Notes: Class II ;

79 O - - UH Skin resurfacing rf applicator
Date Published: 04/24/2013

Desc: 4S Beauty System
Notes: Class II ;

79 O - - YW For the removal of fat through laser lipolysis
Date Published: 04/24/2013

Desc: 4S Beauty System
Notes: Class II

95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 04/24/2013

Desc: 4S Beauty System
Notes: Class II

95 R - - HL Laser therapy product
Date Published: 04/24/2013

Desc: 4S Beauty System
Notes: Class II

Beijing Beier Bioengineering Co., LTD
Date Published : 04/15/2021
No. 99 Chuangxin Road , Lucheng Industrial Development Zone Huangcun Town , Daxing, Beijing CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/15/2021

Desc: 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)

Beijing Bioneovan Co.Ltd
Date Published : 07/05/2016
No. 18 Keyuan Road , Daxing Industry Zone , Beijing , CHINA
82 M - - ZF Test, HIV Detection
Date Published: 07/05/2016

Desc: HIV Rapid Test

Beijing Cosmelights Technology Co Ltd
Date Published : 12/10/2014
Room 2705 1 Xinghualu , Beijingshi, Beijingshi CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 12/10/2014

Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser)
Notes: class 2

79 O - - HT Light based over-the-counter hair removal
Date Published: 12/10/2014

Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser)
Notes: class 2

79 O - - NE Powered light based non-laser surgical instrument
Date Published: 12/10/2014

Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser)
Notes: class 2

Beijing Decombio Biotechnology Co., Ltd
Date Published : 07/07/2020
17 Jingsheng Nan Fourth Street , Tongzhou , Beijing, Beijing CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/07/2020

Desc: Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/07/2020

Desc: Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/07/2020

Desc: Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)

Beijing Genesee Biotech, Inc.
Date Published : 02/20/2018
No. 36, Yanqi Donger Road , Huairou Yanqi Industrial Dev Zn , Beijing, CHINA
83 J - - SY Kit, Identification, Mycobacteria
Date Published: 02/20/2018

Desc: Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit
Notes:                                                                                                                                                                                                                                                                                                                                                          

83 L - - OM Hepatitis B Test (B Core, Be Antigen, Be Antibody, And B Core Igm)
Date Published: 02/20/2018

Desc: Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit
Notes:                                                                                                                                                                                                                                                                                                                                                            

Beijing Medical Radiology Factory
Date Published : 02/22/2013
Lang Jia Yuan 6 Jianwaidajie , Beijingshi, Beijingshi CHINA
79 M - - YH System, Non-Coherent Light, Photodynamic Therapy
Date Published: 02/22/2013

Desc: Led Photorejuvenation Device
Notes: Class II

95 R - - HG Light, Spectrum, Broad (Non-Medical), General Optical Products, Non-Medical
Date Published: 02/22/2013

Desc: Led Photorejuvenation Device
Notes: class II

95 R - - HL Laser therapy product
Date Published: 02/22/2013

Desc: Led Photorejuvenation Device
Notes: class II

Beijing Sanhe Beauty S & T Co., Ltd
Date Published : 08/22/2016
Building NO. 4 3rd Floor , Maohuagongchang, Nancaizhen , Beijing, Shunyi District CHINA
79 O - - NF Powered light based non-laser surgical instrument with thermal effect
Date Published: 08/22/2016

Desc: IPL SHR E-Light device

Beijing Shhb Technology Co Limited
Date Published : 09/20/2016
No 485 Zhong Hua North Street , Handan, Hebei CHINA
79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite
Date Published: 09/20/2016

Desc: ETG50-4S Cryolipolysis System

Beijing Sunshine E&M Co
Date Published : 10/01/2010
42 Yangrouhutong , Beijingshi, Beijing CHINA
84 H - - ST Apparatus, traction, non-powered
Date Published: 11/08/2018

Desc: Neck Comforter
Notes: Class I

89 K - - NM Device, Pressure Applying
Date Published: 10/01/2010

Desc: Neck Comforter
Notes: Class I

Beijing Toplaser Technology Co., Ltd.
Date Published : 09/16/2009
East 3rd Floor, Building M7 , NO. 1 Jiuxianqiao Donglu , Beijing, Beijing CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE. 10/7/2008. CDRH has indicated DWPE of said products requiring 510k approval only if its being imported by                                                                                    Beijing Toplaser Technology Co. Ltd and                         have no cleared or pending 510ks with CDRH.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 G - - EX Powered laser surgical instruments
Date Published: 01/30/2019

Desc: NannoLight MP-50 Intense Pulsed Light and Laser System
Notes: (includes a 1064 handpiece Long-Pulsed Nd;YAG laser); Class II; 9/1/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Beijing Wantai Biological Pharmacy Enterprise Co Ltd
Date Published : 09/16/2009
31 Kexueyuan Road , Changping , Beijing, Beijing CHINA
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: HIV 1 & 2 Rapid Test Kit 2/25/2004. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIV 1 & 2 Rapid Test Kit. 2/25/2004. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Bestview St Limited
Date Published : 10/27/2011
610 Nathan Road Rm 1318-19 Hollywood , Kowloon, CHINA
79 O - - UH Skin resurfacing rf applicator
Date Published: 10/27/2011

Desc: RF Rejuvenation Device
Notes: Class II

89 I - - LX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 10/27/2011

Desc: RF Rejuvenation Device
Notes: Class II

Biobase Biodustry (Shandong)Co., Ltd
Date Published : 06/23/2020
Biobase Biological Industrial Park , Mingshui; Economic Development Zone , Jinan, Shandong CHINA
83 J - - SM Culture Media, Non-Propagating Transport
Date Published: 04/01/2022

Desc: Disposable Virus Sampling Tube Kit- not inactivated

83 J - - SM Culture Media, Non-Propagating Transport
Date Published: 04/01/2022

Desc: VTM Swab Sample Collection Tube Disposable Sampling Tube Kit (Shandong) -not inactivated

83 Q - - BD Microbial nucleic acid storage and stabilization device
Date Published: 04/01/2022

Desc: Disposable Virus Sampling Tube Kit- inactivated

83 Q - - BD Microbial nucleic acid storage and stabilization device
Date Published: 04/01/2022

Desc: VTM Swab Sample Collection Tube Disposable Sampling Tube Kit (Shandong) -Inactive

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 04/01/2022

Desc: 2019-nCoV RT-qPCR Detection Kit (Colloidal Gold)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 04/01/2022

Desc: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/01/2022

Desc: SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

CARDICARE COMPANY LTD.
Date Published : 11/24/2021
Wushan , Hangzhou, Zhejiang CHINA
74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive
Date Published: 11/24/2021

Desc: Single Patient Use Aneroid Sphygmomanometer

74 D - - XQ Cuff, Blood-Pressure
Date Published: 10/27/2023

Desc: Medic-Kit5 EMT Kit

CHANGCHUN WANCHENG BIO ELECTRON
Date Published : 03/12/2021
NO 789 Shunda Road Chan , Changchun, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 03/12/2021

Desc: COVIDEX-AB2

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 03/12/2021

Desc: Biopolygen's COVID-19 Antibody Screening Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/12/2021

Desc: COVIDEX-AB2

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/12/2021

Desc: Biopolygen's COVID-19 Antibody Screening Test

CHONGQING VISION STAR OPTICAL CO
Date Published : 12/18/2020
28-2 5th Street , Hong Caofang Zhengjie, Shapingba , Chongqing, CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

CIMC INTELLIGENT TECHNOLOGY CO LTD
Date Published : 02/09/2021
B218 Shenzhen Softwarepark T3 Building Hitech South Rd Sev , Shenzhen, CHINA
95 R - - HP Uv lamp, germicidal
Date Published: 02/09/2021

Desc: UVC GERMICIDAL LIGHT UVFRESHR MINI

Cardicare Company, LTD
Date Published : 11/24/2021
D Gaochun , 27 Huashanlu; Gaochunxian , Nanjing, Jiangsu CHINA
74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive
Date Published: 11/24/2021

Desc: Single Patient Use Aneroid Sphygmomanometer

74 D - - XQ Cuff, Blood-Pressure
Date Published: 10/27/2023

Desc: Medic-Kit5 EMT Kit

Cellex Inc., Suzhou
Date Published : 06/22/2021
Bldg 16 , Suzhou, Jiangsu CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/10/2022

Desc: qSARS-CoV-2 IgG/IgM Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/04/2022

Desc: Exa SARS- CoV-2 Rapid Antigen Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: Artemis System COVID-19 Antigen Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: Artemis Rapid Antigen Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: qSARS-CoV-2 Antigen Rapid Test

Changchun Wancheng Bio-Electron Co., Ltd.
Date Published : 06/23/2020
Building 4 Floor 5 , No. 388 Huoju Road , Changchun, Jilin CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/23/2020

Desc: COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/11/2021

Desc: nanoMedicina SARS-COV-2 IgM/IgG ANTIBODY RAPID TEST KIT

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/23/2021

Desc: COVIDEX-AB2

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/23/2020

Desc: COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/23/2021

Desc: Biopolygen's COVID-19 Antibody Screening Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/23/2020

Desc: COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)

Changzhou UNIVERSAL MEDICAL EQUIPMENT CO., LTD
Date Published : 08/03/2022
No. 6 Xinxi Road , Xinbei District , Changzhou, Jiangsu CHINA
80 F - - MC Glove, Patient Examination
Date Published: 08/03/2022

Desc: Nitrile Exam Gloves Powder Free Black

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 08/03/2022

Desc: Nitrile Exam Gloves Powder Free Black

China National Agricultural Machinery Import/Export Corp
Date Published : 09/16/2009
26 South Yuetan St , Beijing Cn, CHINA
89 - - - -- Physical Medicine
Date Published: 09/16/2009

Notes: 11/30/1994 Universal Massage Apparatus

Chongqing Derma Optic and Electronic Technique Co., Ltd.
Date Published : 10/24/2013
2F Biological & Biochemical Park , 70# Ke Yuan 4th Road, Hi-Tech Zone , Chongqing, Chongqing CHINA
73 - - - -- Anesthesiology
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

74 - - - -- Cardiovascular
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

76 - - - -- Dental
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

77 - - - -- Ear,Nose And Throat
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

78 - - - -- Gastroenterological & Urological
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

79 - - - -- General & Plastic Surgery
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

80 - - - -- General Hospital/Personal Use
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

84 - - - -- Neurological
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

85 - - - -- Obstetrical & Gynecological
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

86 - - - -- Ophthalmic
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

87 - - - -- Orthopedic
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

89 - - - -- Physical Medicine
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

90 - - - -- Radiology
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

94 - - - -- Ionizing Non-Medical Devices and Components
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

95 - - - -- Light Emitting Non-Device Products
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

96 - - - -- Radio Frequency Emitting Products
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

97 - - - -- Sound Emitting Products
Date Published: 04/29/2016

Notes: Product: Capillus 272 Laser Hair Cap

Chuangyi Health And Beauty Suppl
Date Published : 07/13/2012
75157 Xiazhuang Road , Shenzhen, CHINA
73 - - - -- Anesthesiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

74 - - - -- Cardiovascular
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

76 - - - -- Dental
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

77 - - - -- Ear,Nose And Throat
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

78 - - - -- Gastroenterological & Urological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

79 - - - -- General & Plastic Surgery
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

80 - - - -- General Hospital/Personal Use
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

84 - - - -- Neurological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

85 - - - -- Obstetrical & Gynecological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

86 - - - -- Ophthalmic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

87 - - - -- Orthopedic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

89 - - - -- Physical Medicine
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

90 - - - -- Radiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

Chy Manufacturer Co Ltd
Date Published : 06/05/2013
16b Donghua Garden , Bao And, CHINA
76 N - - UW Stimulator, Muscle, powered, dental
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Electric TENS massager
Notes: class II

84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

84 N - - YN Stimulator, electrical, transcutaneous, for arthritis
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

85 H - - II Stimulator, Vaginal, Muscle, Powered, for Therapeutic Use
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

Come Beauty Co Ltd
Date Published : 09/09/2013
121 Guangyuan West Road, Room 129a 3/F , Guangzhou, CHINA
79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 09/09/2013

Desc: Massager/Vibrator
Notes: Class II

Core Technology Co. Ltd.
Date Published : 08/31/2021
Building C Room 100 , Life Park Rd; Changping District , Beijing, Beijing CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: Coretests COVID-19 IgM/IgG Ab Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: COVID-19 IgM/IgG Ab Test

Creata (Shenzhen) Ltd
Date Published : 01/20/2012
5015 Shennan Road 19f Benyuan Bl , Shenzhen, CHINA
89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 07/13/2012

Desc: Pimple Remover
Notes: Class II

Creative Concepts Manufacturing Ltd
Date Published : 03/27/2015
A No. 50 Longquanbei Road , Ning Hai Dajiahe Town , Ningo City, CHINA
76 N - - OB Unit,Ultraviolet Sanitation/Sterilization(For Toothbrushes),Non-Sterile
Date Published: 03/27/2015

Desc: UV Toothbrush Sanitizer
Notes: Class II

80 K - - YZ Syringe, Irrigating
Date Published: 03/27/2015

Desc: UV Toothbrush Sanitizer
Notes: Class II

Creative Concepts Manufacturing Ltd
Date Published : 03/27/2015
Fengjia Ind Zone Airport Rd , Ningbo Zhejiang, CHINA
76 N - - OB Unit,Ultraviolet Sanitation/Sterilization(For Toothbrushes),Non-Sterile
Date Published: 03/27/2015

Desc: UV Toothbrush Sanitizer
Notes: Class II

80 K - - YZ Syringe, Irrigating
Date Published: 03/27/2015

Desc: UV Toothbrush Sanitizer
Notes: Class II

Creative Concepts Manufacturing Ltd.
Date Published : 03/11/2015
1210-c 12/f Harbour Center Tower 1 , 1 Hok Cheung Street Hung Hom , Kowloon, CHINA
76 N - - OB Unit,Ultraviolet Sanitation/Sterilization(For Toothbrushes),Non-Sterile
Date Published: 03/11/2015

Desc: UV Toothbrush Sanitizer
Notes: Class II

80 K - - YZ Syringe, Irrigating
Date Published: 03/11/2015

Desc: UV Toothbrush Sanitizer
Notes: Class II

DONG RI ELECTRICAL EQUIPMENT COLTD
Date Published : 06/10/2021
Gaobu Caoduncun , Caodun Industrial Area Gaobuzhen , Dongguan, Guangdong CHINA
80 L - - RJ Disinfectant, Medical Devices
Date Published: 06/10/2021

Desc: Lumin LM3000 Household Item Sanitizer and CPAP Accessory Cleaner
Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation.

80 L - - RJ Disinfectant, Medical Devices
Date Published: 06/10/2021

Desc: Lumin LM3000 Household Item UV Sanitizer
Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation.

DONG TAI CITY HUAYI GLOVES CO LTD
Date Published : 02/23/2024
Rm 1606 , Bldg 1 Jian Xia , Beijing, CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Powder Free Nitrile Patient Examination Gloves Blue Color
Notes:                                                                               

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Powder Free Blue Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
Notes:                                                                               

DONG TIAN YANG INDUSTRIAL CO., LTD
Date Published : 08/10/2016
Lishui , Dachong Industrial District Town, Nanhai , Foshan, Guangdong CHINA
79 G - - FE Brush, Dermabrasion
Date Published: 08/10/2016

Desc: Portable Diamond Dermabrasion

79 P - - BX Massager, vacuum, radio frequency induced heat
Date Published: 08/10/2016

Desc: Bipolar RF Skin Rejuvenation System

DONGGUAN ZHANHUI PLASTIC TECHNOLOGY Co Ltd
Date Published : 03/07/2022
No. 66 S 5th St , Dongguan, Guangdong CHINA
80 F - - XX Mask, Surgical
Date Published: 03/07/2022

Desc: N95 Protective Mask

80 L - - YU Accessory, Surgical Apparel
Date Published: 03/07/2022

Desc: N95 Protective Mask

80 M - - SH Respirator, surgical
Date Published: 03/07/2022

Desc: N95 Protective Mask

80 N - - ZJ Respirator, n95, home use
Date Published: 03/07/2022

Desc: N95 Protective Mask

DONGTAI CITY HUAYI GLOVES CO., LTD.
Date Published : 02/23/2024
No. 36 Nanzhuang Road , High-Tech Industrial Development Zone Of , Dongtai, Jiangsu CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Powder Free Blue Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
Notes:                                                                               

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Powder Free Nitrile Patient Examination Gloves Blue Color
Notes:                                                                               

DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD.
Date Published : 01/26/2021
No. 14 Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino-Singapore Tianjin Eco-City , No 2018 Zhongtian Reven , Tianjin, Tianjin CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: 2019-nCoV IgG/IgM Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: RapidCOV IgM/IgG Antibody Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: SARS-CoV-2 IgM/IgG Antibody Test

Da An Gene Co., Ltd. Of Sun Yat-Sen University
Date Published : 01/26/2021
Science Park , No. 19 Xiangshan Road; High & New Technology , Guangzhou, Guangdong CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing)

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: Assurance AB COVID-19 IgM/IgG Rapid Antibody Test

Denjoy Dental Co Ltd
Date Published : 11/21/2016
Bldg A4 F 4 , NO. 229 Guyuan Road , Changsha, Hunan CHINA
76 E - - BZ Activator, Ultraviolet, For Polymerization
Date Published: 11/21/2016

Desc: DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT
Notes: Class II device without a valid 510K

80 K - - YT Light, Examination, Medical, Battery Powered
Date Published: 11/21/2016

Desc: DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT
Notes: Class II device without a valid 510K

Devon Medical Products (Jianagsu) Ltd.
Date Published : 11/01/2021
East Half of 1-2f, Appt D2, Qinfeng , High ;Tech Business Incubator, 1, Qingfe , Nantong, Jiangsu CHINA
79 O - - MP Negative pressure wound therapy powered suction pump
Date Published: 11/01/2021

Desc: ExtriCare 3600 Negative Pressure Wound Therapy Device

Dolma Industry Limited
Date Published : 07/20/2012
No 1016 Shennan Road (E) Futian District , Room 406 Block A Chunhuiyuan , Shenzhen City, CHINA
74 D - - RW Adaptor, Lead Switching, Electrocardiograph
Date Published: 07/20/2012

Desc: Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado)
Notes: class II

86 N - - FH Digitizer, Images, Ophthalmic
Date Published: 07/20/2012

Desc: Iriscope (Iriscopio)
Notes: class II

DongGuan ACE-TEC CO., LTD
Date Published : 08/01/2011
NO. 468 Wushiling , Dalangzhen , Dongguan, Guangdong CHINA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 11/13/2012

Desc: LED Skin Conditioning Kit Compact Light Therapy
Notes: Class II

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 11/13/2012

Desc: LED Skin Conditioning Kit Compact Light Therapy
Notes: Class II

79 O - - HT Light based over-the-counter hair removal
Date Published: 11/13/2012

Desc: LED Skin Conditioning Kit Compact Light Therapy
Notes: Class II

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 11/13/2012

Desc: LED Skin Conditioning Kit Compact Light Therapy
Notes: Class II

89 - - - -- Physical Medicine
Date Published: 08/01/2011

Desc: SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound
Notes: Class II

Dongguan Ageless Health Industrial Ltd. (China)
Date Published : 05/12/2014
Building A1 3rd Floor , Changping Simacun; Madongshen Industrial Area , Dongguan, Guangdong CHINA
74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive
Date Published: 05/12/2014

Desc: Digital Blood Pressure Monitor (Arm & Writst)
Notes: class II

Dongguan City Meizhi Wiring Co., LTD.
Date Published : 08/08/2011
Mange Zone, Dongguan City, Tiantoujiao , Qiaotou Town , Dongguan, CHINA
79 N - - ZY Light, lymphadema reduction, low energy
Date Published: 11/08/2018

Desc: Color Ray Beauty Light Therapy Device
Notes: Class II

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 08/08/2011

Desc: Color Ray Beauty Light Therapy Device
Notes: Class II

Dongguan HCS Electronics Co., Ltd.
Date Published : 07/02/2021
Bldg. 1 Fl. 4 , 1 Tangsha Dadaozhong; Tangxia Town , Dongguan, Guangdong CHINA
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 07/02/2021

Desc: Infrared Thermometer

E-M Medical Treatment And Electron (Suzhou) Co Ltd
Date Published : 09/09/2014
# 18 Chunqiu Road , Huangdaizhen Xiangcheng , Suzhou, Jiangsu CHINA
80 M - - QX Needle, Acupuncture, Single Use
Date Published: 09/09/2014

Desc: Acupuncture Needles
Notes: ***Class II device without a valid 510K DWPE all acupuncture needles, except the following:                                                                                                                                                                                                                                            ***

Eachy Biopharmaceuticals Co., Ltd
Date Published : 10/22/2020
Building F F , 5 , Suzhou, Jiangsu CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/22/2020

Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/22/2020

Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/22/2020

Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/22/2020

Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/22/2020

Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/22/2020

Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/22/2020

Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/22/2020

Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)

Electronic Instrument Factory
Date Published : 03/08/2011
Unknown Street , Beijing Haidian District, Donghua CHINA
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Multiple Electronic Acupunctoscope
Notes: Class III

Excelsior Leather & Plastic Ind. Co., Ltd
Date Published : 02/10/2017
Eastern Industrial , Zone Hung Yip , Zhu Hai City, Guang Dong CHINA
77 J - - YG Curette, Ear
Date Published: 02/10/2017

Desc: Smart Swab
Notes: Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k).

77 J - - YT Pick, Microsurgical Ear
Date Published: 02/10/2017

Desc: Smart Swab
Notes: Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k).

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Date Published : 04/12/2022
No. 1304 Science And Technology Innovation Park, Shajing Dahong , Shenzhen, Guangdong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/12/2022

Desc: SARS-CoV-2 Antigen Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/12/2022

Desc: Covid 19 Antigen Self Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/12/2022

Desc: SARS-CoV-2 Antigen Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/12/2022

Desc: Covid 19 Antigen Self Test Kit

83 Q - - LW COVID-19 test home collection kit devices
Date Published: 04/12/2022

Desc: SARS-CoV-2 Antigen Test Kit

83 Q - - MN COVID-19 Multi-Analyte Antigen Device
Date Published: 04/12/2022

Desc: Covid 19 Antigen Self Test Kit

FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT CO., LTD.
Date Published : 09/02/2020
6th Floor , 38 Lane 2049 , Shanghai, Shanghai CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 09/02/2020

Desc: Rebound Tonometer

86 H - - KY Tonometer, Manual
Date Published: 09/02/2020

Desc: Rebound Tonometer

86 H - - KZ Sterilizer, Tonometer
Date Published: 09/02/2020

Desc: Rebound Tonometer

86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 09/02/2020

Desc: Rebound Tonometer

Foshan Nanhai Donghui
Date Published : 04/05/2013
Rm A 18/F Development Bldeast Huayuan , Foshan, CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 04/05/2013

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 G - - FE Brush, Dermabrasion
Date Published: 04/05/2013

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 01/23/2019

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

Foshan Nanhai Newface Beauty Instrument Technology Co., Ltd.
Date Published : 04/05/2013
Hutougang, Dachong Industrial Zone , Lishui Town, Nanhai Dist., , Foshan, Guangdong CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 04/05/2013

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 G - - FE Brush, Dermabrasion
Date Published: 04/05/2013

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 01/23/2019

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

89 L - - YG Massager, Therapeutic, Manual
Date Published: 01/23/2019

Desc: MC 600 Multi Function Anti Pressure Slimming Machine
Notes: Device Classification Unknown. Some of the indications may be Class I exempt; some may fall under Class II requiring 510(k) notification; some may not have a predicate and may require de novo or PMA. Submission of a 513(g) is recommended so the closest classification can be determined. ; 5/24/2016

Free Flying International Lte
Date Published : 04/18/2014
5/F Bldg 11 Tongfuyu Park Lezh , Shenzhen, CHINA
84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief
Date Published: 04/18/2014

Desc: Massager
Notes: Class II

84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes
Date Published: 04/18/2014

Desc: Massager
Notes: Class II

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 05/30/2019

Desc: Massager
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/18/2014

Desc: Massager
Notes: Class II

Fuangzhou Balstar Machinery Co
Date Published : 11/28/2011
Bldg Guangdong Shop T4163b 4fl A , Tianjian, CHINA
79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Portable High Frequency Spot Remover; JX-006A Massager
Notes: Class II/III

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/28/2011

Desc: Portable High Frequency Spot Remover; JX-006A Massager
Notes: class II/III

89 L - - YG Massager, Therapeutic, Manual
Date Published: 11/28/2011

Desc: Portable High Frequency Spot Remover; JX-006A Massager
Notes: Class II/III

GALLOP BIOLOGICAL PRODUCTS CO LTD
Date Published : 09/16/2009
NO 1901 TONGFANGTONGXIN BUILDING , WENSAN RD , HANGZHOU, Zhejiang CHINA
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 09/16/2009

Notes: 6/5/2009 "Perfectha Derm" Hyaluronic Acid for cosmetic injection.

GEM TECHNOLOGY CO.,LTD
Date Published : 09/05/2017
NO. 20 BOSONG ROAD ZHEN , HENAN, CHINA
91 L - - AF Gas Chromatography, Methamphetamine
Date Published: 09/05/2017

Desc: "Drug Abuse Test" IVD kit
Notes:                                                                                                                                                          The product labeling; for the device; "Device Abuse Test;" appears to be lack adequate directions for use. Device Classification is unknown.

GENIUS CHIP (SHEN ZHEN) LIMITED
Date Published : 01/17/2013
Xuefu Road, Zhongrun Building A303 , Nanshan District , Shenzhen, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/17/2013

Desc: Bodycomfort EMS Abs and Arms
Notes: Class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 01/17/2013

Desc: Bodycomfort EMS Abs and Arms
Notes: class II

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 01/17/2013

Desc: Bodycomfort EMS Abs and Arms
Notes: class II

GENRUI BIOTECH INC
Date Published : 01/10/2022
4-10f Building 3 Geya T , Shenzhen, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/10/2022

Desc: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR)

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/10/2022

Desc: 2019-nCoV IgM/IgG

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/10/2022

Desc: Novel Coronavirus (2019- nCoV)IgG/IgMTest Kit(Colloidal gold)

GOLDSITE DIAGNOSTICS INC
Date Published : 05/14/2021
No. 103c, 503c & 504d, Technology Building & No. 3a & 4a, Technology Building Annex, Zhaoshang Sub-District, N , Shenzhen, Guangdong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: SARS-CoV-2 IgG/IgM Kit

GOLDSITE DIAGNOSTICS INC
Date Published : 05/14/2021
No. 103c, 503c & 504d, Technology Building & No. 3a & 4a, Technology Building Annex, Zhaoshang Sub-District, N , Shenzhen, Guangdong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: SARS-CoV-2 IgG/IgM Kit

GOLDSITE DIAGNOSTICS INC
Date Published : 05/14/2021
No. 103c, 503c & 504d, Technology Building & No. 3a & 4a, Technology Building Annex, Zhaoshang Sub-District, N , Shenzhen, Guangdong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: SARS-CoV-2 IgG/IgM Kit

GUANGZHOU BAIYUN DISTRICT HANDAELECTRONICS FACTOR
Date Published : 06/06/2018
No. 1 Baiyun Distr , Shajing East Road, Taihe Town , Guangzhou, CHINA
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 06/06/2018

Desc: Mole Removal Pen

GUANGZHOU EKAI ELECTRONIC TECHNO
Date Published : 11/30/2022
Building A F/3 , No. 81 Zijing Street , Guangzhou, Guangdong CHINA
79 Q - - AI Powered microneedle device
Date Published: 11/30/2022

Desc: Hydra Roller

79 Q - - AI Powered microneedle device
Date Published: 11/30/2022

Desc: Microneedle

79 Q - - AI Powered microneedle device
Date Published: 11/30/2022

Desc: Hydra Pen

79 Q - - AI Powered microneedle device
Date Published: 11/30/2022

Desc: Meso Pen

79 Q - - AI Powered microneedle device
Date Published: 11/30/2022

Desc: Microneedle Pen

79 Q - - AI Powered microneedle device
Date Published: 11/30/2022

Desc: Hydra Needle

79 Q - - AI Powered microneedle device
Date Published: 11/30/2022

Desc: Derma Pen

80 K - - YZ Syringe, Irrigating
Date Published: 11/30/2022

Desc: Hydra Needle

80 K - - YZ Syringe, Irrigating
Date Published: 11/30/2022

Desc: Derma Pen

80 K - - YZ Syringe, Irrigating
Date Published: 11/30/2022

Desc: Meso Pen

80 K - - YZ Syringe, Irrigating
Date Published: 11/30/2022

Desc: Microneedle Pen

80 K - - YZ Syringe, Irrigating
Date Published: 11/30/2022

Desc: Hydra Roller

80 K - - YZ Syringe, Irrigating
Date Published: 11/30/2022

Desc: Hydra Pen

80 K - - YZ Syringe, Irrigating
Date Published: 11/30/2022

Desc: Microneedle

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/30/2022

Desc: Hydra Roller

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/30/2022

Desc: Meso Pen

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/30/2022

Desc: Hydra Needle

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/30/2022

Desc: Derma Pen

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/30/2022

Desc: Microneedle

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/30/2022

Desc: Hydra Pen

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/30/2022

Desc: Microneedle Pen

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/30/2022

Desc: Derma Pen

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/30/2022

Desc: Microneedle

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/30/2022

Desc: Meso Pen

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/30/2022

Desc: Microneedle Pen

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/30/2022

Desc: Hydra Pen

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/30/2022

Desc: Hydra Needle

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/30/2022

Desc: Hydra Roller

89 K - - NM Device, Pressure Applying
Date Published: 11/30/2022

Desc: Microneedle

89 K - - NM Device, Pressure Applying
Date Published: 11/30/2022

Desc: Meso Pen

89 K - - NM Device, Pressure Applying
Date Published: 11/30/2022

Desc: Hydra Roller

89 K - - NM Device, Pressure Applying
Date Published: 11/30/2022

Desc: Derma Pen

89 K - - NM Device, Pressure Applying
Date Published: 12/13/2022

Desc: Microneedle Pen

89 K - - NM Device, Pressure Applying
Date Published: 11/30/2022

Desc: Hydra Needle

89 K - - NM Device, Pressure Applying
Date Published: 11/30/2022

Desc: Hydra Pen

89 L - - YG Massager, Therapeutic, Manual
Date Published: 11/30/2022

Desc: Microneedle Pen

89 L - - YG Massager, Therapeutic, Manual
Date Published: 11/30/2022

Desc: Meso Pen

89 L - - YG Massager, Therapeutic, Manual
Date Published: 11/30/2022

Desc: Hydra Roller

89 L - - YG Massager, Therapeutic, Manual
Date Published: 11/30/2022

Desc: Hydra Pen

89 L - - YG Massager, Therapeutic, Manual
Date Published: 11/30/2022

Desc: Derma Pen

89 L - - YG Massager, Therapeutic, Manual
Date Published: 11/30/2022

Desc: Hydra Needle

89 L - - YG Massager, Therapeutic, Manual
Date Published: 11/30/2022

Desc: Microneedle

GUANGZHOU FENGHUA BIOENGINEERING CO.,LTD.
Date Published : 07/17/2020
Guangzhou Economic And Technological , No. 6 Yinyi Street; Development District , Guangzhou, Guangdong CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit

GUANGZHOU GD BEAUTY EQUIPMENT
Date Published : 08/22/2017
Pengshang Industrial Areapengshang Zhifu Road , Guangzhou, Guangdong CHINA
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/22/2017

Desc: Colorful LED Beauty Mask
Notes: Class II device without a valid 510K

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 08/22/2017

Desc: Colorful LED Beauty Mask
Notes: Class II device without a valid 510K

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 08/22/2017

Desc: Colorful LED Beauty Mask
Notes: Class II device without a valid 510K

GUANGZHOU MECAN MEDICAL LTD
Date Published : 09/02/2020
RM 718, YIDONG BLDG., X , GUANGZHOU, CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 09/02/2020

Desc: Rebound Tonometer

86 H - - KY Tonometer, Manual
Date Published: 09/02/2020

Desc: Rebound Tonometer

86 H - - KZ Sterilizer, Tonometer
Date Published: 09/02/2020

Desc: Rebound Tonometer

86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 09/02/2020

Desc: Rebound Tonometer

GUANGZHOU RUIMEI TECHNOLOGY CO. LTD.
Date Published : 07/11/2011
Hengsheng Building B, Huanshi Room 1019 , No. 25 Zhong Road; Yuexiu District , Guangzhou, CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 04/05/2013

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 G - - FE Brush, Dermabrasion
Date Published: 07/11/2011

Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine
Notes: Class II

79 G - - FE Brush, Dermabrasion
Date Published: 07/11/2011

Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine
Notes: Class II

79 G - - FE Brush, Dermabrasion
Date Published: 07/11/2011

Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine
Notes: Class II

79 G - - FE Brush, Dermabrasion
Date Published: 07/11/2011

Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine
Notes: Class II

79 G - - FE Brush, Dermabrasion
Date Published: 04/05/2013

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 G - - FE Brush, Dermabrasion
Date Published: 07/11/2011

Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System
Notes: Class II

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine
Notes: Class II

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine
Notes: Class II

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System
Notes: Class II

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine
Notes: Class II

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine
Notes: Class II

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 07/11/2011

Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System
Notes: Class II

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 07/11/2011

Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine
Notes: Class II

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 07/11/2011

Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine
Notes: Class II

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 07/11/2011

Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine
Notes: Class II

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 07/11/2011

Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine
Notes: Class II

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 01/23/2019

Desc: Facial Beauty Machine
Notes: Class II; 4/5/2013

89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 07/11/2011

Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine
Notes: Class II

89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 07/11/2011

Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine
Notes: Class II

89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 07/11/2011

Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine
Notes: Class II

89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 07/11/2011

Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine
Notes: Class II

89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 07/11/2011

Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System
Notes: Class II

GUAUNGZHOU KONMISON ELECTRONIC TECHNOLOGY CO., LIMITED
Date Published : 03/27/2023
Room 205 , Building No.2, Rich Plaza, No.7, Nanzhuang Road,Yongping Street, Baiyun District, Guangzhou City , Guangzhou, Guangdong CHINA
73 P - - CM Portable liquid oxygen unit stand
Date Published: 03/27/2023

Desc: OXYGENATING INFUSION
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

79 G - - FE Brush, Dermabrasion
Date Published: 03/27/2023

Desc: 5-in-1 Dermal Reset Beauty Optimization
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 03/27/2023

Desc: 5-in-1 Dermal Reset Beauty Optimization
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 03/27/2023

Desc: LIGHT FREQUENCY THERAPY
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 03/27/2023

Desc: 5-in-1 Dermal Reset Beauty Optimization
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 03/27/2023

Desc: LIGHT FREQUENCY THERAPY
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction
Date Published: 03/27/2023

Desc: RADIOFREQUENCY STIMULATION
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction
Date Published: 03/27/2023

Desc: 5-in-1 Dermal Reset Beauty Optimization
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

79 Q - - AI Powered microneedle device
Date Published: 03/27/2023

Desc: 5-in-1 Dermal Reset Beauty Optimization
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

79 Q - - AI Powered microneedle device
Date Published: 03/27/2023

Desc: DERMAL NEEDLING ENHANCER
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/27/2023

Desc: 5-in-1 Dermal Reset Beauty Optimization
Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

Gaodin Medical Shanghai Co Ltd
Date Published : 12/18/2020
# 1004 Rong Xin Buidling No.1851north , Shanghai, Shanghai CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

Gatoson Holdings Ltd (The)
Date Published : 09/16/2009
One International Finance Centre,18th FL , 1 Harbour View Street, Central , Hong Kong, CHINA
74 D - - XY Pulse-Generator, Pacemaker, Implantable
Date Published: 01/23/2019

Desc: Pulse Generator; Pacemaker Implantable
Notes: Class III; 4/14/2003

Gemc Techonology
Date Published : 02/29/2016
NO. 20 Bosong Lu , Jinshui , Zhengzhou, Henan CHINA
75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter
Date Published: 02/29/2016

Desc: Pregnancy Test Kits

Genrui Biotech Inc
Date Published : 04/15/2021
B , 1183 Liuxiandadao Liuxian Dasha; Nanshanblvd , Shenzhen, Guangdong CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/10/2022

Desc: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR)

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/15/2021

Desc: 2019-nCoV IgM/IgG

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/15/2021

Desc: Novel Coronavirus(2019-nCoV)IgG/IgM Test Kit(Colloidal gold)

Getein Biotech Inc.
Date Published : 07/07/2020
No. 9 Bofu Road , Luhe District , Nanjing, Jiangsu CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/07/2020

Desc: One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/07/2020

Desc: One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/07/2020

Desc: One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)

Guangdong Ardent Biomed Co., Ltd
Date Published : 06/08/2022
High-Tech Industrial 4th Floor , Of C1 Building,No.11 Kaiyuan Road Science City; Development District , Guangzhou, Guangdong CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit(PCR fluorescent Probe)

Guangdong Haiou Medical Apparatus Co., Ltd
Date Published : 04/30/2021
Nanyuan Industrial , Zone, North Liusha , Puning, Guangdong CHINA
80 M - - EG Syringe, Antistick
Date Published: 04/30/2021

Desc: Disposable sterile needle retractable safety syringe 1mL 25G x 1inch (25mm)
Notes: Needle Retractable Safety Syringe; model 1mL 25G x 1inch (25mm) dimensions subject to DWPE

80 M - - EG Syringe, Antistick
Date Published: 04/30/2021

Desc: Disposable sterile needle retractable safety syringe 1mL 23G x 1inch (25mm)
Notes: Needle Retractable Safety Syringe; model 1mL 23G x 1inch (25mm) dimensions subject to DWPE

Guangzhou Aillx Rubber Product Co., Ltd
Date Published : 08/19/2012
Jin Lai Mansion, No 799 San Yuan Li Dao , Guangdong, CHINA
85 H - - IS Condom
Date Published: 08/19/2012

Desc: Condoms
Notes: Class II

85 L - - TZ Condom With Nonoxynol-9
Date Published: 08/19/2012

Desc: Condoms
Notes: Class II

Guangzhou April Face Beauty LTD
Date Published : 07/28/2022
GUANGZHOUSH YUEXIUQU JIANSHE DAMALU 22 HAO B DONG 3308 SHI CHINA , DAMALU 22, HAO 8 DONG CHINA
89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 07/28/2022

Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber
Notes: For over the counter (OTC) use

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 07/28/2022

Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin
Notes: For over the counter (OTC) use

89 I - - MB Cabinet, Moist Steam
Date Published: 07/28/2022

Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin
Notes: For over the counter (OTC) use

89 I - - MB Cabinet, Moist Steam
Date Published: 07/28/2022

Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber
Notes: For over the counter (OTC) use

89 I - - OB Lamp, Infrared, Physical Medicine
Date Published: 07/28/2022

Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber
Notes: For over the counter (OTC) use

89 I - - OB Lamp, Infrared, Physical Medicine
Date Published: 07/28/2022

Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin
Notes: For over the counter (OTC) use

89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy
Date Published: 07/28/2022

Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin
Notes: For over the counter (OTC) use

89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy
Date Published: 07/28/2022

Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber
Notes: For over the counter (OTC) use

Guangzhou Beco Electronic
Date Published : 10/30/2013
113 Nan Highway , Guangzhou, Guangdong CHINA
79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Laser Lipolysis device
Notes: class II

79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager
Date Published: 10/30/2013

Desc: Laser Lipolysis device
Notes: class II

79 O - - RK Laser assisted lipolysis
Date Published: 10/30/2013

Desc: Laser Lipolysis device
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/30/2013

Desc: Laser Lipolysis device
Notes: class II

Guangzhou Bio-curve Beauty & Health Equipment
Date Published : 12/21/2010
No 2 Workshop Lianyuan Roadsecond Rd , Guangzhouguangzhou, CHINA
87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 06/04/2019

Desc: Massage Ultrasound Equipment
Notes: Class III ;

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 06/04/2019

Desc: Therapeutic Skin Ultrasound Devices
Notes: Class III ;

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 12/21/2010

Desc: Massage Ultrasound Equipment
Notes: Class III

89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 12/21/2010

Desc: Massage Ultrasound Equipment
Notes: Class III

89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 12/21/2010

Desc: Therapeutic Skin Ultrasound Devices
Notes: Class III

Guangzhou Cnsipot Co., Ltd
Date Published : 06/25/2015
C204-205, Hetai Plastic Materail Agora , Hetai Road; Baiyun District , Guangzhou, Guangdong CHINA
90 I - - WI Source, Isotope, Sealed, Gold, Titanium, Platinum
Date Published: 06/25/2015

Desc: Scalar Energy Pendants
Notes: Class II

90 K - - XK Source, Brachytherapy, Radionuclide
Date Published: 06/25/2015

Desc: Scalar Energy Pendants
Notes: Class II

Guangzhou Fortunique Limited
Date Published : 08/15/2018
Building 4 , No. 202 Shiyulu; Fanyu , Guangzhou, Guangdong CHINA
80 M - - MP Cover, Barrier, Protective
Date Published: 08/15/2018

Desc: Probe Cover; ultrasound
Notes: Class II device without a valid 501K. For PC 80MMP; only ultrasound probe covers are subject to DWPE under this listing.

90 I - - TX Transducer, Ultrasonic, Diagnostic
Date Published: 08/15/2018

Desc: Probe Cover; ultrasound
Notes: Class II device without a valid 501K.

Guangzhou Health And Medical Equipment Co Ltd
Date Published : 10/17/2013
1000 Xin Gang East Rd , Guangzhou, Guangdong CHINA
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 10/17/2013

Desc: Electrostatic Field Therapy Device
Notes: Class II

84 N - - YN Stimulator, electrical, transcutaneous, for arthritis
Date Published: 10/17/2013

Desc: Electrostatic Field Therapy Device
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/17/2013

Desc: Electrostatic Field Therapy Device
Notes: Class II

Guangzhou Hua Nan Medical Apparatus & Instruments Co., Ltd.
Date Published : 01/23/2019
212 Xingang W. Road , Guangzhou, CHINA
89 - - - -- Physical Medicine
Date Published: 01/23/2019

Desc: Positive/Negative Pressure Integrated Computer Control Augmented Sequential External Counter-Pulsation Devices
Notes: 2/24/1998

Guangzhou Inkue Technology Co Ltd
Date Published : 11/01/2012
Floor 3 Tower A, Fengsheng Industry , Guangzhou, CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 11/01/2012

Desc: Skin Scrubber Beauty Machine
Notes: class II

79 G - - FE Brush, Dermabrasion
Date Published: 11/01/2012

Desc: Skin Scrubber Beauty Machine
Notes: class II

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 11/01/2012

Desc: Skin Scrubber Beauty Machine
Notes: Class II

Guangzhou Jian Yuan Electronics Co. Ltd.
Date Published : 12/11/2013
Building No. Floor 6 , 14 Dashi Street; Fanyuindust , Guangzhou, Guangdong CHINA
80 M - - QX Needle, Acupuncture, Single Use
Date Published: 12/11/2013

Desc: Micro Needle Skin Roller
Notes: class II

Guangzhou Jimy Facial
Date Published : 01/21/2015
64 Hengzhigang Rd , Guangzhou, CHINA
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 01/21/2015

Desc: Skin Resurfacer

79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager
Date Published: 01/21/2015

Desc: Skin Resurfacer

79 O - - UH Skin resurfacing rf applicator
Date Published: 01/21/2015

Desc: Skin Resurfacer

Guangzhou Jimy Facial & Hair Beauty Products CO., LTD
Date Published : 08/14/2012
Dasha Village Industrial Park , Huangqi Town, Nanhai District , Foshan City, Guandong CHINA
73 - - - -- Anesthesiology
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

74 - - - -- Cardiovascular
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

76 - - - -- Dental
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

77 - - - -- Ear,Nose And Throat
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

78 - - - -- Gastroenterological & Urological
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

79 - - - -- General & Plastic Surgery
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

80 - - - -- General Hospital/Personal Use
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

84 - - - -- Neurological
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

85 - - - -- Obstetrical & Gynecological
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

86 - - - -- Ophthalmic
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

87 - - - -- Orthopedic
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

89 - - - -- Physical Medicine
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

90 - - - -- Radiology
Date Published: 08/14/2012

Notes: All device products; Class I, II, III

Guangzhou Junguan Beauty Co., Ltd.
Date Published : 10/02/2015
Booth T02 First Floor , No 121 Guangyuan West Rd; Meibo City , Guangzhou, Guangdong CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 10/02/2015

Desc: Micro Needle Roller
Notes: Class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 10/02/2015

Desc: Micro Needle Roller
Notes: Class II

Guangzhou Konmison Electronic Technology Co., Limited
Date Published : 02/21/2018
Guangyi Business Center E-202 , Baiyun Avenue North 86 Baiyun , Guangzhou, Guangdong CHINA
79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 02/21/2018

Desc: Cold Pack and Vibrating Massager
Notes:                                                        

79 O - - LI Fat Reducing Low Level Laser
Date Published: 02/21/2018

Desc: Cold Pack and Vibrating Massager
Notes:                                                        

79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager
Date Published: 02/21/2018

Desc: Cold Pack and Vibrating Massager
Notes:                                                        

79 P - - BX Massager, vacuum, radio frequency induced heat
Date Published: 02/21/2018

Desc: Cold Pack and Vibrating Massager
Notes:                                                        

79 P - - KT Laser for disruption of adipocyte cells for aesthetic use
Date Published: 02/21/2018

Desc: Cold Pack and Vibrating Massager
Notes:                                                        

89 P - - HW Cold pack and vibrating massager
Date Published: 02/21/2018

Desc: Cold Pack and Vibrating Massager
Notes:                                                        

Guangzhou Merican Optoelectronic Technology Co., Ltd.
Date Published : 04/07/2023
Building A Yimei Ind District , No 8 Fuyuan 3rd Road Jignhu Street , Huadu District, CHINA
79 R - - EF Suntan bed
Date Published: 04/07/2023

Desc: Tanning Bed

Guangzhou Minsheng Electronic Technical Co., Ltd.
Date Published : 11/03/2016
No. 8 Fenghe Road , Renhezhen Baiyun , Guangzhou, Guangdong CHINA
90 M - - UJ System, Planning, Radiation Therapy Treatment
Date Published: 11/03/2016

Desc: Dr. Fargo Photon Energy Detoxification Bag
Notes: Class II Device (may be a Class III). The device claims made are varied and the mechanism of technology of the device is and it is unclear how the device produces the intended effects are unclear. CDRH is not aware of any predicate devices that the manufacturer may compare to for 510(k) submission. Therefore; there is no specific product code or regulation that applies to this device since there are no known predicate device(s).

Guangzhou Nouzi Beauty Equipment Co Ltd
Date Published : 08/13/2013
No.23 Ziyuan Street , Guangzhou, CHINA
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 08/13/2013

Desc: Body Relaxing Machine (weight loss device)
Notes: Class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 08/13/2013

Desc: Body Relaxing Machine (weight loss device)
Notes: Class II

89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Date Published: 08/13/2013

Desc: Body Relaxing Machine (weight loss device)
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 08/13/2013

Desc: Body Relaxing Machine (weight loss device)
Notes: Class II

Guangzhou Sange Electronic Co., Ltd
Date Published : 06/23/2010
No 7. Shajingbei East Rd.Yongxing Tajhe, , Baijun District , Guangzhou, CHINA
80 - - - -- General Hospital/Personal Use
Date Published: 11/08/2018

Desc: Detoxification Food Spa

Guangzhou Wadami Beauty Equipment Co Ltd
Date Published : 10/03/2013
330 Guangcong First Road , Baiyun Dist , Guangzhou, Guangdong CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 10/03/2013

Desc: Derma (Body) Roller
Notes: Class II Device

79 G - - EF Applier, Staple, Surgical
Date Published: 10/03/2013

Desc: Derma (Body) Roller
Notes: Class II Device

79 M - - DM Instrument, Manual, General Surgical
Date Published: 10/03/2013

Desc: Derma (Body) Roller
Notes: CLASS II Device

89 L - - YG Massager, Therapeutic, Manual
Date Published: 10/03/2013

Desc: Derma (Body) Roller
Notes: Class II Device

Guangzhou Wondfo Biotech Co., Ltd.
Date Published : 04/20/2022
501 Rom, 5F Self-edited Building 1, , No. 8 Lizhishan Road; Science City Huangpu District , Guangzhou, Guangdong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2022

Desc: Wondfo SARSCoV-2 Antibody Test (Lateral Flow Method

Guangzhou Xinbo Electronic Co., Ltd
Date Published : 12/18/2020
2nd Building Juntuo Industry Parkxinye , Panyu , Guangzhou, Guangdong CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

Guangzhou Xiubo Medical Equipment Co. Ltd
Date Published : 04/06/2017
No. 22 Tian Yuan Road, Baiyun District , Guangzhou, Guangdong CHINA
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 04/06/2017

Desc: OTESALY Cross-linked Hyaluronic Acid w/lidocaine
Notes: Class III device without a premarket approval (PMA)

87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 04/06/2017

Desc: OTESALY Cross-linked Hyaluronic Acid w/lidocaine
Notes: Class III device without a premarket approval (PMA)

Guangzhou Yuanfan Co. Ltd
Date Published : 03/08/2013
Jiefangxi Road 128 , Panyu , Guangzhou City, Guangdong CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 03/08/2013

Desc: Derma Stamp Electric Pen
Notes: Class II

79 G - - FE Brush, Dermabrasion
Date Published: 03/08/2013

Desc: Derma Stamp Electric Pen
Notes: Class II

79 O - - UH Skin resurfacing rf applicator
Date Published: 03/08/2013

Desc: Derma Stamp Electric Pen
Notes: class II

Guangzhou Zhuoxin Biological Engineering Co., Ltd
Date Published : 03/24/2011
F 1-3 , # 128 East Ring Rd; Pan Yu District , Guangzhou, Guangdong CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/24/2011

Desc: Manual Therapeutic Massager

89 L - - YG Massager, Therapeutic, Manual
Date Published: 03/24/2011

Desc: Manual Therapeutic Massager
Notes: Class III

Guangzhu Bester Beauty Equipment Co., Ltd
Date Published : 03/26/2013
Mid Building N. 23 Tianfengplaza # , 141 Baiyun Roadnue No , Guangzhou, Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 03/26/2013

Notes: All Devices; Class II

74 - - - -- Cardiovascular
Date Published: 03/26/2013

Notes: All Devices; Class II

76 - - - -- Dental
Date Published: 03/26/2013

Notes: All Devices; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 03/26/2013

Notes: All Devices; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 03/26/2013

Notes: All Devices; Class II

79 - - - -- General & Plastic Surgery
Date Published: 03/26/2013

Notes: All Devices; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 03/26/2013

Notes: All Devices; Class II

84 - - - -- Neurological
Date Published: 03/26/2013

Notes: All Devices; Class II

85 - - - -- Obstetrical & Gynecological
Date Published: 03/26/2013

Notes: All Devices; Class II

86 - - - -- Ophthalmic
Date Published: 03/26/2013

Notes: All Devices; Class II

87 - - - -- Orthopedic
Date Published: 03/26/2013

Notes: All Devices; Class II

89 - - - -- Physical Medicine
Date Published: 03/26/2013

Notes: All Devices; Class II

90 - - - -- Radiology
Date Published: 03/26/2013

Notes: All Devices; Class II

HANDSOME INDUSTRIAL (H.K.) CO., LTD
Date Published : 09/04/2013
No. 155, Xinhua Rd., Hudua District , Guongzhou , Guangdong, GUANGDONG CHINA
79 M - - DM Instrument, Manual, General Surgical
Date Published: 09/04/2013

Desc: Microneedle roller
Notes: class III

88 K - - JB Apparatus, Roller
Date Published: 09/04/2013

Desc: Microneedle roller
Notes: Class III

HANGZHOU LAIHE BIOTECH CO,. LTD.
Date Published : 05/28/2021
No.2b Building 1st Floor Room 505-512 , No. 688 Bin'An Road, Changhe Jiedao; Binjiang District , Hangzhou, Zhejiang CHINA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/28/2021

Desc: QuickKit Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold Method)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/04/2022

Desc: LYHER Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)

HANGZHOU REALY TECH CO LTD
Date Published : 10/19/2020
Zhi Jiang Ming Lou #12 4th Flr , Eastern Medicine; Jianggan , Hangzhou, Zhejiang CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/19/2020

Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/19/2020

Desc: 2019nCOV IgG/IgM Rapid Test

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/19/2020

Desc: Realy New Coronavirus Covid19 Rapid test

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/19/2020

Desc: Realy New Coronavirus Covid19 Rapid test

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/19/2020

Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/19/2020

Desc: 2019nCOV IgG/IgM Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/19/2020

Desc: 2019nCOV IgG/IgM Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/19/2020

Desc: Realy New Coronavirus Covid19 Rapid test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/19/2020

Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/19/2020

Desc: Realy New Coronavirus Covid19 Rapid test

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/19/2020

Desc: 2019nCOV IgG/IgM Rapid Test

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/19/2020

Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device

HANGZHOU TESTSEA BIOTECHNOLOGY CO LTD
Date Published : 06/23/2020
No.13 , 2 Guanshan Road; Pingyaozhen Yuhang , Hangzhou, Zhejiang CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/23/2020

Desc: One Step SARS-CoV2(COVID-19) IgG/IgM Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/23/2020

Desc: One Step SARS-CoV2(COVID-19) IgG/IgM Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/25/2021

Desc: TESTSEALABS Covid-19 IgG/IgM Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/25/2021

Desc: SARS-CoV-2 IgG/IgM Test Cassette

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/23/2020

Desc: One Step SARS-CoV2(COVID-19) IgG/IgM Test

HANGZHOU ZHEDA DIXUN BIOLOGICAL
Date Published : 03/02/2021
2 No 568 Binkang Rd Bi , Hangzhou, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 03/02/2021

Desc: QuickZen COVID-19 IgM / IgG

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/02/2021

Desc: QuickZen COVID-19 IgM / IgG

HUBEI JUNYAN MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
Date Published : 09/12/2022
No. 397 Lukou Rd , Huangzhou District , Huanggang, Hubei CHINA
79 F - - RO Dressing
Date Published: 09/12/2022

Desc: Adhesive tape

79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/12/2022

Desc: Adhesive tape

HUNAN RUNKUN PHARMACEUTICAL CO
Date Published : 06/23/2020
Bld B Zhantao Tech Zhi , Hong Kong, CHINA
83 G - - NX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)

HUNAN RUNMEI GENE TRCHNOLOGY COLTD
Date Published : 11/24/2021
Rm 401 Bldg 3 1048 Zhong Qing Road , Hunan, Hunan CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: New Coronavirus COVID-19 Nucleic Acid Dectection Kit (Fluorescent RT-PCR- Method)

Haci Co Ltd
Date Published : 03/24/2016
No 169 Tongxiang St , Harbin, CHINA
84 M - - VV Device, Acupressure
Date Published: 03/24/2016

Desc: Magnetic Acupressure Suction Cup

Haimen Shengbang Laboratory Equipment Co. Ltd.
Date Published : 08/19/2021
D, Sanhe , No. 50 Xue Qian Road; Sanhezhen Haimen , Nantong, Jiangsu CHINA
80 N - - NI Container, Specimen, Non-Sterile
Date Published: 10/06/2021

Desc: Disposable Virus Specimen Collection Tube

83 J - - SG Culture Media, Non-Selective And Non-Differential
Date Published: 08/04/2022

Desc: Viral Transport Tube; Type HX-K59; HX-K60; HX-K61

83 J - - SM Culture Media, Non-Propagating Transport
Date Published: 08/19/2021

Desc: Viral Transport Media; Type HX-K59; HX-K60; HX-K61

83 J - - SM Culture Media, Non-Propagating Transport
Date Published: 08/19/2021

Desc: Viral Transport Tube; Type HX-K59; HX-K60; HX-K61

83 Q - - MC Transport medium, notified per the VTM guidance
Date Published: 08/19/2021

Desc: Viral Transport Media; Type HX-K59; HX-K60; HX-K61

83 Q - - MC Transport medium, notified per the VTM guidance
Date Published: 08/19/2021

Desc: Viral Transport Tube; Type HX-K59; HX-K60; HX-K61

88 K - - JG Tube, Tissue Culture
Date Published: 08/04/2022

Desc: Virus Collection Tube Kit

Hangzhou AllTest Biotech Co.,Ltd
Date Published : 01/26/2021
No. 550 Yinhai Street , Hangzhou Economic & Technological Area , Hangzhou, Zhejiang CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: COVID IgG/IgM Rapid Test Strip

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: 2019-NCOV IGG/IGM RAPID TEST CASSETTE

Hangzhou Ausia Biological Tech. Co., Ltd
Date Published : 02/03/2012
No. 1 First Rd, Hetz , Hangzhou, Zhejiang CHINA
82 M - - ZF Test, HIV Detection
Date Published: 02/03/2012

Desc: HIV test kit
Notes: class II

Hangzhou Biotest Biotech Co.,Ltd.
Date Published : 08/30/2021
# 17 Zhong Tai Lu , Yuhangqu , Hangzhou City, Zhejiangsheng CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: NADAL COVID-19 IgG/IgM Test

Hangzhou Clongene Biotech Co., Ltd.
Date Published : 09/02/2020
No. 1 Yuchang Road , Yuhang , Hangzhou, Zhejiang CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/02/2020

Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/19/2022

Desc: CLUNGENE COVID-19 IgG/IgM Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/19/2022

Desc: CLUNGENE SARSCOV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/02/2020

Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/02/2020

Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette

Hangzhou Clongene Biotech Co., Ltd.
Date Published : 06/23/2020
No. 1 Yuchang Road , Yuhang , Hangzhou, Zhejiang CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/23/2020

Desc: COMBRA COVID-19 IgM/IgG Rapid Test Cassette

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/02/2020

Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/23/2020

Desc: COMBRA COVID-19 IgM/IgG Rapid Test Cassette

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/02/2020

Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/23/2020

Desc: COMBRA COVID-19 IgM/IgG Rapid Test Cassette

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/02/2020

Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette

Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
Date Published : 08/31/2021
Hangzhou Economic , No. 139 10th Street (East); Technology Development Zone , Hangzhou, Zhejiang CHINA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 08/31/2021

Desc: KaiBiLi COVID-19 Antigen Rapid Test Device

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 08/31/2021

Desc: AntiCHEK SARS-CoV-2 (COVID-19) Rapid Antigen Test

Hangzhou Singclean Medical Products Co Ltd
Date Published : 04/28/2017
No 125 (E) 10th Street, Hangzhoui , Economic & Technological Development Zon , Hangzhou, Zhejiang CHINA
53 P H - 99 Other Cosmetic Raw Materials, N.E.C., Powder
Date Published: 04/28/2017

Desc: Singfiller Cross-linked Sodium Hyaluronate Gel
Notes: Class III device without a PMA

53 P Y - 99 Other Cosmetic Raw Materials, N.E.C., Not Elsewhere Classified (NEC)
Date Published: 04/28/2017

Desc: Singfiller Cross-linked Sodium Hyaluronate Gel
Notes: Class III device without a PMA

78 M - - RE Solution, Sodium Hyaluronate
Date Published: 06/04/2019

Desc: SINGFILLER ANTI-AGING GEL
Notes: Class III device without a PMA

78 M - - RE Solution, Sodium Hyaluronate
Date Published: 04/28/2017

Desc: Singfiller Cross-linked Sodium Hyaluronate Gel
Notes: Class III device without a PMA

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 06/04/2019

Desc: SINGFILLER ANTI-AGING GEL
Notes: Class III device without a PMA

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 04/28/2017

Desc: Singfiller Cross-linked Sodium Hyaluronate Gel
Notes: Class III device without a PMA

Hanson Meditechh
Date Published : 09/16/2009
Shui Wei Tang, Along Celebrates Area , Lotus Pond Road # 167 , Nanchong, Sichuan CHINA
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: 2/16/2007 HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: 2/16/2007 HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Health Herald
Date Published : 06/05/2013
Nanchang, Gushu , Xi'Xiang Town, Bao'an District , Shenzhen, CHINA
76 N - - UW Stimulator, Muscle, powered, dental
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Electric TENS massager
Notes: class II

84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

84 N - - YN Stimulator, electrical, transcutaneous, for arthritis
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

85 H - - II Stimulator, Vaginal, Muscle, Powered, for Therapeutic Use
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 06/05/2013

Desc: Electric TENS massager
Notes: class II

Hk Camaz Industry Limited
Date Published : 12/14/2015
Block B Guangzhou Office Rm 203-205 , Aiyun , Guanghzou, CHINA
79 M - - DM Instrument, Manual, General Surgical
Date Published: 12/14/2015

Desc: Quartz Crystal Pens

Hong Kung King Lim International In
Date Published : 12/14/2011
No 52 Shijia Rdjunhe St Baiyum , Guamgzhou Cityguamgzhou City, CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 12/14/2011

Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

79 G - - FE Brush, Dermabrasion
Date Published: 12/14/2011

Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon ;

89 I - - SA Massager, Therapeutic, Electric
Date Published: 12/14/2011

Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon

97 R - - AF Cleaner, Ultrasonic Non-Medical Devices
Date Published: 12/14/2011

Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon & Ultrasonic) ;

Hongkong Phenitech Co Ltd
Date Published : 04/07/2013
NO 2709 West Towercoast Kafunuo Bldg No , Shenzhenshenzhen, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/07/2013

Desc: Digital Therapy Machine Tens Unit
Notes: Class II

Hsin Ten Health & Wealth Industry (Hefei) Co., Ltd.
Date Published : 09/16/2009
669 Changjiangxilu , Hefei, Anhui CHINA
89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 09/16/2009

Notes: 4/20/2000 Health Builder

89 I - - OB Lamp, Infrared, Physical Medicine
Date Published: 09/16/2009

Notes: Hothouse FIR Health Builder 11/26/2001

Hunan Runkun Pharmaceutical Co., Ltd
Date Published : 06/23/2020
N0.380 Baling East Road, Economic-Technological Development Zone , Yueyang, Hunan CHINA
83 G - - NX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/23/2020

Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)

IDT DIAGNOSTICS CC
Date Published : 05/28/2021
271 De Goede Hoop , Noordhoek, CHINA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/28/2021

Desc: COVID-19 Antigen

Innovita Tangshan Biological Technology Co Ltd
Date Published : 06/22/2021
High-Tech Ind , No 699 Juxin Street; Dev Zone , Qian'An, Hebei CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: Scanwell SARS-CoV-2 IgM & IgG Test System

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: Innovita 2019-nCoV Ag Test (Latex Chromatography Assay)

Intec Products, Inc. (Xiamen)
Date Published : 05/12/2014
332 Xinguang Road , Industrial Areafujian Prov , Xiamen, Fujian CHINA
81 M - - TK Kit, Sample Collection, HIV
Date Published: 05/12/2014

Desc: HIV Home Test Kit
Notes: Class III

JIANGSU COWIN BIOTECH CO LTD
Date Published : 12/07/2021
East Of Lujia Road , Pharmaceutical City Of , Taizhou, Jiangsu CHINA
83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 12/07/2021

Desc: SARS-CoV-2 & Influenza A/B Nucleic Acid Test

JIANGSU EUBO BIOLOGICAL TECHNOLO
Date Published : 06/22/2020
No. 18, Huashan Road, X , Jiangsu, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

JIANGSU MACRO & MICRO- TEST MED-TECH CO LTD
Date Published : 01/06/2022
Life And Health , No. 888 Zhu Jiang Road; Juegangzhen Rudongxian , Nantong, Jiangsu CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/06/2022

Desc: SARS-CoV-2 IgG/IgM Rapid Assay Kit (Colloidal Gold)

JOYSBIO (TIANJIN) BIOTECHNOLOGY CO., LTD.
Date Published : 07/07/2020
9th Floor , International Joint Academy Of Biotechnology & Medicine , Tianjin, Tianjin CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/07/2020

Desc: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/30/2021

Desc: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/07/2020

Desc: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/30/2021

Desc: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/30/2021

Desc: EasyRapidNow COVID-19 Nasal Swab Antigen Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/30/2021

Desc: EasyRapidNow COVID-19 Antigen Test/Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/30/2021

Desc: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/30/2021

Desc: EasyRapidNow COVID-19 Nasal Swab Antigen Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/30/2021

Desc: EasyRapidNow COVID-19 Antigen Test/Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/07/2020

Desc: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/30/2021

Desc: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

Jian Peng Zhou
Date Published : 06/11/2015
601 , 16-2 Luxing; Shizhong , Jining, Shandong CHINA
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 06/11/2015

Desc: Hyaluronic Acid Gel
Notes: Class III. Hyaluronic Acid Gel is a dermal filler marketed for the treatment of wrinkles and for buttocks and breast augmentation. Product is marketed on www.BeautyCosmeticStore.com.

Jiangdu Pengli Sport Goods Factory
Date Published : 03/07/2016
Wubao Town, Jiangdu Area , Yangzhou, Jiangsu CHINA
76 L - - RK Device, Anti-Snoring
Date Published: 01/23/2019

Desc: Snore Strip
Notes: 3/9/2016

Jiangsu Medomics Medical Technology Co., Ltd.
Date Published : 08/31/2021
Building C F 3 , 3 Xinjinhu Road; Gaoxin Jizhu Kaifa Pukou , Nanjing, Jiangsu CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: COVID-19 IgM-IgG Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: BioMedomics COVID-19 IgG Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: BioMedomics Gen3 COVID-19 IgM-IgG Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 08/31/2021

Desc: BioMedomics CoV-SCAN Rapid Antigen Test

Jiangsu Medomics Medical Technology Co., Ltd.
Date Published : 08/31/2021
Building C F 3 , 3 Xinjinhu Road; Gaoxin Jizhu Kaifa Pukou , Nanjing, Jiangsu CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: COVID-19 IgM-IgG Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: BioMedomics COVID-19 IgG Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: BioMedomics Gen3 COVID-19 IgM-IgG Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 08/31/2021

Desc: BioMedomics CoV-SCAN Rapid Antigen Test

Jiangsu Superbio Biomedical (Nanjing) Co., Ltd.
Date Published : 09/02/2020
Rooms 507-511, Block A, Sino-Danish Ecological Life Science Industrial Park, No.3-1 , Xinjinhu Road, Jiangbei New Area , Nanjing, Jiangsu CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/02/2020

Desc: SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/02/2020

Desc: SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/02/2020

Desc: SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)

Jiangyin Binjiang Medical Equipment Co., Ltd.
Date Published : 09/19/2011
Eastern Area of Chengjiang Town , Industrial Park , Jiangyin City, CHINA
80 F - - LE Sterilizer, Steam
Date Published: 09/19/2011

Desc: Portable Electric Steam Sterilizer (Model SYL-280B)
Notes: Class II

Jinagsu Healthcare Products Company, Limited
Date Published : 02/23/2024
Bldg. 1 Jian Xiang Yuan Room 1601 , No. 209 Bei Si Huan Zhong Road,Hai Di , Beijing, Beijing CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Powdered Free Vinyl Patient Examination Gloves Light Yellow Color
Notes: <<>>

Jufit Co Ltd.
Date Published : 02/19/2016
240 Blk 222 Yehui Road Qingpu , Shanghaishi, Shanghaishi CHINA
89 B - - XB Exerciser, Powered
Date Published: 02/19/2016

Desc: Vibration Plate
Notes: Ultra-Thin Body Slimmer

KANGMEI TIANHONG BIOTECH (BEIJING) CO., LTD
Date Published : 03/11/2021
# 16 , No. 1 Gaolizhang Road , Haidian, CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: Novir Insta COVID-19 Antibody Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: Novir COVID-19 SARS-CoV2 IgM/IgG Antibody rapid test

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: Novir COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)

KANGMEI TIANHONG BIOTECH BEIJING
Date Published : 03/11/2021
Hongxing Lou 16 , No 1 Courty , Beijing, Beijing CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: Novir Insta COVID-19 Antibody Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: Novir COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: Novir COVID-19 SARS-CoV2 IgM/IgG Antibody rapid test

King Mind Group
Date Published : 01/30/2012
5f No.2 Bldg Dalang Indl Zone , Shenzhen, CHINA
89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 01/30/2012

Desc: E Light Intense Pulsed Light Beauty Equipment
Notes: Class II

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 03/27/2012

Desc: Crystal Fat Deflagration Equipment
Notes: Class II

89 N - - XU Stimulator, ultrasound and muscle, for use in appling therapeutic deep heat, over the counter
Date Published: 03/27/2012

Desc: Crystal Fat Deflagration Equipment
Notes: Class II

89 N - - XU Stimulator, ultrasound and muscle, for use in appling therapeutic deep heat, over the counter
Date Published: 01/30/2012

Desc: E Light Intense Pulsed Light Beauty Equipment
Notes: Class II

Kingdom Plastic & Steel Co., Ltd.
Date Published : 07/07/2015
Chengyang Jiedao Dongwang Tuan , Gongyeyuan , Qingdao, Shandong CHINA
89 B - - XB Exerciser, Powered
Date Published: 07/07/2015

Desc: Exerciser; Powered
Notes: Power Vibe Whole Body Vibration Machine (WBV), Home Pro 2, Class II

LIMING BIO-PRODUCTS CO., LTD.
Date Published : 05/28/2021
No. 12 Huayuan Road , Nanjing, Jiangsu CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/29/2022

Desc: SARS-CoV-2 Real-TM

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/29/2022

Desc: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/29/2022

Desc: AccuraDTect SARS-CoV-2 RT-qPCR Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/19/2022

Desc: StrongStep SARS-CoV-2 lgM/IgG Antibody Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/28/2021

Desc: StrongStep System Device for SARS-CoV2 Antigen Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/28/2021

Desc: SARS-CoV2 Antigen Rapid Test

Lead Industrial Technology Co Ltd
Date Published : 12/11/2013
17 Distric Jiahe St , Guangzhou, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 12/11/2013

Desc: FACIAL MASSAGER FOR PERSONAL USE
Notes: class II

Lepu Medical Technology (Beijing) Co., Ltd.
Date Published : 05/28/2021
No. 37 Chaoqian Rd. , Changping , Changping, Beijing CHINA
83 O - - TG Non-sars coronavirus multiplex nucleic acid assay
Date Published: 05/28/2021

Desc: Covid Test

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 05/28/2021

Desc: SARS COV 2 Antigen Rapid Test

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 05/28/2021

Desc: Corona Virus Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/28/2021

Desc: Corona Virus Reagent Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/28/2021

Desc: SARS COV2 Antibody Test Colloidal Gold Immunochromatography

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/28/2021

Desc: SARS-COV-2 ANTIBODY TEST

88 P - - PM General purpose reagent
Date Published: 05/28/2021

Desc: Lepu Antigen Test

Les Products Co Ltd
Date Published : 08/21/2012
Rm No.804 Guanlida Buildingqianjin Rd , Shenzhenshenzhen, CHINA
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 08/21/2012

Desc: Bt-Micro Dermabrasion Unit
Notes: Class II

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 08/21/2012

Desc: Bt-Micro Dermabrasion Unit
Notes: class II

Letcom Medical Products Co.,Ltd.
Date Published : 09/19/2023
No. 66 Zhen Dong Road , Dongli , Tianjin, Tianjin CHINA
80 F - - MC Glove, Patient Examination
Date Published: 09/19/2023

Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove

80 L - - YY Glove, Patient Examination, Latex
Date Published: 09/19/2023

Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove

80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 09/19/2023

Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 09/19/2023

Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove

80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 09/19/2023

Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove

Lingen Precision Medical Products (Shanghai) Co., Ltd
Date Published : 08/19/2021
No. 59 Yewang Road, Ye , Shanghai, Shanghai CHINA
80 N - - NI Container, Specimen, Non-Sterile
Date Published: 08/19/2021

Desc: Viral Transport Media With Guanidine Hydrochloride And Isothiocyanate; models MTM-01; MTM-02; MTM-03; MTM-04; MTM-05

83 Q - - BD Microbial nucleic acid storage and stabilization device
Date Published: 08/19/2021

Desc: Viral Transport Media With Guanidine Hydrochloride And Isothiocyanate; models MTM-01; MTM-02; MTM-03; MTM-04; MTM-05

Lucky Beauty Equipment Co., LTD.
Date Published : 01/17/2014
Huaqiao Build Room , 1 Daqiao North Rd; Pukou , Nanjing, Jiangsu CHINA
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 01/17/2014

Desc: LBS11 RF Skin Lift
Notes: Class II

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 01/17/2014

Desc: Lbs56 Lipolaser
Notes: Class II

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 01/17/2014

Desc: Panda B; RF Beauty
Notes: Class II

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 01/17/2014

Desc: Lipolaser Machine
Notes: Class II

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 01/17/2014

Desc: Lbs54 lipo Laser Fat Burning
Notes: Class II

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 01/17/2014

Desc: Lbs12 Vertical RF
Notes: class II

79 G - - EX Powered laser surgical instruments
Date Published: 01/17/2014

Desc: Panda B; RF Beauty
Notes: Class II

79 G - - EX Powered laser surgical instruments
Date Published: 01/17/2014

Desc: Lipolaser Machine
Notes: Class II

79 G - - EX Powered laser surgical instruments
Date Published: 01/17/2014

Desc: LBS11 RF Skin Lift
Notes: Class II

79 G - - EX Powered laser surgical instruments
Date Published: 01/17/2014

Desc: Lbs12 Vertical RF
Notes: class II

79 G - - EX Powered laser surgical instruments
Date Published: 01/17/2014

Desc: Lbs56 Lipolaser
Notes: Class II

79 G - - EX Powered laser surgical instruments
Date Published: 01/17/2014

Desc: Lbs54 lipo Laser Fat Burning
Notes: Class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 01/17/2014

Desc: Lipolaser Machine
Notes: Class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 01/17/2014

Desc: Lbs54 lipo Laser Fat Burning
Notes: Class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 01/17/2014

Desc: Lbs12 Vertical RF
Notes: class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 01/17/2014

Desc: Lbs56 Lipolaser
Notes: Class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 01/17/2014

Desc: LBS11 RF Skin Lift
Notes: Class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 01/17/2014

Desc: Panda B; RF Beauty
Notes: Class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/17/2014

Desc: LBS11 RF Skin Lift
Notes: Class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/17/2014

Desc: Lbs54 lipo Laser Fat Burning
Notes: Class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/17/2014

Desc: Lipolaser Machine
Notes: Class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/17/2014

Desc: Lbs12 Vertical RF
Notes: class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/17/2014

Desc: Panda B; RF Beauty
Notes: Class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/17/2014

Desc: Lbs56 Lipolaser
Notes: Class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 01/17/2014

Desc: Lbs54 lipo Laser Fat Burning
Notes: Class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 01/17/2014

Desc: LBS11 RF Skin Lift
Notes: Class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 01/17/2014

Desc: Lipolaser Machine
Notes: Class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 01/17/2014

Desc: Panda B; RF Beauty
Notes: Class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 01/17/2014

Desc: Lbs56 Lipolaser
Notes: Class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 01/17/2014

Desc: Lbs12 Vertical RF
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/17/2014

Desc: Lbs12 Vertical RF
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/17/2014

Desc: LBS11 RF Skin Lift
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/17/2014

Desc: Panda B; RF Beauty
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/17/2014

Desc: Lbs54 lipo Laser Fat Burning
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/17/2014

Desc: Lbs56 Lipolaser
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/17/2014

Desc: Lipolaser Machine
Notes: Class II

Lucky Board Manufacturing
Date Published : 08/30/2013
No 34 Pingdi Section, Shen Huei Road , Pingdi Town, Longgong District , Shenzhen, Yandongsheng CHINA
80 F - - XX Mask, Surgical
Date Published: 11/08/2018

Desc: Surgical Mask
Notes: Class II

MACCURA BIOTECHNOLOGY CO LTD
Date Published : 01/29/2021
No. 8 Anhe No.2 Rd. , Hi-Tech Zone , Chengdu, Sichuan CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/29/2021

Desc: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method

MERLIN BIOMEDICAL (XIAMEN)
Date Published : 06/22/2021
4th Floor , Building B3, 2054 West Wengjiao Rd , Haicang , Xiamen, Fujian CHINA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: SARS-CoV-2 Antigen Rapid Test Cassette

MedicalSystem Biotechnology Co., Ltd.
Date Published : 10/19/2020
No. 299 Qiming South Road , Yinzhou District , Ningbo, Zhejiang CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/19/2020

Desc: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/19/2020

Desc: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/19/2020

Desc: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/19/2020

Desc: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit

Mei Ning Kang Cheng China Biotechnology R&D Center, Inc.
Date Published : 10/28/2020
D-201 Rencai Building, 10 Xinghuo Road , Nanjing, Jiangsu CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/28/2020

Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY
Notes: Class III device, requires 510(k), or de novo application

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/28/2020

Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY
Notes: Class III device, requires 510(k), or de novo application

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/28/2020

Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY
Notes: Class III device, requires 510(k), or de novo application

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/28/2020

Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY
Notes: Class III device, requires 510(k), or de novo application

Meikang Biological Project Co., Ltd.,
Date Published : 01/07/2011
4633 Pusan Road , Shanghai, CHINA
75 J - - HI Radioimmunoassay, Human Chorionic Gonadotropin
Date Published: 01/07/2011

Desc: All IVD Tests
Notes: 11/14/2008;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter
Date Published: 01/07/2011

Desc: All IVD Tests
Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

83 G - - TY Antigens, All Groups, Streptococcus Spp.
Date Published: 01/07/2011

Desc: All IVD Tests
Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

Meizi Beauty Equipment Co Ltd
Date Published : 10/24/2011
No 8 Building, North Rd Of School , Guangdong, CHINA
89 I - - LX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 10/24/2011

Desc: Personal Slimming Machine
Notes: Class III

Miracle International Co. Ltd
Date Published : 09/10/2010
Qilin Middle Rd , Guangzhou, Guangdong CHINA
80 L - - DQ Device, General Medical
Date Published: 09/10/2010

Desc: Executive Ion Detox Machine (TENS Unit; Far Infrared Belt; and Ion Detox)
Notes: Class II

Mokobio Life Science Corporation
Date Published : 10/28/2020
Floor 7-9, Building 5, Area 15, ABP , No 188 Western Road, South 4th Ring Road, Fengtai District , Beijing, Beijing CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/28/2020

Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY
Notes: Class III device, requires 510(k), or de novo application

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/28/2020

Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY
Notes: Class III device, requires 510(k), or de novo application

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/28/2020

Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY
Notes: Class III device, requires 510(k), or de novo application

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/28/2020

Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY
Notes: Class III device, requires 510(k), or de novo application

Mychway Co. Ltd.
Date Published : 05/05/2013
Pengdu Building Room 1701 , 126 Nanguang Road; Guangdong , Shenzhen, CHINA
79 G - - FE Brush, Dermabrasion
Date Published: 05/05/2013

Desc: Laser Lipolysis Device
Notes: class II

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Laser Lipolysis Device
Notes: class II

79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager
Date Published: 05/05/2013

Desc: Laser Lipolysis Device
Notes: class II

79 O - - RK Laser assisted lipolysis
Date Published: 05/05/2013

Desc: Laser Lipolysis Device
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 05/05/2013

Desc: Laser Lipolysis Device
Notes: class II

NANHAI MEISHIDA BEAUTY EQUIPMENT CO., LTD
Date Published : 09/20/2010
YANBU TOWN NANHAI , NO. 5 LIAN GUI ROAD INDUSTRIAL DISTRICT , Foshan, CHINA
73 C - - AW Generator, Oxygen, Portable
Date Published: 09/20/2010

Desc: Hair Steamer
Notes: Class II

79 G - - ED Brush, Dermabrasion, Manual
Date Published: 03/21/2013

Desc: Beauty Instruments
Notes: Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

79 G - - FE Brush, Dermabrasion
Date Published: 03/21/2013

Desc: Beauty Instruments
Notes: Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 03/21/2013

Desc: Beauty Instruments
Notes: Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

80 K - - MH Sterilizer, Dry Heat
Date Published: 03/21/2013

Desc: Beauty Instruments
Notes: Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 03/21/2013

Desc: Beauty Instruments
Notes: Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 03/21/2013

Desc: Beauty Instruments
Notes: Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/20/2010

Desc: Vaporizer
Notes: Class II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/20/2010

Desc: Facial Brush and Vacuum
Notes: Class II

89 I - - RO Vibrator, Therapeutic
Date Published: 03/21/2013

Desc: Beauty Instruments
Notes: Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/20/2010

Desc: Massage Hammer
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/20/2010

Desc: Cosmetic Vibrator
Notes: Class II

89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 03/21/2013

Desc: Beauty Instruments
Notes: Note; Product may be declared under Model M 2040 and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II

NANJING LONG MEDICAL TECHNOLOGY
Date Published : 12/18/2020
Times Plaza 488 , Nanjing, CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

NANJING VAZYME MEDICAL TECHNOLOGY Co Ltd
Date Published : 07/07/2020
Building C1-2, Red Maple Park of Technological Industry , Nanjing, Jiangsu CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/07/2020

Desc: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/07/2020

Desc: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/07/2020

Desc: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based)

NANTONG YIKUN MEDICAL APPARATUS
Date Published : 12/18/2020
198 Zhaoxia Road Nanton , Nantong, CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

Nanda Shine Rise Science Co Limited
Date Published : 06/30/2015
# 228 Guangzhou Road , Nanjing City, CHINA
89 L - - YG Massager, Therapeutic, Manual
Date Published: 06/30/2015

Desc: Massager
Notes: Rhino Roller; Class II

Nanjing Norman Biological Technology Co., Ltd
Date Published : 12/23/2020
No. 197 Pharmaceutical Valley Road , Jiangbei New Area , Nanjing, Jiangsu CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 12/23/2020

Desc: Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 01/11/2021

Desc: Novel Coronavirus (2019-nCOV) Antigen Testing Kit (Colloidal Gold)

Nanjing Shiny Value Industrial & Trading Co., LTD
Date Published : 06/30/2015
Yifa Tech Bldg 13C , 228 Guangzhoulu , Nanjing, Jiangsu CHINA
89 L - - YG Massager, Therapeutic, Manual
Date Published: 06/30/2015

Desc: Massager
Notes: Rhino Roller; Class II

Nantong Egens Biotechnology Co., Ltd.
Date Published : 06/22/2020
Building 15 , 1692 Xinghu Avenue , Nantong, Jiangsu CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: EGENS COVID-19 IgG/IgM Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: EGENS COVID-19 IgG/IgM Rapid Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: EGENS COVID-19 IgG/IgM Rapid Test Kit

Naxing Suzhou Bionanotech
Date Published : 09/04/2013
2f A2-210 218 Xinghu St , Suzhou, CHINA
80 N - - SC Injector, Pen
Date Published: 09/04/2013

Desc: Skin permeation enhancer beauty pens
Notes: Class II

New Vision Meditec Co., Ltd.
Date Published : 12/18/2020
B422 Gopha Mansion, 328 Xinghu St. , Jiangsu, CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

Newscen Coast Bio-Pharmaceutical Co
Date Published : 08/19/2021
No 65 6th Street, Teda , Tianjin, Tianjin CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/19/2021

Desc: Mi.Sens SAA/CRP/IgM/IgG Cov-19 Microfluidic Rapid Test System

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/19/2021

Desc: COVID-19 Microfluidic Combo Test

NingBo Huiyoo Baby Products Co., Ltd.
Date Published : 03/13/2023
# 523 , Cizhang Road; Zhangqi Industrial Area Cixi City , Cixi Ningbo, Zhejiang CHINA
85 H - - GX Pump, Breast, Powered
Date Published: 03/13/2023

Desc: BellaBaby Hands Free Electric Breast Pump (BLA8040/BLA8040-2)

Ningbo Finer Medical Instruments Co., Limited
Date Published : 12/18/2020
19/F Ningbo Commerce Chamber Mansion , Ningbo, CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

Ningbo Ruipu Medical Comfort Equipm
Date Published : 11/10/2011
NO. 8 , Gulin Industrial District , Yinzhouyinzhou, CHINA
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 11/10/2011

Desc: Radio Frequency Skin Lifting device
Notes: Class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 11/10/2011

Desc: Radio Frequency Skin Lifting device
Notes: Class II

ONETECH MEDICAL EQUIPMENT CO LIM
Date Published : 08/07/2017
19 YINGBIN , Guangzhou, Guangdong CHINA
90 E - - HD Unit, X-Ray, Extraoral With Timer
Date Published: 11/08/2018

Desc: Dental X Ray Machine
Notes: Class II

90 M - - UH System, X-Ray, Extraoral Source, Digital
Date Published: 08/07/2017

Desc: Dental X Ray Machine
Notes: Class II

ORANTECH INC
Date Published : 12/13/2021
Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District, , Shenzhen, Guangdon CHINA
73 D - - QA Oximeter
Date Published: 12/13/2021

Desc: Oximeter
Notes:                                                                                                                                                                                                                                                                            

Olivashow Co Limited
Date Published : 07/13/2012
Room 703 Bldg 7 Of Tong Tai Garden , Wenzhou Zhejiang, CHINA
79 M - - WZ Expander, Breast, External
Date Published: 07/13/2012

Desc: Plastic Cupping Set Breast Enlargement Cup
Notes: Class II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 07/13/2012

Desc: Plastic Cupping Set Breast Enlargement Cup
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 07/13/2012

Desc: Plastic Cupping Set Breast Enlargement Cup
Notes: class II

Ovid Trading Co Ltd
Date Published : 06/22/2011
Blk B&C 10/F Lee Hang Ind Bldg 10 Cheung , Cheung Sha Won Hong Koncheung Sha Won Ho, CHINA
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 06/22/2011

Desc: Impulse Ion
Notes: Class II

89 I - - LJ Bath, Hydro-Massage
Date Published: 06/22/2011

Desc: Impulse Ion
Notes: Class II

97 R - - AL Massager, Ultrasonic Non-Medical Devices
Date Published: 06/22/2011

Desc: Impulse Ion
Notes: Class II

Oyaga Beauty Equipment Co Ltd
Date Published : 08/19/2012
No 142 Dongfeng West Rd , Guangzhou, Guangdong CHINA
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 08/19/2012

Desc: GS8.0 Cavitation Machine
Notes: Class II

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 08/19/2012

Desc: GRF-11 Monopolor Radio Frequency machine
Notes: Class II

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 08/19/2012

Desc: GS8.0 Cavitation Machine
Notes: Class II

89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 08/19/2012

Desc: GRF-11 Monopolor Radio Frequency machine
Notes: Class II

PANAN AN HONGTONG PLASTIC & CRAFT PRODUCTS CO
Date Published : 09/16/2009
Jinshan Industrial Park , Dongyany , Zhejiang, CHINA
89 L - - YG Massager, Therapeutic, Manual
Date Published: 09/16/2009

Notes: 7/9/2009 Body Massage Kits.

PINGYANG COUNTRY SHICHENG E-COMM
Date Published : 06/08/2022
Rui'An Lin Yang Health , Wenzhou, CHINA
77 J - - YH Excavator, Ear
Date Published: 06/08/2022

Desc: Ear Cleaning Tool
Notes: For over the counter (OTC) use

77 O - - GQ Ear irrigation kit
Date Published: 06/08/2022

Desc: Ear Cleaning Tool
Notes: For over the counter (OTC) use

Pergrande Biotech Development Co., Ltd.
Date Published : 10/21/2020
Bldg 4 , No. 1 Yumin Avenue; Shunyi District Houshayu Town , Beijing, Beijing CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/21/2020

Desc: SARS-CoV-2 Antibody Detection Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/21/2020

Desc: SARS-CoV-2 Antibody Detection Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/21/2020

Desc: SARS-CoV-2 Antibody Detection Kit

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/21/2020

Desc: SARS-CoV-2 Antibody Detection Kit

Pioway Medical Lab Equipment Co. Ltd.
Date Published : 03/10/2014
Xinwanli Bldg Room 615A , NO. 9 Baixialu , Nanjing, Jiangsu CHINA
90 I - - TX Transducer, Ultrasonic, Diagnostic
Date Published: 03/10/2014

Desc: Digital Ultrasound Scanner
Notes: Class II

90 I - - YO System, Imaging, Pulsed Echo, Ultrasonic
Date Published: 03/10/2014

Desc: Digital Ultrasound Scanner
Notes: Class II

QINGDAO C-PLUS LEATHER CO LTD
Date Published : 04/04/2017
1000 Meters South West , Qingdao, CHINA
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 04/04/2017

Desc: Rhythm Tough Ultra (Nerve/Muscle Stimulator)

89 I - - PF Stimulator, Muscle, Powered
Date Published: 04/04/2017

Desc: Rhythm Tough Ultra (Nerve/Muscle Stimulator)

QINGDAO HIGHTOP BIOTECH CO., LTD.
Date Published : 04/20/2022
No. 369 Hedong Road , Hi-Tech Industrial Development Zone , Qingdao, Shandong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2022

Desc: SARS-CoV-2 IgM/IgG Antibody Rapid Test

RING BIOTECHNOLOGY CO LTD
Date Published : 01/06/2022
Building 3 , No 11 Kechuang 14 Street , Beijing, Beijing CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/06/2022

Desc: COVID-19 IgM/IgG Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/06/2022

Desc: COVID-19 IgM & IgG Rapid Test Kit

RING BIOTECHNOLOGY CO LTD.
Date Published : 01/06/2022
Hongxing Lou 3 , No 11 Kech; Bda , Beijing, Beijing CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/06/2022

Desc: COVID-19 IgM & IgG Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/06/2022

Desc: COVID-19 IgM/IgG Rapid Test Kit

Race Beauty Equipment Co., Ltd.
Date Published : 09/14/2012
Jiulong Industrial Park , No 23 Fenghuang 4 Rd , Guangzhou, Guangdong CHINA
79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Biolift Beauty Machine
Notes: class II

84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 09/14/2012

Desc: Biolift Beauty Machine
Notes: Class II

84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes
Date Published: 09/14/2012

Desc: Biolift Beauty Machine
Notes: class II

RayBiotech Guangzhou China
Date Published : 07/17/2020
79 Ruihe Street , Guangzhou, Guangdong CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/02/2021

Desc: QXD-3 COVIDNOW

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)

Re Chan Industry Co Ltd
Date Published : 09/02/2011
3 Fuyongjiedaoban Fuqiao Gongye , Baoan , Shenzhen, Guangdong CHINA
89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/02/2011

Desc: Magic Masseuse (Electronic Stimulation Massage unit)
Notes: Class II

SAFECARE BIOTECH(HANGZHOU)CO.,LTD
Date Published : 07/17/2020
2628 Yuhangtang Rd , Cangqian Sub-district,Yuhang District , Hangzhou, Zhejiang CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/02/2020

Desc: COVID-19 IgG/IgM Rapid Test Device

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/02/2020

Desc: SAFECARE 2019nCoV IgG/IgM Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma)

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/02/2020

Desc: SAFECARE 2019nCoV IgG/IgM Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/02/2020

Desc: COVID-19 IgG/IgM Rapid Test Device

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/02/2020

Desc: COVID-19 IgG/IgM Rapid Test Device

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/02/2020

Desc: SAFECARE 2019nCoV IgG/IgM Rapid Test

SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD
Date Published : 01/09/2024
6728 YONGQING ST , LINQU, Shandong CHINA
80 L - - YY Glove, Patient Examination, Latex
Date Published: 01/09/2024

Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves

80 L - - YY Glove, Patient Examination, Latex
Date Published: 01/29/2024

Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves

80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 01/09/2024

Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves

80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 01/29/2024

Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Powder-Free Nitrile Patient Examination Gloves Blue Color
Notes:                                                                 

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 01/29/2024

Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 01/09/2024

Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves

80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 01/29/2024

Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves

80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 01/09/2024

Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves

SHANDONG HUAMEI TECHNOLOGY CO.,LTD.
Date Published : 08/24/2021
588 Changning Street , High-Tech District , Weifang, Shandong CHINA
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 08/24/2021

Desc: Cavitation and Radio Frequency Slimming Machine HM-800

89 I - - SA Massager, Therapeutic, Electric
Date Published: 08/24/2021

Desc: Cavitation and Radio Frequency Slimming Machine HM-800

SHANDONG MEDICINES & HEALTH PRODUCTS IMP & EXP CO.
Date Published : 09/16/2009
18 Baodinglu , Shinan , Qingdao, Shandong CHINA
89 - - - -- Physical Medicine
Date Published: 09/16/2009

Notes: Shipper for Guanzhou NuhNan Shandong Medicines and Health Products. Positive/Negative Integrated Computer Control Augmented Sequential External Counter-Pulsation Device.

SHANDONG WANGQUAN COMMERCIAL KITCHENWARE IMPORT AND EXPORT CO LTD
Date Published : 12/04/2020
Zhaoma Village,Xingfu Town, Boxing , Northeast Area , Binzhou, CHINA
80 F - - LG Cleaner, Ultrasonic, Medical Instrument
Date Published: 12/04/2020

Desc: Disinfectant Machine

SHANGDONG THINKLAB BIOTECHNOLOGY
Date Published : 05/14/2021
No 1 Workshop No 10 Ind , Jining, CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: 2019-nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay)

SHANGHAI BAOBANG MEDICAL EQUIPMENT CO.,LTD.
Date Published : 06/24/2022
Building 15, No 889 , Shihu Dangzhen Songjiang , Shanghai, Shanghai CHINA
68 Z H G 99 Animal Medical Devices, NEC, Animal (Non-Food Producing), non-Rx, Non-Sterile
Date Published: 06/24/2022

Desc: Hyperbaric Chamber

73 B - - TI Compressor, Air, Portable
Date Published: 06/24/2022

Desc: Hyperbaric Chamber

73 C - - BF Chamber, Hyperbaric
Date Published: 06/24/2022

Desc: Hyperbaric Chamber

SHANGHAI BOLAN OPTICAL ELETRIC
Date Published : 12/18/2020
No. 29 Jiu Yuan Rd Qing , Shanghai, CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

SHANGHAI CHEMTRON BIOTECH CO., LTD
Date Published : 08/31/2021
No 518 Qingda Road , Shanghai, Shanghai CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: Chemtrue COVID-19 IgM/IgG Antibody Rapid Test

SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE CO. LTD.
Date Published : 07/07/2020
No. 830 Chenyin Rd. , District , Baoshan, Shanghai CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/07/2020

Desc: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/07/2020

Desc: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/07/2020

Desc: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit

SHANGHAI LIANGRUN BIOMEDICINE TECHNOLOGY CO., LTD
Date Published : 04/15/2021
LEVEL 4, BUILDING 1 , NO. 271 GANG'AO ROAD, PILOT FREE TRADE ZONE , Shanghai, Shanghai CHINA
83 O - - TG Non-sars coronavirus multiplex nucleic acid assay
Date Published: 04/15/2021

Desc: Liangrun COVID-19 IgM/IgG Antibody Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/15/2021

Desc: Diagnostic Kit for Detection of COVID-19 Antibodies (IgG/IgM)

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/15/2021

Desc: Liangrun COVID-19 IgM/IgG Antibody Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/15/2021

Desc: Liangrun COVID-19 IgM/IgG Antibody Test

83 Q - - MN COVID-19 Multi-Analyte Antigen Device
Date Published: 04/15/2021

Desc: Liangrun COVID-19 IgM/IgG Antibody Test

SHANGHAI ONETOUCH BUSINESS
Date Published : 06/09/2017
Room 1219, 1th floor, Building 8 , Guangs , Shanghai, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 06/09/2017

Desc: H8 Shockwave Massage Machine
Notes: Class I device without a valid 510K

SHANGHAI ONETOUCH BUSINESS
Date Published : 06/09/2017
Room 1219, 1th floor, Building 8 , Guangs , Shanghai, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 06/09/2017

Desc: H8 Shockwave Massage Machine
Notes: Class I device without a valid 510K

SHANGHAI TOP VIEW INDUSTRIAL CO Ltd
Date Published : 09/02/2020
3388 Gonghexin Rd, Jingan , Shanghai, CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 09/02/2020

Desc: Rebound Tonometer

86 H - - KY Tonometer, Manual
Date Published: 09/02/2020

Desc: Rebound Tonometer

86 H - - KZ Sterilizer, Tonometer
Date Published: 09/02/2020

Desc: Rebound Tonometer

86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 09/02/2020

Desc: Rebound Tonometer

SHANGHAI VOWISH OPTICAL CO., LTD
Date Published : 12/18/2020
2-310, No 555, Tianzhu , Shanghai, CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

SHENZEN JUMEIFENG TECHNOLOGY CO., LTD.
Date Published : 11/16/2016
28 Xingnong Road , Longgangjiedao Longgang , Shenzhen, Guangdong CHINA
79 M - - DM Instrument, Manual, General Surgical
Date Published: 11/16/2016

Desc: Microneedle Face Roller System

79 M - - DM Instrument, Manual, General Surgical
Date Published: 11/16/2016

Desc: Electric Microneedle Derma Pen System

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/16/2016

Desc: Electric Microneedle Derma Pen System

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/16/2016

Desc: Microneedle Face Roller System

SHENZHEN BEPERFECT TECH. CO., LTD.
Date Published : 10/19/2023
Building 16 , Shajing Town; Th , Ma'An Shan Ind. Zone Bao'An , Shenzhen, Guangdong CHINA
89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 10/19/2023

Desc: Synergy Neck Massager Model BP-1808

89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/19/2023

Desc: Synergy Neck Massager Model BP-1808

SHENZHEN CANWIN HEALTH PRODUCTS CO., LTD
Date Published : 04/20/2016
Guihua Rd , No. 302 Guanlan; Guanlanzhen Longgangcommunity , Shenzhen, Guangdong CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 04/20/2016

Desc: PowerUp Penis Pump

SHENZHEN FREEFLYING IND. & EXP. LTD.
Date Published : 04/18/2014
810 Dingxin Bldg A , Nanshan District; Xili Town , Shenzhen, CHINA
84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief
Date Published: 04/18/2014

Desc: Massager
Notes: Class II

84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes
Date Published: 04/18/2014

Desc: Massager
Notes: Class II

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 05/03/2021

Desc: Massager
Notes: Class II; 4/18/2014

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/18/2014

Desc: Massager
Notes: Class II

SHENZHEN JIERHONG TECHNOLOGY CO.
Date Published : 11/01/2023
10a Bk 3b,Jindimingfeng , Longgang District , Shenzhen, CHINA
89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 11/01/2023

Desc: Quantum Cuppergini Massager with Red Light Technology

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/01/2023

Desc: Quantum Cuppergini Massager with Red Light Technology

SHENZHEN JUNOBEAUTY TECHNOLOGY C
Date Published : 01/25/2021
No 512 Shajiing St , Shenzhen, CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 01/25/2021

Desc: Hair Removal Handset

79 O - - HT Light based over-the-counter hair removal
Date Published: 01/25/2021

Desc: Hair Removal Handset

SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD
Date Published : 03/11/2021
Fl R , 4th 71-5 Xintian Ave , Shenzhen, CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: True-Dot Novel Coronavirus (2019-nCoV) IgM/IgG rapid antibody detection kit

SHENZHEN LANDWIND HEALTH SCIENCE& TECHNOLOGY CO.
Date Published : 06/22/2020
Block A4 Floor 8 , No. 1001 Xueyuan; Nanshan District , Shenzhen, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: COVID-19 IgG/IgM RAPID TEST

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/06/2021

Desc: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: COVID-19 IgG/IgM RAPID TEST

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: COVID-19 IgG/IgM RAPID TEST

SHENZHEN LVSHIYUAN BIOTECHNOLOGY
Date Published : 10/21/2020
Building No.2 D , Industrial Avenue, Buxin Village, Buxin Community, Dapeng Subdistrict Office, Dapeng New Dist , Shenzhen, Dongguan CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 03/23/2021

Desc: Green Spring USA COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/21/2020

Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/21/2020

Desc: Green Spring COVID-19 IgG/IgM Rapid Test

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/21/2020

Desc: COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/21/2020

Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/23/2021

Desc: Green Spring USA COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/21/2020

Desc: COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/21/2020

Desc: Green Spring COVID-19 IgG/IgM Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/21/2020

Desc: COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/02/2021

Desc: Green Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/21/2020

Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/21/2020

Desc: Green Spring COVID-19 IgG/IgM Rapid Test

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/21/2020

Desc: Green Spring COVID-19 IgG/IgM Rapid Test

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/21/2020

Desc: COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/21/2020

Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method

SHENZHEN MYCHWAY TECHNOLOGY CO L
Date Published : 05/18/2015
F 4 , 406 Zhongxin Industr , Shenzhen, CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 05/18/2015

Desc: Lipolysis Laser
Notes: Class II

79 O - - RK Laser assisted lipolysis
Date Published: 05/18/2015

Desc: Lipolysis Laser
Notes: Class II

SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
Date Published : 08/30/2021
Science & Industry Park, Nanshan , Wearnes Tech Bldg F/4 , Shenzhen, Guangdong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: Diazyme SARS-CoV-2 Neutralizing Antibody CLIA kit

SHENZHEN RUNFENG DIGITAL TECHNOLOGY Co Ltd
Date Published : 11/22/2021
Chuanghui Building Room 2401-2403 , Intersection Of Banxuegang Blvd And Yongxiang Rd , Shenzhen, Guangdong CHINA
89 I - - RP Massager, Powered Inflatable Tube
Date Published: 11/22/2021

Desc: Renpho Leg Compression Massager

89 I - - RP Massager, Powered Inflatable Tube
Date Published: 11/22/2021

Desc: Leg Massager

89 I - - RP Massager, Powered Inflatable Tube
Date Published: 11/22/2021

Desc: Renpho Leg Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/22/2021

Desc: Renpho Leg Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/22/2021

Desc: Leg Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/22/2021

Desc: Renpho Leg Compression Massager

SHENZHEN SADES DIGITAL TECHNOLOG
Date Published : 06/19/2017
Heyiwei Industrial Park , Shatian Town , Dongguan, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 06/19/2017

Desc: Body Massager
Notes: Class I device; requires 510(k)

89 K - - NM Device, Pressure Applying
Date Published: 06/19/2017

Desc: Cupping Therapy Set
Notes: Class I device; requires 510(k)

89 L - - YG Massager, Therapeutic, Manual
Date Published: 06/19/2017

Desc: Cupping Therapy Set
Notes: Class I device; requires 510(k)

SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD.
Date Published : 05/11/2022
Building 2 4th Floor , West Side Of Xixiang Veterans Industry City, Gongle Community, Xixiang Street; Xinanzhen Baoan , Shenzhen, Guangdong CHINA
73 D - - QA Oximeter
Date Published: 05/11/2022

Desc: Disposable SpO2 sensor (oximeter) Neonatal (<3kg)

SHENZHEN SIST TECHNOLOGY CO LTD
Date Published : 06/17/2020
7th Fl , Block 2, Shunch , Shenzhen, CHINA
79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 06/17/2020

Desc: Neck Lift Premium Device

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 06/17/2020

Desc: Neck LED Spectrum Device

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 06/17/2020

Desc: Facial Multi Therapy Device

SHENZHEN WATMIND MEDICAL CO LTD
Date Published : 04/20/2022
8th Floor , Building A, No. 16-1, Jinhui Road, Jinsha Community, Kengzi Subdistrict; Pingshan District , Shenzhen, Guangdong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2022

Desc: SARS-CoV-2 IgG & IgM Ab Test Kit (Colloidal Gold)

SINGUWAY BIOTECH INC
Date Published : 01/26/2021
Room 306, No. 15 Bldg , Guangdong, CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: COVID-19 IgG/IgM Detection Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: Singuway COVID-19 Test Kit

SINOCARE INC.
Date Published : 10/21/2020
No. 265, Guyuan Road, H , I-Tech Zone, Changsha , Hunan, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/21/2020

Desc: SARS-CoV-2 Antibody Test Strip

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/21/2020

Desc: SARS-CoV-2 Antibody Test Strip

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/21/2020

Desc: SARS-CoV-2 Antibody Test Strip

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/21/2020

Desc: SARS-CoV-2 Antibody Test Strip

SSG (CHINA)
Date Published : 08/14/2017
No. 26 Jianguomen Nei Da Jie , 5th Floor, Beijing News Plaza , Beijing, Tianjin CHINA
80 I - - KY Mattress, Flotation Therapy, Non-Powered
Date Published: 08/14/2017

Desc: Floatation Capsule
Notes: Device Classification unknown.

SUNNY MEDICAL EQUIPMENT LTD
Date Published : 12/18/2020
Jinying Building No 316 , Guangzhou, Guangdong CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

SURE BIO TECH
Date Published : 07/16/2020
No.369 Hedong Road, Hi-Tech Industrial Development , Qingdao City Shandong, Shandong CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/16/2020

Desc: API Covid-Rapid IgM/IgG Antibody Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/23/2021

Desc: Covid-Rapid SARS-CoV-2 IgM/IgG AB (WB/S/P)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/16/2020

Desc: API Covid-Rapid IgM/IgG Antibody Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/23/2021

Desc: API Pharma Covid-Rapid IgM/IgG Antibody Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/16/2020

Desc: API Covid-Rapid IgM/IgG Antibody Test Kit

SUZHOU KANGHESHUN MEDICAL TECHNOLOGY CO., LTD
Date Published : 06/22/2020
Building 29 Room 403 3 , Suzhou, Jiangsu CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: SARS-CoV-2 IgG/IgM Rapid Test Cassette

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: SARS-CoV-2 IgG/IgM Rapid Test Cassette

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: SARS-CoV-2 IgG/IgM Rapid Test Cassette

SUZHOU PRECIGENOME LTD, CO
Date Published : 06/08/2022
218 Xinghu St Industria , Suzhou, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: FastPlex Triplex SARS-CoV-2 Detection Kit (RT- PCR)

SZ MAGIC
Date Published : 11/15/2017
Baiyun Zone, Shijing Town , Hongxing Industrial No 7 Road , Guangzhou, Guangdong CHINA
79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 11/15/2017

Desc: Facial Massager Machine; Ulthera System
Notes: Class II device without a valid 510K ;

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 11/15/2017

Desc: Facial Massager Machine; Ulthera System
Notes: Class II device without a valid 510K ;

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/15/2017

Desc: Facial Massager Machine; Ulthera System
Notes: Class II device without a valid 510K

Salon Art Company Limited
Date Published : 04/08/2015
7 D 22 Royalpark Plaza Helong Road First , Guangzhou, CHINA
79 L - - FL Instrument, Ultrasonic Surgical
Date Published: 10/18/2017

Desc: HIFU Ultrasonic Skin Lift (Beauty Machine)
Notes: Class II device without a valid 510K

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 10/18/2017

Desc: HIFU Ultrasonic Skin Lift (Beauty Machine)
Notes: Class II device without a valid 510K

79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite
Date Published: 10/18/2017

Desc: HIFU Ultrasonic Skin Lift (Beauty Machine)
Notes: Class II device without a valid 510K

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/08/2015

Desc: Air Pressure Body Slimming Suit
Notes: Class II device

Sanbor Medical Xiamen, Inc.
Date Published : 03/01/2011
1776 Lv Ling Road , Xiamen, Fujian CHINA
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 03/01/2011

Desc: ReBuilder 300 System; ReBuilder 2407 Personal System
Notes: Class II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 03/01/2011

Desc: ReBuilder 300 System; ReBuilder 2407 Personal System
Notes: Class II

Sanbor Medical Xiamen, Inc.
Date Published : 03/01/2011
1776 Lv Ling Road , Xiamen, Fujian CHINA
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 03/01/2011

Desc: ReBuilder 300 System; ReBuilder 2407 Personal System
Notes: Class II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 03/01/2011

Desc: ReBuilder 300 System; ReBuilder 2407 Personal System
Notes: Class II

Shandong Chengwu Medical Products Factory
Date Published : 08/19/2021
Southern End Of Quancheng Road, Chengwu County , Heze, Shandong CHINA
80 K - - XG Applicator, Absorbent Tipped, Sterile
Date Published: 10/06/2021

Desc: Disposable Virus Specimen Collection Tube

83 J - - SG Culture Media, Non-Selective And Non-Differential
Date Published: 10/06/2021

Desc: Viral transport media Viral transport tube

83 J - - SM Culture Media, Non-Propagating Transport
Date Published: 08/19/2021

Desc: Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04

83 Q - - MC Transport medium, notified per the VTM guidance
Date Published: 08/19/2021

Desc: Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04

Shandong Feiyang Professional Gloves Co., Ltd.
Date Published : 02/23/2024
338 Huaqing Drive , Qixin Chemical Industry Zone , Qinzhou, Shandong CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Nitrile Examination Gloves Powder Free (White)
Notes:                                                                 

Shandong Yinghong Medical Products Co Ltd
Date Published : 02/23/2024
Hongrun Industry Park , 15 East Road , Qingzhou, Shandong CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Powder-Free Nitrile Patient Examination Gloves
Notes:                                                                 

Shandong Yuanhang Medical Products Co Ltd
Date Published : 02/23/2024
Naoshan Industrial Park , 42666 Yaowang West Road , Qingzhou, Shandong CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Black Nitrile Powder Free Exam Gloves
Notes:                                                                 

Shanghai Aitomu Machinery Co., Ltd.
Date Published : 12/18/2020
No. 500 South Xiagyang Road , Shanghai, CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

Shanghai Angel Electronic Equipment Co., Ltd.
Date Published : 12/14/2015
Bldg. 5 F 4 , NO. 1135 Baotoulu , Shanghai, Shanghai CHINA
84 M - - VV Device, Acupressure
Date Published: 12/14/2015

Desc: Foot Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 12/14/2015

Desc: Foot Massager

Shanghai Bright Kun Industrial Limited
Date Published : 02/14/2017
D218 No.168 Jiugan Road , Shanghai, Shanghai CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 02/14/2017

Desc: Derma Needle Roller
Notes: Class I device without a valid 510k

89 K - - NM Device, Pressure Applying
Date Published: 02/14/2017

Desc: Derma Needle Roller
Notes: Class I device without a valid 510k

Shanghai Dasheng Health Products manufacture Co. L
Date Published : 09/01/2021
No. 228 Shihui Road , Songjiang , Shanghai, Shanghai CHINA
80 F - - XX Mask, Surgical
Date Published: 09/01/2021

Desc: Respirators Surgical

80 M - - SH Respirator, surgical
Date Published: 09/01/2021

Desc: Respirators Surgical

Shanghai Eugene Biotech Co Ltd
Date Published : 06/22/2020
Runcai Intelligent Industrial Park , Fengxian , Shanghai, Shanghai CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: SARS-CoV2 (COVID-19) IgG/IgM Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: SARS-CoV2 (COVID-19) IgG/IgM Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: SARS-CoV2 (COVID-19) IgG/IgM Rapid Test

Shanghai Healeasy Medical Equipment Co Ltd
Date Published : 11/03/2017
Fl 4 , 2 Yl Lane; Putuo , Shanghai, Shanghai CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/03/2017

Desc: Smart-Wave; Acoustic Wave System
Notes: Class I device without a valid 510K

Shanghai INTCO Medical Supply Co., Ltd.
Date Published : 03/10/2017
1358 Hubin Lu , Fengxian , Shanghai, Shanghai CHINA
80 F - - XX Mask, Surgical
Date Published: 11/08/2018

Desc: Face Mask
Notes: Device Classification is unknown

Shanghai Kindmax Sports Products Co.,Ltd
Date Published : 10/20/2014
Floor 3, No. 516 Wenchuan Road , Baoshan District , Shanghai, Shanghai CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 10/20/2014

Desc: Kindmax Therapy Tape
Notes: class 2

79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/15/2017

Desc: Precut Kinesiology Tape (Calf & Achilles Support; Foot Support)

79 M - - HW Dressing, Compression
Date Published: 10/20/2014

Desc: Kindmax Therapy Tape
Notes: class 2

80 F - - MQ Restraint, Protective
Date Published: 10/20/2014

Desc: Kindmax Therapy Tape
Notes: class 2

80 F - - QM Bandage, Elastic
Date Published: 09/15/2017

Desc: Precut Kinesiology Tape (Calf & Achilles Support; Foot Support)

Shanghai Meikang Biological Project Co.
Date Published : 01/07/2011
No 25 1150 Shenkanglu , Kangqiao Town, Pudong , Shanghaishi, Shanghaishi CHINA
75 J - - HI Radioimmunoassay, Human Chorionic Gonadotropin
Date Published: 01/07/2011

Desc: All IVD Tests
Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter
Date Published: 01/07/2011

Desc: All IVD Tests
Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

83 G - - TY Antigens, All Groups, Streptococcus Spp.
Date Published: 01/07/2011

Desc: All IVD Tests
Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

Shanghai Realov Electronic Technology Co Ltd
Date Published : 09/28/2017
Floor 3 , 799/26 Middle Jia Song Road , Shanghai, Shanghai CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 09/28/2017

Desc: Renegade Bolero Pump

85 K - - XQ Vibrator For Therapeutic Use, Genital
Date Published: 09/28/2017

Desc: Renegade Bolero Pump

Shanghai Smedent Medical Instrument Co., Ltd.
Date Published : 08/10/2011
Bldg. 10 Th Suite 310 , 3599 Qixin Rd , Shanghai, Shanghai CHINA
76 E - - LC Scaler, Ultrasonic
Date Published: 08/10/2011

Desc: Ultrasonic Scaler (B5 Model)
Notes: Class II

Shanguai Intco Import & Export Co. Ltd.
Date Published : 03/10/2017
3rd Fl Building 9, No 188 Newjunhuan Rd. , Shanghai, CHINA
80 F - - XX Mask, Surgical
Date Published: 11/08/2018

Desc: Face Mask
Notes: Device Classification is unknown

Shenyang Eksv Medical Equipment
Date Published : 10/31/2011
30 North Xinghua , Shenyang, CHINA
75 C - - DM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Date Published: 10/31/2011

Desc: EKSV-10A Urinalysis Test Strips
Notes: class II

75 C - - EN Dye-Indicator, Ph (Urinary, Non-Quant.)
Date Published: 10/31/2011

Desc: EKSV-10A Urinalysis Test Strips
Notes: class II

75 J - - IL Enzymatic Method, Glucose (Urinary, Non-Quant.)
Date Published: 10/31/2011

Desc: EKSV-10A Urinalysis Test Strips
Notes: Class II

75 J - - IN Nitroprusside, Ketones (Urinary, Non-Quant.)
Date Published: 10/31/2011

Desc: EKSV-10A Urinalysis Test Strips
Notes: class II

75 J - - IR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Date Published: 10/31/2011

Desc: EKSV-10A Urinalysis Test Strips
Notes: class II

75 J - - JB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Date Published: 10/31/2011

Desc: EKSV-10A Urinalysis Test Strips
Notes: class II

75 J - - MT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Date Published: 10/31/2011

Desc: EKSV-10A Urinalysis Test Strips
Notes: Class II

81 J - - IO Blood, Occult, Colorimetric, in Urine
Date Published: 10/31/2011

Desc: EKSV-10A Urinalysis Test Strips
Notes: class II

81 L - - JX Test, Urine Leukocyte
Date Published: 10/31/2011

Desc: EKSV-10A Urinalysis Test Strips
Notes: Class II

83 J - - XA Kit, Screening, Urine
Date Published: 10/31/2011

Desc: EKSV-10A Urinalysis Test Strips
Notes: Class II

Shenyang Xinzhen Medical Electronic Instrument Company
Date Published : 09/16/2009
No. 52 , North Huanghe Street , Shenyang, CHINA
84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 08/25/2023

Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator
Notes: DWPE Date 7/20/2005

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 08/25/2023

Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator
Notes: DWPE Date 7/20/2005

89 I - - PF Stimulator, Muscle, Powered
Date Published: 08/25/2023

Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator
Notes: DWPE Date 7/20/2005

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 08/25/2023

Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator
Notes: DWPE Date 7/20/2005

Shenzen Carewell Electronics Co.
Date Published : 09/16/2009
5a Huating 3 Guangye Rd , Shenzhen, FN CHINA
85 H - - EM Imager, Ultrasonic Obstetric-Gynecologic
Date Published: 08/25/2023

Desc: Ultrasound Scanner
Notes: DWPE Date 11/8/2007

90 L - - XE Doppler, Fetal, Ultrasound
Date Published: 08/25/2023

Desc: Ultrasound Scanner
Notes: DWPE Date 11/8/2007

90 M - - AA Monitor, Fetal Doppler Ultrasound
Date Published: 08/25/2023

Desc: Ultrasound Scanner
Notes: DWPE Date 11/8/2007

Shenzhen Beierkang Technology Co. Ltd.
Date Published : 04/20/2016
322 Jingkaidasha Qinghuyuan Longhua Area , Shenzhen, Guangdong CHINA
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 04/20/2016

Desc: Multifunction Infrared Thermometer
Notes: Class II Device. The Agency is unable to determine if the product is a device subject to a previously cleared 510(K) due to the lack of information in the product materials.

Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Date Published : 09/16/2009
Pingshan , New District 16 Kengzizhen Longgang , Shenzhen, Guangdong CHINA
85 H - - EM Imager, Ultrasonic Obstetric-Gynecologic
Date Published: 08/25/2023

Desc: BU-908 Electronic Convex Ultrasound Scanner
Notes: DWPE Date 12/8/2004

90 L - - XE Doppler, Fetal, Ultrasound
Date Published: 08/25/2023

Desc: BU-908 Electronic Convex Ultrasound Scanner
Notes: DWPE Date 12/8/2004

90 M - - AA Monitor, Fetal Doppler Ultrasound
Date Published: 08/25/2023

Desc: BU-908 Electronic Convex Ultrasound Scanner
Notes: DWPE Date 12/8/2004

Shenzhen Breo Technology Co., Ltd
Date Published : 02/13/2013
19/F, Hisense Southen Building, No. 1777 Chuangye Road , Nanshan District , SHENZHEN, GUANGDONG CHINA
84 M - - VV Device, Acupressure
Date Published: 04/01/2016

Desc: IDream3 Eye and Head Massager

84 M - - VV Device, Acupressure
Date Published: 03/18/2016

Desc: ISee108 Eye Massager

89 I - - RO Vibrator, Therapeutic
Date Published: 04/01/2016

Desc: IDream3 Eye and Head Massager

89 I - - RO Vibrator, Therapeutic
Date Published: 12/16/2015

Desc: iSee4 massager

89 I - - RO Vibrator, Therapeutic
Date Published: 02/13/2013

Desc: uCrown Pro Head
Notes: class II

89 I - - RO Vibrator, Therapeutic
Date Published: 02/13/2013

Desc: iComfort Eye-Z Eye and Temple Massager
Notes: class II

89 I - - RT Pad, Heating, Powered
Date Published: 12/16/2015

Desc: iSee4 massager

89 I - - RT Pad, Heating, Powered
Date Published: 10/05/2023

Desc: iDream 3 Head Massagers
Notes: 12/23/2022

89 I - - RT Pad, Heating, Powered
Date Published: 10/05/2023

Desc: iDream 5S Head Massagers
Notes: 12/23/2022

89 I - - RT Pad, Heating, Powered
Date Published: 02/13/2013

Desc: iComfort Eye-Z Eye and Temple Massager
Notes: class II

89 I - - RT Pad, Heating, Powered
Date Published: 02/13/2013

Desc: uCrown Pro Head & Eye Massager
Notes: class II

89 I - - RT Pad, Heating, Powered
Date Published: 04/01/2016

Desc: IDream3 Eye and Head Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/05/2023

Desc: iDream 5S Head Massagers
Notes: 12/23/2022

89 I - - SA Massager, Therapeutic, Electric
Date Published: 12/16/2015

Desc: iSee4 massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/18/2016

Desc: ISee108 Eye Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/01/2016

Desc: IDream3 Eye and Head Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 02/13/2013

Desc: uCrown Pro Head
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 02/13/2013

Desc: iComfort Eye-Z Eye and Temple Massager
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/05/2023

Desc: iDream 3 Head Massagers
Notes: 12/23/2022

Shenzhen Cas-Envision Medical Technology Co., Ltd.
Date Published : 04/05/2022
Bldg# F/4 , 4 Qidixiexin Science Park, No.333 Longfei Ave, Longcheng St; Longgang District , Shenzhen, Guangdong CHINA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/05/2022

Desc: SARS-CoV-2 Antigen Rapid Detection Kit

88 P - - PM General purpose reagent
Date Published: 04/05/2022

Desc: SARS-CoV-2 Antigen Rapid Detection Kit

Shenzhen Cosmo Catena Co Ltd
Date Published : 05/16/2014
3201 Kerry Center Renmin South Road Luo , Shenzhen, CHINA
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 05/16/2014

Desc: Stimulator; Nerve; Transcutaneous; For Pain Relief
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 05/16/2014

Desc: Stimulator; Nerve; Transcutaneous; For Pain Relief
Notes: Class II

Shenzhen Dowse Electronics Co Ltd
Date Published : 04/07/2013
5f No5 Bldg Minxing Industrialpark , Shenzhenshenzhen, CHINA
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 04/07/2013

Desc: Digital Therapy Machine Tens Unit
Notes: class II

Shenzhen Frifit Dev Co Ltd
Date Published : 03/07/2016
302 No 125 Anle One St , Baoan, CHINA
80 - - - -- General Hospital/Personal Use
Date Published: 11/08/2018

Desc: Derma Rollers

Shenzhen Hong Ji Pu Technology Co., Ltd.
Date Published : 06/03/2016
Technology Park 3rd Floor , Gongming Town; Lisonglang 2nd Ind. Zone , Shenzhen, Guangdong CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 06/03/2016

Desc: Stay Hard Beaded Cockrings

Shenzhen Huirun Import & Export Co
Date Published : 05/14/2012
Nanshan Road 1017lianhua International , Shenzhen, CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 05/14/2012

Desc: Penis Enlarger and Penis Extender
Notes: Class II

79 B - - TA Pump, Portable, Aspiration (Manual Or Powered)
Date Published: 05/14/2012

Desc: Penis Enlarger and Penis Extender
Notes: class II

Shenzhen Imdk Medical Technology Co., Ltd.
Date Published : 06/08/2022
10f,Building 16,Yuanshan Industrial B Area , Gongming Street; Guangming District , Shenzhen, Guangdong CHINA
73 D - - QA Oximeter
Date Published: 06/08/2022

Desc: Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1

73 D - - QA Oximeter
Date Published: 06/08/2022

Desc: Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2

73 Q - - LS Pulse oximeter for low-acuity settings
Date Published: 06/08/2022

Desc: Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2

73 Q - - LS Pulse oximeter for low-acuity settings
Date Published: 06/08/2022

Desc: Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1

74 O - - CH Oximeter, infrared, sporting, aviation
Date Published: 06/08/2022

Desc: Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1

74 O - - CH Oximeter, infrared, sporting, aviation
Date Published: 06/08/2022

Desc: Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2

Shenzhen Industry
Date Published : 07/20/2012
Rm 839 Fude Bldg Huaide Fuyong Town , Shenzhen, CHINA
74 D - - RW Adaptor, Lead Switching, Electrocardiograph
Date Published: 07/20/2012

Desc: Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado)
Notes: class II

86 N - - FH Digitizer, Images, Ophthalmic
Date Published: 07/20/2012

Desc: Iriscope (Iriscopio)
Notes: Class II

Shenzhen Jamr Medical Technology Co., Ltd
Date Published : 07/02/2021
A Building 2nd Floor , No. 2 Guiyuan Road; Guanlan Town. , Shenzhen, Guangdong CHINA
74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive
Date Published: 07/02/2021

Desc: Digital Blood Pressure Monitor Models; B01; B02; B05 & B06T

Shenzhen Jun Xin Tech Co Ltd
Date Published : 10/02/2015
4th Fl Huayi Packaging Factory , Foshan City, Guangdongsheng CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 10/02/2015

Desc: Micro Needle Roller
Notes: Class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 10/02/2015

Desc: Micro Needle Roller
Notes: Class II

Shenzhen Microprofit Biotech Co., Ltd.
Date Published : 06/22/2021
Rm. 405, 406, Zone B /4f, Rm. 205, 206-1, 207, West Side Of Zone B/ 2f, Haowei Bldg , 8 Langshan 2nd Road , Shenzhen, Guangdong CHINA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: COVID-19 DART

Shenzhen Oubok Technology Co Ltd
Date Published : 06/25/2013
6 F,Block 9, Huafeng Technology Park , Shenzhenshenzhen, CHINA
89 I - - LJ Bath, Hydro-Massage
Date Published: 06/25/2013

Desc: Foot detox machine
Notes: class II

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 06/25/2013

Desc: Foot detox machine
Notes: class II

Shenzhen Pango Electronic Co., Ltd
Date Published : 02/08/2012
6/F Dajia Bldg Dongchang Rd Luchu Dist , Shenzhen, CHINA
79 M - - WZ Expander, Breast, External
Date Published: 02/08/2012

Desc: Breast Enhancer Massager
Notes: class II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 02/08/2012

Desc: Breast Enhancer Massager
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 02/08/2012

Desc: Breast Enhancer Massager
Notes: class II

Shenzhen Pango Electronic Co., Ltd
Date Published : 02/08/2012
Xikeng Village, Henggang , No. 25 Fenghuang Road; 1st Industry Zone , Shenzhen, Guangdong CHINA
79 M - - WZ Expander, Breast, External
Date Published: 02/08/2012

Desc: Breast Enhancer Massager
Notes: class II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 02/08/2012

Desc: Breast Enhancer Massager
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 02/08/2012

Desc: Breast Enhancer Massager
Notes: class II

Shenzhen Perfect Idea Technology Co., Ltd.
Date Published : 01/22/2020
Building 1 F 4 , Fuyong Street; Baoan District , Shenzhen, Guangdong CHINA
79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 01/22/2020

Desc: Synergy Face Massager

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 01/22/2020

Desc: Synergy Eye Massager

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/22/2020

Desc: Synergy Eye Massager

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/22/2020

Desc: Synergy Face Massager

89 I - - RO Vibrator, Therapeutic
Date Published: 01/22/2020

Desc: Synergy Eye Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/22/2020

Desc: Synergy Eye Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/22/2020

Desc: Synergy Face Massager

Shenzhen Reagent Technology Co Ltd
Date Published : 12/03/2021
Hangcheng Wisdom Science Park R7777 , Shenzhen, Guangdong CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 12/03/2021

Desc: COVID-19 Real-Time Fluorescence PCR Detection Kit (lyophilized)

Shenzhen Ruichaoteng Technology Co. Ltd
Date Published : 04/25/2016
5F, Bldg B, Xitian Village , Gongming Town, Guangming District , Shenzhen, Guangdong CHINA
84 H - - CB Device, Aversive Conditioning
Date Published: 04/25/2016

Desc: Snore Stopper

Shenzhen Sheng Yang Kang Technical Co., Ltd.
Date Published : 07/15/2011
Longfeng Road , Longgangjiedao Longgang , Shenzhen, Guangdong CHINA
89 I - - LJ Bath, Hydro-Massage
Date Published: 07/15/2011

Desc: Detox Ion Foot Cleanse
Notes: CLASS II

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 07/15/2011

Desc: Detox Ion Foot Cleanse
Notes: CLASS II

Shenzhen Shengbanghua Technology Development Co., Ltd.
Date Published : 12/26/2018
Area A, Bldg 10, 1st Fl., Dongwu Industrial Zone, Donghuan First Rd , Longghua Street , Shenzhen, Guangdong CHINA
79 M - - DM Instrument, Manual, General Surgical
Date Published: 12/26/2018

Desc: Blackhead Remover

79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager
Date Published: 12/26/2018

Desc: Blackhead Remover

84 M - - VV Device, Acupressure
Date Published: 12/26/2018

Desc: Blackhead Remover

Shenzhen Wochuan Electronics Co., Ltd.
Date Published : 07/29/2015
Fifth Floor, No. 74 Zaoxia Road , Qiao Tou Community Fu Yong Town , Guangdong, CHINA
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 07/29/2015

Desc: Transcutaneous Nerve Stimulator
Notes: Class II

84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 07/29/2015

Desc: Transcutaneous Nerve Stimulator
Notes: Class II

84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 07/29/2015

Desc: Transcutaneous Nerve Stimulator
Notes: Class II

84 N - - YN Stimulator, electrical, transcutaneous, for arthritis
Date Published: 07/29/2015

Desc: Transcutaneous Nerve Stimulator
Notes: Class II

84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief
Date Published: 07/29/2015

Desc: Transcutaneous Nerve Stimulator
Notes: Class II

84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes
Date Published: 07/29/2015

Desc: Transcutaneous Nerve Stimulator
Notes: Class II

84 O - - CF Stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief
Date Published: 07/29/2015

Desc: Transcutaneous Nerve Stimulator
Notes: Class II

Shenzhen Ximeiyi Beauty Technolo
Date Published : 10/06/2015
3 Bldg , Longgang , Shenzhen, Guangdong CHINA
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 10/06/2015

Desc: Eye Massager
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/06/2015

Desc: Eye Massager
Notes: Class II

Singuway Biotech Inc.
Date Published : 01/11/2021
Julongshan A Road , Pingshan District , Shenzhen, Guangdong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/11/2021

Desc: COVID-19 IgG/IgM Detection Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/11/2021

Desc: Singuway COVID-19 Test Kit

Stareast Beauty & Health Mfg
Date Published : 08/01/2011
No 9 Bixi Road Daliang , Guangdong, CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 08/08/2011

Desc: Intense Pulsed Light (IPL) System (Non-Laser)
Notes: Class II

79 O - - NF Powered light based non-laser surgical instrument with thermal effect
Date Published: 08/01/2011

Desc: Intense Pulsed Light (IPL) System (Non-Laser)
Notes: Class II

Suichang Mingkang Charcoal Enterprise Co. Ltd
Date Published : 04/24/2017
144 Longtan Road , Suichangxian , Lishui, Zhejiang CHINA
89 I - - QI Orthosis, Limb Brace
Date Published: 04/24/2017

Desc: Carpal Support Gloves

Sunlive Technology Co Ltd
Date Published : 10/24/2013
Building C Taihua Junyi Park Xinhu , Road Bao'an District , Shenzhyen, Guangdong CHINA
79 O - - AP laser, comb, hair
Date Published: 10/23/2014

Desc: Capillus 272 Laser Hair Cap
Notes: Class III

95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 10/23/2014

Desc: Capillus 272 Laser Hair Cap
Notes: Class III

Sunny Optoelectronic Tech Co.Ltd
Date Published : 02/12/2015
F 2 , No 1661 Jia Luo Highway; Jiading , Shanghai, Shanghai CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 02/12/2015

Desc: Diode Laser Beauty Machine

Suqian Bing De Biotechnology Co.
Date Published : 05/24/2016
Xu Ning Road, Si Hong County , Su Qian, Jiangsu CHINA
76 L - - QZ Device, Jaw Repositioning
Date Published: 05/24/2016

Desc: Anti Snore Chin Strap
Notes: Products do not have a valid 510(K) clearance.

76 L - - RK Device, Anti-Snoring
Date Published: 05/24/2016

Desc: Anti Snore Chin Strap
Notes: Products do not have a valid 510(K) clearance.

Suzhou Armocon Technology Co.Ltd
Date Published : 12/10/2012
D, Sip F 3 , No. 77 Suhong Middle Rd; Zhongxin Gongyeyuan , Suzhou, Jiangsu CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 05/22/2014

Desc: Penis Ring
Notes: Class II; 12/10/12

Suzhou Kangjie Medical Inc.
Date Published : 12/18/2020
Bldg 15, No 2, Shuangma St , Weiting Town , Suzhou, Jiangsu CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

Suzhou Medical Appliance Factory
Date Published : 03/21/2017
Sstt , No. 18 Huatuo Road; Suzhou New District , Suzhou, Jiangsu CHINA
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 03/21/2017

Desc: Nerve and Muscle Stimulator

89 I - - PF Stimulator, Muscle, Powered
Date Published: 03/21/2017

Desc: Nerve and Muscle Stimulator

89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/21/2017

Desc: Nerve and Muscle Stimulator

Suzhou Precigenome Ltd Co
Date Published : 06/08/2022
218 Xinghu Street, A4-101, Biobay , Suzhou, Jiangsu CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: FastPlex Triplex SARS-CoV-2 Detection Kit (RT- PCR)

Syntex Healthcare Products Co., Ltd.
Date Published : 02/23/2024
No. 1 Fangjiazhuang Industrial Zone , Xinji City , Hebei Province, CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Powder-Free Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs
Notes:                                                                 

80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 02/23/2024

Desc: Powder-Free Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs
Notes:                                                                 

TIANJIN FUSHEN SCIENCE AND TECHNOLOGY CO., LTD.
Date Published : 04/07/2017
Third Floor , D-18 Tower,Huigu Science And Technology Park,Xuefu Industrial Zone,Xiqing District; Xiqing , Tianjin, Tianjin CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 04/07/2017

Desc: Detox Foot Pads (Luminositie)

TIANJIN GRAND PAPER INDUSTRY CO., LTD
Date Published : 07/12/2021
Hongguang Farm , Beichen , Tianjin, Tianjin CHINA
82 J - - ZR Support Gels
Date Published: 07/12/2021

Desc: Ultrasound Gel

90 M - - UI Media, Coupling, Ultrasound
Date Published: 07/12/2021

Desc: Ultrasound Gel

Tang Shuwei Dongti
Date Published : 09/16/2009
# Lujing Xilu Yuexiuqu 54 , 102 Xiatang Xincun , Guangzhou, Guangdong CHINA
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: 2/16/2007 HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: 2/16/2007 HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Tianjin Fuqin Science And Technology Co Ltd
Date Published : 04/07/2017
Tower Ab Xinmao Science Room E7 F 5 , Nankai , Tianjin, Tianjin CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 04/07/2017

Desc: Detox Foot Pads (Luminositie)

Tianjin New Bay Bioresearch Co., Ltd.
Date Published : 04/29/2021
3 Jianshe Road , Ba Li Tai Industry Areadistrict , Jinnan, Tianjin CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/29/2021

Desc: QuikPac II Covid-19 IgG & IgM Test

Tuos International Trade
Date Published : 03/12/2014
Xiaojing Village , Guangzhou, CHINA
84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 03/12/2014

Desc: Transcutaneous Electrical Nerve Stimulator (Portable High Frequency)
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/12/2014

Desc: Transcutaneous Electrical Nerve Stimulator (Portable High Frequency)
Notes: Class II

Tzong Rong Optical Co., Ltd.
Date Published : 05/22/2012
107 Country Road, West , Industry Development Area Shihling Town , Hua-Du City, Guangdong CHINA
86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 05/22/2012

Desc: Pinhole Sunglasses
Notes: Class II

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 05/22/2012

Desc: Pinhole Glasses
Notes: Class II

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 05/22/2012

Desc: Pinhole Sunglasses
Notes: Class II

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 05/22/2012

Desc: Pinhole Glasses
Notes: Class II

Unimed Medical Supplies Inc
Date Published : 02/09/2022
Bldg. 8, Nangang 3rd Industrial Park , Tangtou, Shiyan, Baoan , Shenzhen, Guangdong CHINA
73 D - - PZ Oximeter, Ear
Date Published: 09/21/2022

Desc: Reusable Adult Ear Clip Sensors (U903-01) Oximeter

73 D - - QA Oximeter
Date Published: 02/09/2022

Desc: Disposable SpO2 Sensors (Oximeters); Nellcor Oximax Compatible

73 D - - QA Oximeter
Date Published: 09/21/2022

Desc: Reusable Adult Finger Clip Sensor (U403-49 or U403-49R) Oximeter

73 D - - QA Oximeter
Date Published: 07/25/2022

Desc: Reusable SpO2 Sensor/Masimo/finger clip/Adult/1 1M/125; U403-125R

73 D - - QA Oximeter
Date Published: 05/02/2022

Desc: Disposable MAS-LINCS Pdtx SpO2 Sensors

73 D - - QA Oximeter
Date Published: 09/21/2022

Desc: Reusable Adult Ear Clip Sensors (U903-01) Oximeter

73 D - - QA Oximeter
Date Published: 03/24/2022

Desc: Reusable SpO2 Sensor/CSI/finger clip/Adult/3 0M/DB9 U410-75

73 D - - QA Oximeter
Date Published: 03/11/2022

Desc: Reusable SpO2 Sensors (Oximeters)
Notes:                                                                                                                                                                                                                                                                                                                                                                                                                                                                  

73 P - - GJ Oximeter, wellness
Date Published: 09/21/2022

Desc: Reusable Adult Finger Clip Sensor (U403-49 or U403-49R) Oximeter

73 P - - GJ Oximeter, wellness
Date Published: 09/21/2022

Desc: Reusable Adult Ear Clip Sensors (U903-01) Oximeter

Ustar Biotechnologies (Hangzhou
Date Published : 01/06/2022
New Century Tower Fl 8 , 3766 Nanhuan Rd , Hangzhou, Zhejiang CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/06/2022

Desc: EasyNAT Diagnostic Kit for Novel- Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay

VIVACHEK BIOTECH (HANGZHOU) CO LTD
Date Published : 01/11/2021
Level 2 , Block 2 146 Eas , Hangzhou, Zhejiang CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: VivaDiag COVID-19 IgM/IgG Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/11/2021

Desc: VivaDiag COVID-10 IgM/IgG Rapid Test

VIVACHEK BIOTECH (HANGZHOU) CO, ltd.
Date Published : 01/26/2021
1/2/3 F, Building 1, 16 East Zhenxing Rd. , Yuhang Economy Development Zone , Hangzhou, Zhejiang CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: VivaDiag COVID-19 IgM/IgG Rapid Test

WEIFANG HUAMEI ELECTRONICS CO.,LTD.
Date Published : 06/28/2011
588 Chang Ning Street , High-Tech District , Weifang, Shandong CHINA
79 O - - HT Light based over-the-counter hair removal
Date Published: 06/28/2011

Desc: Intense Pulsed Light System Face Skin Cleaner
Notes: Class II

WEIFANG KM ELECTRONICS CO., LTD
Date Published : 11/02/2011
No. 7999 Health East Street , High-Tech District , Weifang, Shandong CHINA
79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 04/23/2014

Desc: Ultrasonic Cavitation Devices
Notes: class II

79 P - - BX Massager, vacuum, radio frequency induced heat
Date Published: 04/23/2014

Desc: Ultrasonic Cavitation Devices
Notes: class II

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 01/30/2019

Desc: Ultrasound Beauty Machine
Notes: Class II; 11/02/2011

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 01/30/2019

Desc: Massager
Notes: Class II; 3/8/2013

89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/08/2013

Desc: Massager
Notes: Class II

89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 04/23/2014

Desc: Ultrasonic Cavitation Devices
Notes: Class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 03/08/2013

Desc: Massager
Notes: class II

WUHAN EASYDIAGNOSIS BIOMEDICINE CO Ltd
Date Published : 07/17/2020
No.388, Gaoxin 2nd RD, East Lake HiTech Development Zone , Room 3 & 4, 2nd Floor, Bldg 25, Phase 3.1 Wuhan Optics Valley International Biopharmaceutical Enterprise Accel , Wuhan, Hubei CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test

WUHAN EASYDIAGNOSIS BIOMEDICINE CO Ltd
Date Published : 07/17/2020
No.388, Gaoxin 2nd RD, East Lake HiTech Development Zone , Room 3 & 4, 2nd Floor, Bldg 25, Phase 3.1 Wuhan Optics Valley International Biopharmaceutical Enterprise Accel , Wuhan, Hubei CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test

WUHAN GUANGDUN TECHNOLOGY CO LTD
Date Published : 08/04/2017
F 3 , 303 Optical Valley Avenue; 3f, No. 303 Optical Chip Center, Optical Avenue , Wuhan, Hubei CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 08/04/2017

Desc: Medical Laser
Notes: Class II

89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy
Date Published: 08/04/2017

Desc: Medical Laser
Notes: Class II

Wei Cia Ma Kang Co Ltd
Date Published : 01/17/2014
Wang Yu Jie , Wei Cia, CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 01/17/2014

Desc: Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles
Notes: Class II

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles
Notes: class II

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 01/17/2014

Desc: Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles
Notes: class II

Welmay Beauty Equipment Co Ltd
Date Published : 08/17/2016
NO 138 Helong Rd , Guangzhou, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 08/17/2016

Desc: Massage Machine

Wenzhou Bokang Instrument Co., Ltd.
Date Published : 04/17/2019
In Longwan , No. 1500 Haibin Street; Zhejiang Prov , Wenzhou, Zhejiang CHINA
79 K - - CY Tourniquet, Pneumatic
Date Published: 04/17/2019

Desc: Smart Cuff

Wenzhou Lichang Body-Training Equipment Co., Ltd.
Date Published : 09/17/2012
Xiasong Industry Zone, Songqiao Town, , Wenzhou, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/17/2012

Desc: Massagers Models; OS-102A; 103A; 105A; 106A; & 107A ONLY
Notes: Class II

Woduo Llc
Date Published : 10/14/2015
2nd Fl C , Bldg The Second; Baoan , Shenzhen, Guangdong CHINA
79 G - - FE Brush, Dermabrasion
Date Published: 10/14/2015

Desc: Dermaroller
Notes: class II

Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Date Published : 04/15/2021
Wuhan Hi-Tech Medical Devices Park, Building B11, #818 Gaoxin Road, Donghu Hi , Tech Development Area , Wuhan, Hubei CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/15/2021

Desc: SARS-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography)

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/15/2021

Desc: Szybio Life Origin Biotech SARS-SoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography)

Wuhan Lotuxs Technology Co., Ltd.
Date Published : 09/02/2020
5F, E2 BUILDING, NO.999 GAOXIN AVENUE, , FUTURE CITY, , EAST LAKE HIGH-TECH DEVELOPMENT ZONE , Wuhan, Hubei CHINA
79 O - - HT Light based over-the-counter hair removal
Date Published: 09/02/2020

Desc: Pink Luminous Breast
Notes: Class III device, requires 510(k), or de novo application

79 P - - KT Laser for disruption of adipocyte cells for aesthetic use
Date Published: 09/02/2020

Desc: Pink Luminous Breast
Notes: Class III device, requires 510(k), or de novo application

80 F - - LG Cleaner, Ultrasonic, Medical Instrument
Date Published: 09/02/2020

Desc: Pink Luminous Breast
Notes: Class III device, requires 510(k), or de novo application

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 09/02/2020

Desc: Pink Luminous Breast
Notes: Class III device, requires 510(k), or de novo application

90 L - - EK Transilluminator (Diaphanoscope)
Date Published: 09/02/2020

Desc: Pink Luminous Breast
Notes: Class III device, requires 510(k), or de novo application

Wuhan UNScience Biotechnology Co Ltd
Date Published : 01/26/2021
Building B18, 2nd Phase of Biomedical Park , #858 GaoXin Rd , Wuhan, Hubei CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold)

Wuhu 3H Biotechnology Co., Ltd.
Date Published : 10/20/2020
No. 369 Nanci First Road, Anhui Xinwu Economic Development Zone, Wuhu County , Wuhu, Anhui CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/20/2020

Desc: COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/20/2020

Desc: COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/20/2020

Desc: COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/20/2020

Desc: COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)

XIAMEN AMONMED BIO
Date Published : 07/17/2020
120 Xinyuan Road H , Xiamen Haican, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)

XIAMEN BAYSEN MEDI
Date Published : 07/27/2021
UNIT 401, NO 1 JINZHONG ROAD , HULI DISTRICT , Xiamen, CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/27/2021

Desc: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/27/2021

Desc: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: SARS-CoV-2 Antigen Rapid Test

83 Q - - LW COVID-19 test home collection kit devices
Date Published: 07/27/2021

Desc: COVID-19 Risk Test

XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED
Date Published : 11/22/2021
Building D Floor 2-3 , NO. 100 Jinfu Road; Tongan District , Xiamen, Fujian CHINA
89 I - - RP Massager, Powered Inflatable Tube
Date Published: 08/02/2023

Desc: Leg Massager with Heat
Notes: Only the following models are subject to the alert: EMK-702, EMK-707, EMK-703B, EMK-707B, SHI-66, SHI-77, RF-ALM072-H, EMK-712, RP-ALM075

89 I - - SA Massager, Therapeutic, Electric
Date Published: 08/02/2023

Desc: Leg Massager with Heat
Notes: Only the following models are subject to the alert: EMK-702, EMK-707, EMK-703B, EMK-707B, SHI-66, SHI-77, RF-ALM072-H, EMK-712, RP-ALM075

XIAMEN HIGH TOP ELECTRONIC TECHNOLOGY CO.,LTD.
Date Published : 05/24/2022
F 2-5 , Simingyuan No.118 , Xiamen, Fujian CHINA
89 I - - RP Massager, Powered Inflatable Tube
Date Published: 05/24/2022

Desc: LEG MASSAGER; model RF-ALM071

89 I - - SA Massager, Therapeutic, Electric
Date Published: 05/24/2022

Desc: LEG MASSAGER; model RF-ALM071

XIAN TRIUMPH TECH CO LTD
Date Published : 12/12/2022
Bldg 3 No 4955 5th Fl , Shangyuan Road; Caotan Ecological Industrial Park , Xi'An, Shaanxi CHINA
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

79 G - - EX Powered laser surgical instruments
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

79 N - - RJ Ultrasound, Skin Permeation
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

79 O - - YW For the removal of fat through laser lipolysis
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

79 P - - BX Massager, vacuum, radio frequency induced heat
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

79 P - - ZC Ablation system, high intensity focus ultrasound (HiFU), soft tissue
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

79 P - - ZL Extracorporeal shock wave device for treatment of diabetic foot ulcers
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

86 Q - - BR Intranasal electrostimulation device for dry eye symptoms
Date Published: 12/12/2022

Desc: Sxkeysun Cryolipolysis Slimming Machine

Xiamen Biotime Biotechnology Company
Date Published : 03/02/2021
2F/3F/4F, No. 188, , Pingcheng South Road, Haicang Street, Haicang District, , Xiamen, Fujian CHINA
83 L - - IB Device, General Purpose, Microbiology, Diagnostic
Date Published: 03/02/2021

Desc: SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST
Notes:                                                                                                          

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/20/2021

Desc: INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/20/2021

Desc: Innova COVID-19 Self-Test kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 03/02/2021

Desc: SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST
Notes:                                                                                                          

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/20/2021

Desc: BIOTIME SARS-CoV-2 Antigen Rapid Qualitative Test

Xiamen Electronic Instrument Plant
Date Published : 03/08/2011
Unknown , Fujian, CHINA
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Multifunctional Massager
Notes: Class III

Xiamen Vbet Electronics Co Ltd
Date Published : 05/05/2013
N403 Weiye , Xiamen, CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 05/05/2013

Desc: Electric massagers Mio and Ami and Je Joue Brandd Vibrators
Notes: Class II

85 K - - XQ Vibrator For Therapeutic Use, Genital
Date Published: 05/05/2013

Desc: Electric massagers Mio and Ami and Je Joue Brandd Vibrators
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 05/05/2013

Desc: Electric massagers Mio and Ami and Je Joue Brandd Vibrators
Notes: class II

Xiamen Wiz Biotech Co., Ltd.
Date Published : 10/22/2020
Bio-Medical Workshop, Floor 3-4, Bldg 16 , 2030 Wengjiao West Road; Haicang , Xiamen, Fujian CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/22/2020

Desc: DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/22/2020

Desc: DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/22/2020

Desc: DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/22/2020

Desc: DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2

YANCHENG LOUDLY OPTICAL CO LTD
Date Published : 12/18/2020
No 22 Xiwang Road , Yancheng, Jiangsu CHINA
86 H - - KX Tonometer, Ac-Powered
Date Published: 12/18/2020

Desc: Rebound Tonometer

YONGKANG JINKANG HEALTH EQUIPMENT FACTORY
Date Published : 06/19/2017
TONGXI INDUSTRY ZONE , TANGXIAN , Yongkang, ZHEJIANG CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 06/19/2017

Desc: Body Massager
Notes: Class I device; requires 510(k)

89 K - - NM Device, Pressure Applying
Date Published: 06/19/2017

Desc: Cupping Therapy Set
Notes: Class I device; requires 510(k);                                                                                                                                                                                                                                                                                                                                                                                                              

89 L - - YG Massager, Therapeutic, Manual
Date Published: 06/19/2017

Desc: Cupping Therapy Set
Notes: Class I device; requires 510(k);                                                                                                                                                                                                                                                                                                                                                                                                              

Yall Store
Date Published : 07/13/2012
N 3p Yue Ao Pu Hua Technology Parkda , Baoan , Shenzhen, Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

74 - - - -- Cardiovascular
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

76 - - - -- Dental
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

77 - - - -- Ear,Nose And Throat
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

78 - - - -- Gastroenterological & Urological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

79 - - - -- General & Plastic Surgery
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

80 - - - -- General Hospital/Personal Use
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

84 - - - -- Neurological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

85 - - - -- Obstetrical & Gynecological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

86 - - - -- Ophthalmic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

87 - - - -- Orthopedic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

89 - - - -- Physical Medicine
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

90 - - - -- Radiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

Yall Store
Date Published : 07/13/2012
2F Bldg C, Longjing 2nd , Shenzhenshenzhen, CHINA
73 - - - -- Anesthesiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

74 - - - -- Cardiovascular
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

76 - - - -- Dental
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

77 - - - -- Ear,Nose And Throat
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

78 - - - -- Gastroenterological & Urological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

79 - - - -- General & Plastic Surgery
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

80 - - - -- General Hospital/Personal Use
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

84 - - - -- Neurological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

85 - - - -- Obstetrical & Gynecological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

86 - - - -- Ophthalmic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

87 - - - -- Orthopedic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

89 - - - -- Physical Medicine
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

90 - - - -- Radiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

Yall Store
Date Published : 07/13/2012
Shenzhen Minzhi Jie Doa Minkang Rd , Shenzhenshenzhen, CHINA
73 - - - -- Anesthesiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

74 - - - -- Cardiovascular
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

76 - - - -- Dental
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

77 - - - -- Ear,Nose And Throat
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

78 - - - -- Gastroenterological & Urological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

79 - - - -- General & Plastic Surgery
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

80 - - - -- General Hospital/Personal Use
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

84 - - - -- Neurological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

85 - - - -- Obstetrical & Gynecological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

86 - - - -- Ophthalmic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

87 - - - -- Orthopedic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

89 - - - -- Physical Medicine
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

90 - - - -- Radiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

Yall Store
Date Published : 07/13/2012
43rd Building , Yiwu, CHINA
73 - - - -- Anesthesiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

74 - - - -- Cardiovascular
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

76 - - - -- Dental
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

77 - - - -- Ear,Nose And Throat
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

78 - - - -- Gastroenterological & Urological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

79 - - - -- General & Plastic Surgery
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

80 - - - -- General Hospital/Personal Use
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

84 - - - -- Neurological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

85 - - - -- Obstetrical & Gynecological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

86 - - - -- Ophthalmic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

87 - - - -- Orthopedic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

89 - - - -- Physical Medicine
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

90 - - - -- Radiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

Yangjiang Nextorch Co Ltd
Date Published : 12/08/2016
NO. 61 Yudong Yi Road , Dongcheng Town , Shenzhen, CHINA
79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 12/08/2016

Desc: Electrical Facial Mask
Notes:                                                                                    

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 12/08/2016

Desc: Electrical Facial Mask
Notes:                                                                                    

Yongkang Jiuling Industry & Trade Co Ltd
Date Published : 11/19/2014
No2 Bu Yang Rd , Yongkang, CHINA
79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Handheld Foot Massager
Notes: Class 2;For example; claims include Rehabilitation treatment for the diseases such as headaches; migraine headaches; neck and shoulder acid; stomach pain; fatigue; abnormal blood pressure; constipation; weight loss; detoxification; lack of sleep; insomnia; cold; pressure; dysmennorheal; menopause syndrome; irregular menstruation; infertility; etc.

84 M - - VV Device, Acupressure
Date Published: 11/19/2014

Desc: Handheld Foot Massager
Notes: Class 2;For example; claims include Rehabilitation treatment for the diseases such as headaches; migraine headaches; neck and shoulder acid; stomach pain; fatigue; abnormal blood pressure; constipation; weight loss; detoxification; lack of sleep; insomnia; cold; pressure; dysmennorheal; menopause syndrome; irregular menstruation; infertility; etc.

ZHEJIANG GENE SCIENCE CO., LTD
Date Published : 06/22/2021
No. 2 Workshop, Pharmaceutical Industrial Park, No. 11 Shengxing Road, Shangyu Economic And Technological Dev , Shaoxing, Zhejiang CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/19/2022

Desc: Novel Coronavirus (2019nCov) IgM/IgG Antibodies Detection Kit (Latex Chromatography)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography)

ZHEJIANG XICHEN MEDICAL TECHNOLOGY CO LTD
Date Published : 03/16/2022
F/2 , 3 Bldg, 6 Lvyuan Rd , Quzhou, Zhejiang CHINA
80 F - - XX Mask, Surgical
Date Published: 03/16/2022

Desc: Sterile Surgical Mask

80 F - - XX Mask, Surgical
Date Published: 03/16/2022

Desc: KN95 Face Mask

80 F - - XX Mask, Surgical
Date Published: 03/16/2022

Desc: Medical Face Mask

80 M - - SH Respirator, surgical
Date Published: 03/16/2022

Desc: Medical Face Mask

80 M - - SH Respirator, surgical
Date Published: 03/16/2022

Desc: Sterile Surgical Mask

80 M - - SH Respirator, surgical
Date Published: 03/16/2022

Desc: KN95 Face Mask

80 N - - ZJ Respirator, n95, home use
Date Published: 03/16/2022

Desc: KN95 Face Mask

ZHENGZHOU FORTUNE BIOSCIENCE CO. Ltd
Date Published : 06/22/2020
East Wansan Road,North Shangdu Street , (Fangxin Industrial Park) East Wansan Road,North Shangdu Street, Zhongmou County , Zhengzhou, Henan CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: COVID-19 IgM Antibody Rapid Test Kit

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: COVID-19 IgG Antibody Rapid Test Kit

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: COVID-19 IgM Antibody Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: COVID-19 IgG Antibody Rapid Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: COVID-19 IgM Antibody Rapid Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: COVID-19 IgG Antibody Rapid Test Kit

ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.
Date Published : 11/29/2023
West Industrial Park, BDA, Luannan County , Tangshan City, Hebei CHINA
80 F - - MC Glove, Patient Examination
Date Published: 11/29/2023

Desc: Nitra-Med Heavy Powder Free Nitrile Exam Gloves
Notes:                                                                                                                                                                                                                                                                

80 L - - YY Glove, Patient Examination, Latex
Date Published: 11/29/2023

Desc: Nitra-Med Heavy Powder Free Nitrile Exam Gloves
Notes:                                                                                                                                                                                                                                                                

80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 11/29/2023

Desc: Nitra-Med Heavy Powder Free Nitrile Exam Gloves
Notes:                                                                                                                                                                                                                                                                

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 11/29/2023

Desc: Nitra-Med Heavy Powder Free Nitrile Exam Gloves
Notes:                                                                                                                                                                                                                                                                

80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 11/29/2023

Desc: Nitra-Med Heavy Powder Free Nitrile Exam Gloves
Notes:                                                                                                                                                                                                                                                                

ZHONGSHAN QUANDE ELECTRIC FACTORY
Date Published : 07/11/2011
TANBEI INDUSTRIAL ZONE , TANBEL YUANXING ROAD, DONGSHENG , Zhongshan, CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 07/11/2011

Desc: SL-50 Cluster Laser
Notes: Class II

79 O - - NF Powered light based non-laser surgical instrument with thermal effect
Date Published: 07/11/2011

Desc: SL-50 Cluster Laser
Notes: Class II

84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Electric Acupuncture Pen
Notes: Class II

89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy
Date Published: 07/11/2011

Desc: SL-50 Cluster Laser
Notes: Class II

ZHUHAI KEYU BIOLOGICAL ENGINEERING
Date Published : 10/21/2020
D Building F 2 , No. 288 Dong Bypass; Jinwan Districtr , Zhuhai, Guangdong CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/21/2020

Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/21/2020

Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/21/2020

Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/21/2020

Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test

ZHUHAI LITUO BIOTECHNOLOGY CO.,LTD
Date Published : 05/28/2021
No. 35 Jinwan District , Yongan Three Road, Hongqi Town , Zhuhai, Guangdong CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/28/2021

Desc: COVID-19 Antigen Detection Kit (Collodial Gold)

ZHUHAI LIVZON DIAGNOSTICS Inc
Date Published : 07/17/2020
No. 266 Tongchang Road , Zhuhai, Guangdong CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/25/2021

Desc: COVID-19 Diagnostic Kit for IgM/IgG Antibody to Corona Virus (nCoV-2019)(Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/23/2021

Desc: Livzon Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)

Zhangjiagang Fengyuan Plastic Products Co., Ltd.
Date Published : 02/23/2024
No. 333, Fumin Middle Road , Tangqiao town , Zhangjiagang City,, Jiangsu CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/23/2024

Desc: Nitrile Patient Examination Gloves
Notes:                                                                  

Zhangjiagang Jiamei Rubber Product Co. Ltd
Date Published : 10/09/2015
No. 85 Shuanglong Road , Fenghuangzhen Zhangjiagang , Suzhou, Jiangsu CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/05/2020

Desc: Black Lightning Powder Free Nitrile Examination Gloves pH 5.5 (sizes M L XL XXL)
Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/05/2020

Desc: Megaman Powder-Free Black Nitrile Flock-Lined Examination Gloves (size XXL)
Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. Only size XXL is subject to the alert.

Zhangjiangang Yayang International Co., Ltd.
Date Published : 11/19/2015
No. 3 Jinxiu Road Jinfeng Town , Zhangjiagang City, CHINA
89 L - - YG Massager, Therapeutic, Manual
Date Published: 11/19/2015

Desc: BODY BACK STICKS - PLASTIC MANUAL MASSAGERS
Notes: The device has no 510(k) clearance

Zhejiang Medicines & Health Products Import & Export Co. Ltd
Date Published : 06/02/2011
21 Chuxin Road , Hangzhou, Zhejiang CHINA
87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 01/30/2019

Desc: Portable Smart Massage U Disc Tens Unit
Notes: Class II; 6/2/2011

Zhejiang Orient Gene Biotech
Date Published : 05/28/2021
Ji Er Road Jiankang Industrial Area , Anji Economic Development Zone , Zhejiang, CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 02/10/2023

Desc: COVID-19 Antigen

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/28/2021

Desc: COVID-19 Antigen

83 Q - - LW COVID-19 test home collection kit devices
Date Published: 02/10/2023

Desc: COVID-19 Antigen

Zhejiang Quark Biotechnology Co., Ltd
Date Published : 03/11/2021
Zhejiang Xinchang High-Tech Ind. Park, Xinchang , 1 Jiang East Rd; Diankouzhen Zhuji , Shaoxing, Zhejiang CHINA
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: C-19 Quik Test

Zhong Chen Beauty Supplies
Date Published : 07/13/2012
4th Fl. Zhida Industry Longping Rd , Longgang Shenzhenlonggang Shenzhen, CHINA
73 - - - -- Anesthesiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

74 - - - -- Cardiovascular
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

76 - - - -- Dental
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

77 - - - -- Ear,Nose And Throat
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

78 - - - -- Gastroenterological & Urological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

79 - - - -- General & Plastic Surgery
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

80 - - - -- General Hospital/Personal Use
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

84 - - - -- Neurological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

85 - - - -- Obstetrical & Gynecological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

86 - - - -- Ophthalmic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

87 - - - -- Orthopedic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

89 - - - -- Physical Medicine
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

90 - - - -- Radiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

Zhong Shan Native Produce
Date Published : 08/26/2010
Bai Shi Huan Huan Cheng , Zhongsha, Guangdong CHINA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/26/2010

Desc: Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand)
Notes: Class III

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/26/2010

Desc: Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand)
Notes: Class III

Zhong Shan Syou Ei Beauty Instrument Co., Ltd.
Date Published : 08/26/2010
Longjing Fang Industrial Estate , Chang Ming Shui, Wu Gui Shan , Zhong Shan, Guang Dong CHINA
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/07/2015

Desc: OXYGEN FACIAL PURIFIER
Notes: Problem(s); Lacks 510(k)

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/26/2010

Desc: Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand)
Notes: Class III

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/26/2010

Desc: Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand)
Notes: Class III

Zhongshan Bisen Plastic Electronic Products Co., Ltd.
Date Published : 08/09/2021
2nd Fl, A bldg, No. 32 Jianye Rd , Torch Development Zone , Zhongshan, CHINA
79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 08/09/2021

Desc: Vega Light Therapy Device
Notes:                                                                                                                                                                                                                                                                                                                                                  

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 08/09/2021

Desc: Jupiter Light Therapy Device
Notes:                                                                                                                                                                                                                                                                                                                                                  

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 08/09/2021

Desc: Neptune Light Therapy Device
Notes:                                                                                                                                                                                                                                                                                                                                                  

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 08/09/2021

Desc: Jupiter Light Therapy Device
Notes:                                                                                                                                                                                                                                                                                                                                                  

Zhuhai Encode Medical Engineering Co., Ltd
Date Published : 06/22/2020
No 20 Honghui Road , Liangang Gongye Xiaolinzhen Jinwan , Zhuhai, Guangdong CHINA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device

83 Q - - KO Reagent, coronavirus serological
Date Published: 12/23/2020

Desc: Boston Bio EZ COVID-19

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/25/2021

Desc: SARS-CoV-2 IgG/IgM Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device

Zhuhai Haishen Import Export Co. Ltd
Date Published : 07/21/2017
161 Summer Beauty Rd , Zhuhai, Guangdong CHINA
84 H - - ST Apparatus, traction, non-powered
Date Published: 11/08/2018

Desc: Chisoft Neck Stretcher

Zhuzhou Lusong District Hui Tao Electronic Commerc
Date Published : 11/03/2016
Carsem Villas NO.1607 , NO. 158 Sports Rd , Zhuzhou, CHINA
90 M - - UJ System, Planning, Radiation Therapy Treatment
Date Published: 11/03/2016

Desc: Dr. Fargo Photon Energy Detoxification Bag
Notes: Class II Device (may be a Class III). The device claims made are varied and the mechanism of technology of the device is and it is unclear how the device produces the intended effects are unclear. CDRH is not aware of any predicate devices that the manufacturer may compare to for 510(k) submission. Therefore; there is no specific product code or regulation that applies to this device since there are no known predicate device(s).


COLOMBIA


C.I. Expotextiles Y Confecciones
Date Published : 07/23/2010
Cra 78f No.0-33 Int. 15 Apto. 302 , Bogota, COLOMBIA
80 D - - WL Stocking, Medical Support
Date Published: 07/23/2010

Desc: Body Shaper
Notes: "Lipo Illusion" Compression Garment; Class II

SKIN DERMOTHERAPIES
Date Published : 03/24/2017
Carrera 20 158 - 40 , Bucaramanga, Santander COLOMBIA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/24/2017

Desc: Skin Dermo Therapies Kit
Notes: Class I


CURACAO


Metradco MV
Date Published : 03/08/2011
Unknown Street , Curacao, CURACAO
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Stimulator Electro-Acupuncture
Notes: Class III


CZECH REPUBLIC


Ela Moravia
Date Published : 06/23/2011
Polanka 60/18 , Starecka, Vysocina CZECH REPUBLIC
80 D - - WL Stocking, Medical Support
Date Published: 06/23/2011

Desc: Medical Support Stockings
Notes: Class II

RESPILON E-COMMERCE SRO
Date Published : 08/24/2022
Prikop 843/4 , Brno, CZECH REPUBLIC
80 F - - XX Mask, Surgical
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 M - - SH Respirator, surgical
Date Published: 08/24/2022

Desc: RespiPro Respirator

80 M - - SH Respirator, surgical
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 N - - ZJ Respirator, n95, home use
Date Published: 08/24/2022

Desc: RespiPro Respirator

80 N - - ZJ Respirator, n95, home use
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 Q - - KR Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 Q - - KR Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance
Date Published: 08/24/2022

Desc: RespiPro Respirator

80 Q - - KU Non-NIOSH-approved Disposable Filtering Facepiece Respirators (FFRs)
Date Published: 08/24/2022

Desc: RespiPro Respirator

80 Q - - KU Non-NIOSH-approved Disposable Filtering Facepiece Respirators (FFRs)
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 Q - - OZ Barrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Publ
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 Q - - OZ Barrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Publ
Date Published: 08/24/2022

Desc: RespiPro Respirator

RESPILON GROUP SRO
Date Published : 10/31/2022
Jaselska 197/14 , Brno 2, CZECH REPUBLIC
80 F - - XX Mask, Surgical
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 M - - SH Respirator, surgical
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 N - - ZJ Respirator, n95, home use
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 Q - - KR Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 Q - - KU Non-NIOSH-approved Disposable Filtering Facepiece Respirators (FFRs)
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

80 Q - - OZ Barrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Publ
Date Published: 10/31/2022

Desc: Self Sterilizing FFP2 Nano Respirator

WAKE SPOL. S.R.O.
Date Published : 11/14/2011
Arbesova 797/3 , Plzenske Predmesti, Plzensky CZECH REPUBLIC
79 N - - AE Dressing, Wound, Hydrogel
Date Published: 11/14/2011

Desc: Would Be Gone Wound Healing Gel
Notes: Class I

Wake Pharma S.R.O.
Date Published : 11/14/2011
Srobarova 1869/14 , 10 , Prague 101, None of the above CZECH REPUBLIC
79 N - - AE Dressing, Wound, Hydrogel
Date Published: 11/14/2011

Desc: Would Be Gone Wound Healing Gel
Notes: Class I

Wake Pharma, S.R.O.
Date Published : 11/14/2011
Smilovskeho 1264/5 , Praha, CZECH REPUBLIC
79 N - - AE Dressing, Wound, Hydrogel
Date Published: 11/14/2011

Desc: Would Be Gone Wound Healing Gel
Notes: Class I


DENMARK


4dimens Aps
Date Published : 03/28/2012
Jyllingehoej 2 , Jyllingejyllinge, DENMARK
79 F - - ZD Prosthesis, Ear, Internal
Date Published: 03/28/2012

Desc: Auri Kit; Clamp ear pinning kit
Notes: class II

79 H - - XD Clamp
Date Published: 03/28/2012

Desc: Auri Kit; Clamp ear pinning kit
Notes: Class II

Camilla Noenygaard
Date Published : 06/08/2011
Maglebjergvej 4 , Kgs Lyngby, DENMARK
78 L - - KY Device, External Penile Rigidity
Date Published: 06/08/2011

Desc: Penile Extender
Notes: Class II

78 N - - HU Extender, Penile, Mechanical
Date Published: 06/08/2011

Desc: Penile Extender
Notes: Class II

Danalife ApS
Date Published : 05/30/2023
Maglebjergvej 4 , Lyngby, DENMARK
78 L - - KY Device, External Penile Rigidity
Date Published: 05/30/2023

Desc: Penile Extender

Danamedic Aps
Date Published : 09/16/2009
Maglebjergvej 1a , 4, Bostamose O Strade , Kgs. Lyngby, Hovedstaden DENMARK
78 L - - KY Device, External Penile Rigidity
Date Published: 09/16/2009

Notes: Jes-Extender (penis extending device)12/18/2006

78 N - - HU Extender, Penile, Mechanical
Date Published: 09/16/2009

Notes: Jes-Extender (penis Extending Device 12/18/2006

Sorribes Online
Date Published : 03/28/2012
Jyllingehoj 2 , Jyllinge, DENMARK
79 F - - ZD Prosthesis, Ear, Internal
Date Published: 03/28/2012

Desc: Auri Kit; clamp ear pinning kit
Notes: class II

79 H - - XD Clamp
Date Published: 03/28/2012

Desc: Auri Kit; clamp ear pinning kit
Notes: Class II


ESTONIA


Kokkonen Ou
Date Published : 01/21/2014
Kasvu 16-18 , Tallinn, ESTONIA
80 - - - -- General Hospital/Personal Use
Date Published: 11/08/2018

Desc: Saltarium Salt Cocoon
Notes: Class II

Parasym OU
Date Published : 09/11/2023
Majaka 26, 11412 , Tallinn, ESTONIA
73 B - - XM Stimulator, Nerve, Ac-Powered
Date Published: 09/11/2023

Desc: NUROSYM

79 M - - DM Instrument, Manual, General Surgical
Date Published: 09/11/2023

Desc: NUROSYM

84 L - - YJ Stimulator, Autonomic Nerve, Implanted for Epilepsy
Date Published: 09/11/2023

Desc: NUROSYM

84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 09/11/2023

Desc: NUROSYM

84 P - - KR Non-invasive vagus nerve stimulator - headache
Date Published: 09/11/2023

Desc: NUROSYM

SkandiaLife Manufacturing
Date Published : 09/29/2009
Varbola Kula, Marjamaa Vald , Raplamaa, ESTONIA
89 I - - MB Cabinet, Moist Steam
Date Published: 01/30/2019

Desc: Sybaritic Inc. (Sybaritic) Hydration Station
Notes: Class II; 9/1/2009


FINLAND


ARCDIA INTERNATIONAL OY LTD
Date Published : 06/22/2021
Lemminkaisenkatu 32 Pl , Turku, FINLAND
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: ArcDia mariPOC SARS CoV2

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: mariPOC SARS-CoV-2 by ArcDia international Oy Ltd

Labsystems Oy (Farmos Diag.)
Date Published : 09/16/2009
Pulttitie 8 , Helsinki, FINLAND
89 - - - -- Physical Medicine
Date Published: 09/16/2009

Notes: Tetanus IgG EIA Kit

WALLAC OY_PPERKINELMER
Date Published : 03/11/2021
Mustionkatu 6 , MUSTIONKATU 6 , Turku, Southwest Finland FINLAND
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: GSP/DELFIA Anti-SARS-CoV-2 IgG Kit


FRANCE


A & S Biovecteurs
Date Published : 12/17/2018
10 Av De L'Europe , Ramonville St. Agnes, FRANCE
73 - - - -- Anesthesiology
Date Published: 12/17/2018

74 - - - -- Cardiovascular
Date Published: 12/17/2018

76 - - - -- Dental
Date Published: 12/17/2018

77 - - - -- Ear,Nose And Throat
Date Published: 12/17/2018

78 - - - -- Gastroenterological & Urological
Date Published: 12/17/2018

79 - - - -- General & Plastic Surgery
Date Published: 12/17/2018

80 - - - -- General Hospital/Personal Use
Date Published: 12/17/2018

84 - - - -- Neurological
Date Published: 12/17/2018

85 - - - -- Obstetrical & Gynecological
Date Published: 12/17/2018

86 - - - -- Ophthalmic
Date Published: 12/17/2018

87 - - - -- Orthopedic
Date Published: 12/17/2018

89 - - - -- Physical Medicine
Date Published: 12/17/2018

90 - - - -- Radiology
Date Published: 12/17/2018

ABLD
Date Published : 11/24/2021
33 Chemin De L'Argile , Marseille, Bouches du Rhone FRANCE
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: UltraGene Combo2Screen SARS-CoV-2 assay

BIOSPEEDIA SAS
Date Published : 08/30/2021
25 Rue Du Docteur Roux , Paris, Paris FRANCE
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: COVID19 Speed Test Strip

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: COVID19SEROSpeed-lgM-lgG Rapid IgG/IgM Test

BIOSYNEX
Date Published : 04/20/2022
22 Boulevard Sebastien Brant , Illkirch Graffenstaden, Bas Rhin FRANCE
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2022

Desc: Biosynex COVID19 BSS

Burnet Laboratoire Pharmaceutique
Date Published : 09/16/2009
El Medico Chirurgical , 56 avenue de la Republique , La Ferte Bernard, Sarthe FRANCE
80 K - - GO Surgeon's Gloves
Date Published: 11/08/2018

Desc: Sterile Surgical Gloves

Cgb Alpheratz
Date Published : 04/27/2018
21 Des Tourrades , Mandelieu, FRANCE
79 O - - NE Powered light based non-laser surgical instrument
Date Published: 04/27/2018

Desc: DualChroma/Chromapuncteur-10
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/27/2018

Desc: DualChroma/Chromapuncteur-10
Notes: Class II

Chauvin Opsia Sa
Date Published : 09/16/2009
Rue Max Planck , Bp 711 , Labege CEDEX, FRANCE
86 L - - WL Fluid, Intraocular
Date Published: 09/16/2009

Notes: Oxane; Purified Silicone Oil (Intraocular Fluid for Retinal Re-attachment) 5/31/2001

Firalis
Date Published : 11/24/2021
35 Rue Du Fort , Huningue, FRANCE
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: EasyCOV

I.MANAGEMENT
Date Published : 08/02/2023
80 Rue Curial , Paris, Paris FRANCE
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/02/2023

Desc: Skeen Patch

84 G - - XY Electrode, Cutaneous
Date Published: 08/02/2023

Desc: Skeen Patch

84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 08/02/2023

Desc: Skeen Patch

89 I - - SA Massager, Therapeutic, Electric
Date Published: 08/02/2023

Desc: Skeen Patch

Kappa City Biotech SAS
Date Published : 01/24/2018
32 Rue Danton , Montlucon, Allier FRANCE
91 M - - GX Test System, for Drugs of Abuse
Date Published: 01/24/2018

Desc: Urine Test Strip

Laboratoire Nycomed Ingenor Sa
Date Published : 09/16/2009
25 Quai De La Gare , Paris, Paris FRANCE
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Laboratoires Eurosilicone
Date Published : 09/16/2009
21 Rue Francis Combe , Cergy Pontoise, FRANCE
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE. 12/28/1994

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Movmedix S.A.S
Date Published : 09/16/2009
5 Rue De La Fontaine , Arc Sur Tille, Bourgogne-Franche-Comte FRANCE
87 L - - ML Ligaments And Tendons, Synthetic
Date Published: 09/16/2009

Notes: LARS (Ligament Advanced Reinforcement System) 10/13/1995

Orthomed
Date Published : 09/16/2009
256 rue Dardelain , Marsannay la Cote, Cote d'Or FRANCE
87 L - - ML Ligaments And Tendons, Synthetic
Date Published: 09/16/2009

Notes: Ligastic Artificial Ligaments. 10/13/1995

ProCytech S.A.S.
Date Published : 09/16/2009
4 rue Jacques Monod , Technopole Montesquieu , Martillace, FRANCE
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 09/16/2009

Notes: 8/26/2003 Outline Ultra A Bioresorbable Polycrylamide Filler for Soft Tissue.

SAPP
Date Published : 09/16/2009
#4 Rue Cozette , Amiens, FRANCE
76 M - - GE Hearing-Aid, Audiodontic
Date Published: 09/16/2009

Notes: Audiokinetron Device. 3/29/1994.

Sorin CRM SAS
Date Published : 09/16/2009
Cvk , Acmo Parc; 10 Avenue Reaumur , Clamart Cedex, Hauts de Seine FRANCE
74 D - - RO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Date Published: 09/16/2009

Notes: 9/9/1992 Chorus RM cardia pacemaker model 7023. Chorus II cardia pacemaker model 6234

TH SA
Date Published : 09/16/2009
32, CHEMIN DE LA VIOLETTE , 31240 L'UNION, FRANCE
87 H - - TM Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive, Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
Date Published: 11/08/2018

Notes: Presso Dan 207 Pressure therapy apparatus 8/02/01

Tomatis Electronics
Date Published : 09/16/2009
56 Rue Des Batignolles , Paris, FRANCE
84 G - - WJ Stimulator, Auditory, Evoked Response
Date Published: 09/16/2009

Notes: Electronic Ear; or any device labeled or marked for auditory training; auditory integration or behavioral improvement.

Tomatis International
Date Published : 09/16/2009
6, Place de la Republique-Dominicaine , Paris, FRANCE
84 G - - WJ Stimulator, Auditory, Evoked Response
Date Published: 09/16/2009

Notes: Electronic Ear or any deviced labled or marked for auditory training; auditory integration; or behavioral improvement. 2/5/1997

Veda Lab
Date Published : 04/20/2021
Rue De L'Expansion , Alancon, Cedex FRANCE
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2021

Desc: COVID-19-CHECK-1


GERMANY


ACTIV CARE TRANSCON GMBH
Date Published : 05/30/2017
Zur Larche 53 , Nettetal, North Rhine-Westphalia GERMANY
74 M - - SX System, Network and Communication, Physiological Monitors
Date Published: 05/30/2017

Desc: BioScan SWA Skalar-Wave Analyzer
Notes: Class II device without a valid 510k

84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 05/30/2017

Desc: BioScan SWA Skalar-Wave Analyzer
Notes: Class II device without a valid 510k

ARCERA GMBH
Date Published : 06/12/2023
Levelingstr. 8 , Munich, Bavaria GERMANY
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 06/12/2023

Desc: Intraarticular hyaluronic acid; EUFLEXXA
Notes:                                                                  

Aesku Group GmbH & Co. KG
Date Published : 01/29/2021
Mikro-Forum-Ring 2 , Wendelsheim, Rhineland-Palatinate GERMANY
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/29/2021

Desc: AESKULISA? SARS-CoV-2 NP IgM

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/29/2021

Desc: AESKULISA SARS-CoV-2 S1 IgG

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/29/2021

Desc: AESKULISA SARS-CoV-2 S1 IgM

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/29/2021

Desc: AESKULISA SARS-CoV-2 NP IgG

Avalign German Specialty Instruments Division
Date Published : 08/28/2014
Unter Buchsteig 3 , Tuttlingen, Baden-Wurttemberg GERMANY
74 D - - RC Trocar
Date Published: 08/28/2014

Desc: Thoracic Trocar
Notes: Class 2

74 M - - GZ Valvulotome
Date Published: 08/28/2014

Desc: Valvulatome
Notes: Class 2

84 H - - AX Tong, Skull for Traction
Date Published: 08/28/2014

Desc: Traction Tongs
Notes: Class 2

84 H - - BG Drills, Burrs, Trephines & Accessories (Manual)
Date Published: 08/28/2014

Desc: Hudson Burr 14mm; (Item# VM NL2SO)
Notes: Class 2

84 H - - BG Drills, Burrs, Trephines & Accessories (Manual)
Date Published: 08/28/2014

Desc: Clamping Device with Ball and Socket (Item# VM NLISO)
Notes: Class 2

84 H - - BG Drills, Burrs, Trephines & Accessories (Manual)
Date Published: 08/28/2014

Desc: Adson Perforating Bur; 14mm (Item# VM NL190)

84 H - - BG Drills, Burrs, Trephines & Accessories (Manual)
Date Published: 08/28/2014

Desc: McKenzie Perforating Twist Drill; 13mm (Item# VMNL200)
Notes: Class 2 ;

84 H - - BG Drills, Burrs, Trephines & Accessories (Manual)
Date Published: 08/28/2014

Desc: McKenzie Enlarging Burr; 16mm (Item# VM NL270)
Notes: Class 2

84 H - - BG Drills, Burrs, Trephines & Accessories (Manual)
Date Published: 08/28/2014

Desc: Hudson Burr; 12mm; 8 teeth; tapered (Item# VM NL180)
Notes: Class 2 ;

85 H - - DC Tenaculum, Uterine
Date Published: 08/28/2014

Desc: Uterine Tenaculum Hook
Notes: Class 2

85 H - - DC Tenaculum, Uterine
Date Published: 08/28/2014

Desc: Uterine Tenaculum Forceps
Notes: Class 2

85 H - - FX Clamp, Circumcision
Date Published: 08/28/2014

Desc: Endometrium
Notes: Class 2

85 H - - FX Clamp, Circumcision
Date Published: 08/28/2014

Desc: Circumcision Clamps
Notes: Class 2

Binder Gmbh
Date Published : 09/16/2009
P.O. Box 102 , Tuttlingen, GERMANY
84 H - - CC Device, Biofeedback
Date Published: 09/16/2009

Notes: Ondamed System Regulation Biofeedback Device 4/29/2003

Binder International
Date Published : 09/16/2009
Otto-Hahn-Str. 19 , Herrenberg, Baden-Wurttemberg GERMANY
84 H - - CC Device, Biofeedback
Date Published: 09/16/2009

Notes: Ondamned System Regulation (Biofeedback Device) 4/29/2003 Lack of 510(k) Approval.

Bosch Healthcare Solutions GmbH
Date Published : 09/30/2021
Stuttgarter Str. 130 , Waiblingen, Baden-Wurttemberg GERMANY
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: Vivalytic VRI

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: Vivalytic Viral Respiratory tract Infections

Brain Products Gmb
Date Published : 12/17/2010
Zeppelinstrasse 7 , Gilching, GERMANY
84 N - - BD Stimulator, Cranial, Magnetic Pulse (for brain mapping and function studies)
Date Published: 12/17/2010

Desc: Brain Amps
Notes: Class II

CHEMBIO DIAGNOSTICS GMBH
Date Published : 08/31/2021
Schwarzschildstr. 1 , Berlin, Berlin GERMANY
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: DPP SARS CoV-2 IgM/IgG with DPP Micro Reader II

DERMAROLLER GMBH
Date Published : 03/13/2013
Lindener Str. 15 , Wolfenbuttel, Lower Saxony GERMANY
73 - - - -- Anesthesiology
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

74 - - - -- Cardiovascular
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

76 - - - -- Dental
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

77 - - - -- Ear,Nose And Throat
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

78 - - - -- Gastroenterological & Urological
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

79 - - - -- General & Plastic Surgery
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

80 - - - -- General Hospital/Personal Use
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

84 - - - -- Neurological
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

85 - - - -- Obstetrical & Gynecological
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

86 - - - -- Ophthalmic
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

87 - - - -- Orthopedic
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

89 - - - -- Physical Medicine
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

90 - - - -- Radiology
Date Published: 03/13/2013

Notes: All Devices;class I/II/III

DRG Instruments GmbH
Date Published : 10/25/2017
Frauenbergstr. 18 , Marburg, Hassia GERMANY
75 N - - HG Enzyme Immunoassay, Cortisol, Salivary
Date Published: 10/25/2017

Desc: Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA
Notes:                                                                                          

Demask Dortmund
Date Published : 03/01/2011
44135 Dortmund , Hamburger Str. 120 , Dortmund, North Rhine-Westphalia GERMANY
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 03/01/2011

Desc: Pocket Darkroom Contact Lenses
Notes: Class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 03/01/2011

Desc: Pocket Darkroom Contact Lenses
Notes: Class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 03/01/2011

Desc: Pocket Darkroom Contact Lenses
Notes: Class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 03/01/2011

Desc: Pocket Darkroom Contact Lenses
Notes: Class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 03/01/2011

Desc: Pocket Darkroom Contact Lenses
Notes: Class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 03/01/2011

Desc: Pocket Darkroom Contact Lenses
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 03/01/2011

Desc: Pocket Darkroom Contact Lenses
Notes: Class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 03/01/2011

Desc: Pocket Darkroom Contact Lenses
Notes: Class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 03/01/2011

Desc: Pocket Darkroom Contact Lenses
Notes: Class II

Gbo Medizin Tec
Date Published : 03/09/2012
Litzel Rimbach , Rimbach, Hessen GERMANY
84 N - - HI Nerve, Stimulator, Electrical, Percutaneous (PENS) for Pain Relief
Date Published: 03/09/2012

Desc: Quantron Resonance System (Body Stimulator)
Notes: class II

Genzyme Virotech Gmbh
Date Published : 01/26/2021
Lowenplatz 5 , Russelsheim Am Main, Hassia GERMANY
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/19/2022

Desc: SARS-CoV-2 IgG ELISA Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit

Gerbion Gmbh
Date Published : 06/08/2022
Remsstr. 1 , Kornwestheim, Baden-Wurttemberg GERMANY
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: VirellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0

INSTITUTE DR. RILLING INC.
Date Published : 05/30/2017
Lilienthalweg 13 , Pliezhausen, GERMANY
74 M - - SX System, Network and Communication, Physiological Monitors
Date Published: 05/30/2017

Desc: BioScan SWA Skalar-Wave Analyzer
Notes: Class II device without a valid 510k

84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 05/30/2017

Desc: BioScan SWA Skalar-Wave Analyzer
Notes: Class II device without a valid 510k

Institut Virion/Serion Gmbh
Date Published : 08/30/2021
Friedrich-Bergius-Ring 19 , Wurzburg, Bavaria GERMANY
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: SERION ELISA agile SARS-CoV-2 IgG

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: SERION ELISA agile SARS COV-2 IgA

Kendall Ltd.
Date Published : 09/16/2009
Raffineriestr. 8 , Neustadt, GERMANY
73 B - - RY Cabinet, Table And Tray, Anesthesia
Date Published: 09/16/2009

Notes: Spinal Anethesia Tray; COSPAN Continuous Spinal Anesthesia Tray; COSPAN Pediatric Spinal Anesthesia Tray; Curity Pediatric Continuous Spinal Anesthesia Tray.

Leibinger GMBH
Date Published : 09/16/2009
Schutzenstrabe 5-7 , Tuttlingen, GERMANY
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. Total Joint or Condylar protheses for the Temporomandibular joint (TMJ) 4/16/1993. US Distributer                                                                  

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

MEDSAN GMBH
Date Published : 07/07/2020
Brandshofer Deich 10 , Hamburg, Hamburg GERMANY
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/07/2020

Desc: MEDSAN COVID-19 IgM/IgG RAPID TEST

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/07/2020

Desc: MEDSAN COVID-19 IgM/IgG RAPID TEST

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/07/2020

Desc: MEDSAN COVID-19 IgM/IgG RAPID TEST

Megasol Cosmetic GmbH
Date Published : 01/08/2013
Jean-Monnet-Str. 6 , Fohren, Rhineland-Palatinate GERMANY
85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible
Date Published: 01/08/2013

Desc: EROS Brand Cosmetic Gels personal lubricants
Notes: Class II

Mlase Ag
Date Published : 10/16/2015
Industriestr 17 , Germering, GERMANY
79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/16/2015

Desc: CCL Vario Demo For Trade Show
Notes:                                                                                                                                                                                                                                 

79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/16/2015

Desc: CCL Vario Demo Unit
Notes:                                                                                                                                                                                                                                   

79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/16/2015

Desc: CCL 365 Corneal Cross-Linking System
Notes:                                                                                                                                                                                                                                 

79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/16/2015

Desc: CCL 365 Vario Ultraviolet Lamp;
Notes:                                                                                                                                                                                                                                   

79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/16/2015

Desc: Phoenix Demo for Trade Show
Notes:                                                                                                                                                                                                                                 

79 R - - EG Suntan lamp
Date Published: 01/23/2019

Desc: UV-Lamp for Animal Use
Notes:                                                                                                                                                                                                                                   

79 R - - EG Suntan lamp
Date Published: 01/23/2019

Desc: UV Lamp
Notes:                                                                                                                                                                                                                                 

86 H - - RJ Table, Instrument, Powered, Ophthalmic
Date Published: 10/16/2015

Desc: Phoenix Demo for Trade Show
Notes:                                                                                                                                                                                                                                 

86 H - - RJ Table, Instrument, Powered, Ophthalmic
Date Published: 10/16/2015

Desc: CCL Vario Demo Unit
Notes:                                                                                                                                                                                                                                 

86 H - - RJ Table, Instrument, Powered, Ophthalmic
Date Published: 10/16/2015

Desc: CCL 365 Vario Ultraviolet Lamp
Notes:                                                                                                                                                                                                                                 

86 H - - RJ Table, Instrument, Powered, Ophthalmic
Date Published: 10/16/2015

Desc: CCL 365 Corneal Cross-Linking System
Notes:                                                                                                                                                                                                                                 

86 H - - RJ Table, Instrument, Powered, Ophthalmic
Date Published: 10/16/2015

Desc: CCL Vario Demo For Trade Show
Notes:                                                                                                                                                                                                                                 

86 N - - FJ System, Image Management, Ophthalmic
Date Published: 10/16/2015

Desc: CCL 365 Corneal Cross-Linking System
Notes:                                                                                                                                                                                                                                   

86 N - - FJ System, Image Management, Ophthalmic
Date Published: 10/16/2015

Desc: CCL 365 Vario Ultraviolet Lamp
Notes:                                                                                                                                                                                                                                   

86 N - - FJ System, Image Management, Ophthalmic
Date Published: 10/16/2015

Desc: Phoenix Demo for Trade Show
Notes:                                                                                                                                                                                                                                   

86 N - - FJ System, Image Management, Ophthalmic
Date Published: 10/16/2015

Desc: CCL Vario Demo Unit
Notes:                                                                                                                                                                                                                                   

86 N - - FJ System, Image Management, Ophthalmic
Date Published: 10/16/2015

Desc: CCL Vario Demo For Trade Show
Notes:                                                                                                                                                                                                                                   

95 R - - HW Uv lamp for home or business uses
Date Published: 10/16/2015

Desc: UV-Lamp for Animal Use
Notes:                                                                                                                                                                                                                                   

95 R - - HW Uv lamp for home or business uses
Date Published: 10/16/2015

Desc: UV Lamp
Notes:                                                                                                                                                                                                                                   

Mt.Derm Gmbh
Date Published : 10/02/2015
Gustav-Krone-Str. 3 , Berlin, Berlin GERMANY
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 04/24/2017

Desc: Microneedling device
Notes: Class II

79 G - - AR Suture, Nonabsorbable, Synthetic, Polyamide
Date Published: 10/02/2015

Desc: Microneedling device
Notes: Class II

79 G - - ED Brush, Dermabrasion, Manual
Date Published: 10/02/2015

Desc: Microneedling device
Notes: Class II

79 G - - FE Brush, Dermabrasion
Date Published: 04/24/2017

Desc: Microneedling device
Notes: Class II

Nal Von Minden Gmbh
Date Published : 08/30/2021
Carl-Zeiss-Str. 12 , Moersmoers, GERMANY
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: NADAL COVID-19 IgG/IgM Test

Nal Von Minden Gmbh
Date Published : 08/30/2021
9 Carl-Peschken-Strasse , Moers, Nordrhein-westfalen GERMANY
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: NADAL COVID-19 IgG/IgM Test

Novafon Elektromedizinche Gerate Gmbh (aka Novafon Gmbh)
Date Published : 09/16/2009
unknown , Stuttgart, GERMANY
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: DE = Nostrafon SK2 Sound Wave Appliance. Medi-Pol (magnetic field therapy used as an accessory device with Nostrafon Unit).

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Nu Life Enterprise Ltd. & Co.
Date Published : 09/16/2009
Arnikastr. 2 , Hohenkirchen-Siegertsbrunn, Bavaria GERMANY
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 09/16/2009

Notes: 3/5/2009 miniZAP Blood Zapper

Ondamed GmBH
Date Published : 09/16/2009
Kurzeller Str. 18 , Schwanau, Baden-Wurttemberg GERMANY
84 H - - CC Device, Biofeedback
Date Published: 09/16/2009

Notes: Ondamed System Regulation Biofeedback Device 4/29/2003

Orion Versand Gmbh & Co.
Date Published : 07/14/2010
Schaferweg 14 , Flensburg, GERMANY
85 H - - GX Pump, Breast, Powered
Date Published: 07/14/2010

Desc: Breast Pump
Notes: Class II

PFM Medical Titanium GmbH
Date Published : 03/20/2017
Sudwestpark 42 , Nuremberg, Bavaria GERMANY
79 F - - TL Mesh, Surgical, Polymeric
Date Published: 03/20/2017

Desc: TiLENE Plug Set (surgical mesh)
Notes: Class II device without 510k

79 F - - TL Mesh, Surgical, Polymeric
Date Published: 03/20/2017

Desc: TiLENE Guard Set (surgical mesh)
Notes: Class II device without 510k

79 F - - TL Mesh, Surgical, Polymeric
Date Published: 03/20/2017

Desc: TiLENE Strip (surgical mesh)
Notes: Class II device without 510k

79 F - - TL Mesh, Surgical, Polymeric
Date Published: 03/20/2017

Desc: TiLENE Guard (surgical mesh)
Notes: Class II device without 510k

79 F - - TL Mesh, Surgical, Polymeric
Date Published: 03/20/2017

Desc: TiSURE (surgical mesh)
Notes: Class II device without 510k

79 F - - TL Mesh, Surgical, Polymeric
Date Published: 03/20/2017

Desc: TiLENE Plug (surgical mesh)
Notes: Class II device without 510k

79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects
Date Published: 03/20/2017

Desc: TiLENE Plug Set (surgical mesh)
Notes: Class II device without 510k

79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects
Date Published: 03/20/2017

Desc: TiLENE Guard Set (surgical mesh)
Notes: Class II device without 510k

79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects
Date Published: 03/20/2017

Desc: TiLENE Guard (surgical mesh)
Notes: Class II device without 510k

79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects
Date Published: 03/20/2017

Desc: TiLENE Plug (surgical mesh)
Notes: Class II device without 510k

79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects
Date Published: 03/20/2017

Desc: TiSURE (surgical mesh)
Notes: Class II device without 510k

79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects
Date Published: 03/20/2017

Desc: TiLENE Strip (surgical mesh)
Notes: Class II device without 510k

PHARMACT GMBH
Date Published : 04/15/2021
Universitatsmedizin Haus 41 , Theodor-Kutzer-Ufer 1-3 , Mannheim, Baden-Wurttemberg GERMANY
75 J - - KD Radioimmunoassay, C-Peptides Of Proinsulin
Date Published: 04/15/2021

Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test

83 O - - TG Non-sars coronavirus multiplex nucleic acid assay
Date Published: 04/15/2021

Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 04/15/2021

Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 04/15/2021

Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test

Pero-System Mebgerate Gmbh
Date Published : 05/17/2016
Lise-Meitner-Str. 1-9 , Wuppertal, North Rhine-Westphalia GERMANY
87 K - - TZ Caliper
Date Published: 05/17/2016

Desc: Perometer

89 L - - DK Device, Sensing, Optical Contour
Date Published: 05/17/2016

Desc: Perometer

Petra-Electricpeter Hohlfeldt Gmbh
Date Published : 09/16/2009
Greisbacherstrasse 6 , Burgau, GERMANY
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. Manufacturers for Anti-Aging Solutions. Revitalite Beautfying Soft Light Laser.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Pierenkemper Gmbh
Date Published : 06/04/2019
Wetzlarer Str. 41-43 , Ehringhausen, Hessen GERMANY
75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use
Date Published: 06/04/2019

Desc: Flexpulse

89 I - - SA Massager, Therapeutic, Electric
Date Published: 06/04/2019

Desc: Flexpulse

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 06/04/2019

Desc: Flexpulse

Purebeau New Cosmetics Gmbh
Date Published : 11/01/2017
Mozartstr. 12 , Berlin, Berlin GERMANY
50 N - - 99 Colors For Cosmetic Use (Not Certified), N.E.C.
Date Published: 11/01/2017

Desc: Fibroplast Pen 3.5 Thunder w/ Needles
Notes: Class II                                 

53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 11/01/2017

Desc: Fibroplast Pen 3.5 Thunder w/ Needles
Notes: Class II                                 

53 Y - - 04 Tattoo Ink
Date Published: 11/01/2017

Desc: Fibroplast Pen 3.5 Thunder w/ Needles
Notes: Class II                                 

79 O - - AB System ablations, low energy direct current and accessories
Date Published: 11/01/2017

Desc: Fibroplast Pen 3.5 Thunder w/ Needles
Notes: Class II                                 

QIAGEN LAKE CONSTANCE GMBH
Date Published : 07/27/2021
Bodenseeallee 20 , Stockach, GERMANY
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: ENTV-Dx LFR reader

Rayonex Biomedical Gmbh
Date Published : 07/13/2016
Sauerland-Pyramiden 1 , Lennestadt, North Rhine-Westphalia GERMANY
68 Y - - 20 Animal Drugs N.E.C. Used More Than 1 Species
Date Published: 07/13/2016

Desc: RAYOCOMP PS 10

84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief)
Date Published: 07/13/2016

Desc: Fabric Detector

84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief)
Date Published: 07/13/2016

Desc: RAYOCOMP PS 10

Reimers & Janssen Gmbh
Date Published : 10/11/2013
Reichenbergerstrasse 147 , Berlin, Berlin GERMANY
68 Z - - 99 Animal Medical Devices, NEC
Date Published: 03/12/2024

Desc: Infrared/Laser 70MW/785NM Laser Pen Devices
Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.

79 G - - EX Powered laser surgical instruments
Date Published: 03/12/2024

Desc: Infrared/Laser 70MW/785NM Laser Pen Devices
Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 10/11/2013

Desc: Infrared/Laser 70MW/785NM laser Pen Devices
Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.

95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 10/11/2013

Desc: Infrared/Laser 70MW/785NM laser Pen Devices
Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.

Reimers & Janssen Gmbh
Date Published : 08/30/2013
Fabrikstr. 22 , Waldkirch, Baden-wurttemberg GERMANY
68 Z - - 99 Animal Medical Devices, NEC
Date Published: 03/12/2024

Desc: Infrared/Laser 70MW/785NM Laser Pen Devices
Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.

79 G - - EX Powered laser surgical instruments
Date Published: 03/12/2024

Desc: Infrared/Laser 70MW/785NM Laser Pen Devices
Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 08/30/2013

Desc: Infrared/Laser 70MW/785NM laser Pen Devices
Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.

95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 10/11/2013

Desc: Infrared/Laser 70MW/785NM laser Pen Devices
Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.

Rheinmagnet Inc
Date Published : 09/16/2009
unknown , unknown, GERMANY
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: Magnetic Devices No classification name, number or regulation citation. 2/29/1996

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

ScheBo Tech Gmbh
Date Published : 03/02/2021
BahnhofstraBe 6 , Wettenberg, GERMANY
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/02/2021

Desc: SARS-CoV-2 Quick

Schebo-Tech Gmbh
Date Published : 03/02/2021
Netanyastr. 3 , Giesen, Hesse GERMANY
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/02/2021

Desc: SARS-CoV-2 Quick

Senova Gmbh
Date Published : 01/26/2021
Winzerlaer Str 2a , Jena, GERMANY
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: Bloom COVID-19 Test

Team Ver Packung
Date Published : 09/16/2009
Muhlen Koppel 2 , Ascheberg Trentrade, GERMANY
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: Silicone Oil for Opthalmic Use (Sterile)

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Tecsana Gmbh
Date Published : 09/16/2009
Planegger Str 9a , Muenchen, GERMANY
85 N - - TS Dilator, Cervical, Balloon
Date Published: 09/16/2009

Notes: 9/13/2006 Epi-No Delphine Trainer Plus

Vamedis Medical Products Gmbh
Date Published : 09/16/2009
Landwehrstrasse 70A , Munchen, GERMANY
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 01/30/2019

Desc: Synvisc Hylan Syringe Kits
Notes: (Product has European label which contains indications for use not yet approved in the United States); Class III; 6/20/2006

WELLCOMET GMBH
Date Published : 06/07/2023
Greschbachstr. 2-4 , Karlsruhe, Baden-Wurttemberg GERMANY
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 06/07/2023

Desc: Skinova Ultrasound Device
Notes: Class II device; requires 510(k); or de novo application

79 N - - RJ Ultrasound, Skin Permeation
Date Published: 06/07/2023

Desc: Skinova Ultrasound Device
Notes: Class II device; requires 510(k); or de novo application

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 06/07/2023

Desc: Skinova Ultrasound Device
Notes: Class II device; requires 510(k); or de novo application

WELLCOMET GMBH
Date Published : 06/07/2023
Am Mantel 4a , Bruchsal, Baden-Wurttemberg GERMANY
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 06/07/2023

Desc: Skinova Ultrasound Device
Notes: Class II device; requires 510(k); or de novo application

79 N - - RJ Ultrasound, Skin Permeation
Date Published: 06/07/2023

Desc: Skinova Ultrasound Device
Notes: Class II device; requires 510(k); or de novo application

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 06/07/2023

Desc: Skinova Ultrasound Device
Notes: Class II device; requires 510(k); or de novo application

Wildcat Deutchland Gmbh
Date Published : 01/13/2011
Wankelstrasse 5 , Gronau, GERMANY
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 01/13/2011

Desc: Terror Eyes Fashion Lenses
Notes: Class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 01/13/2011

Desc: Terror Eyes Fashion Lenses
Notes: Class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 01/13/2011

Desc: Terror Eyes Fashion Lenses
Notes: Class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 01/13/2011

Desc: Terror Eyes Fashion Lenses
Notes: Class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 01/13/2011

Desc: Terror Eyes Fashion Lenses
Notes: Class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 01/13/2011

Desc: Terror Eyes Fashion Lenses
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 01/13/2011

Desc: Terror Eyes Fashion Lenses
Notes: Class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 01/13/2011

Desc: Terror Eyes Fashion Lenses
Notes: Class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 01/13/2011

Desc: Terror Eyes Fashion Lenses
Notes: Class II

Wildcat Deutschland Gmbh
Date Published : 01/23/2019
Limbecker Str. 6 , Essen, GERMANY
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 01/23/2019

Desc: Fashion Contact Lenses "Terror Eyes"
Notes: Class II; 9/25/2009


GREECE


BioElectroDynamics
Date Published : 12/20/2018
no known street address , Athens, GREECE
84 - - - -- Neurological
Date Published: 12/20/2018

Desc: PAP-IMI Ion Magnetic Conductor Device
Notes: Unclassified


HONG KONG SAR


A & A Worldwide C/O Jp
Date Published : 11/28/2011
Room E 11/F West, Aidi Buildingbinhe , Hong Konghong Kong, HONG KONG SAR
79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Portable High Frequency Spot Remover; JX-006A Massager
Notes: Class II/III

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/28/2011

Desc: Portable High Frequency Spot Remover; JX-006A Massager
Notes: Class II/III

89 L - - YG Massager, Therapeutic, Manual
Date Published: 11/28/2011

Desc: Portable High Frequency Spot Remover; JX-006A Massager
Notes: Class II/III

A&A Worldwide Hong Kong Ltd
Date Published : 08/19/2012
Flat 6, G/F , Topsail Plaza 11; On Sum Street Siu Lek Yuen Shatin , Fotan, Shatin, HONG KONG SAR
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 08/19/2012

Desc: GS8.0 Cavitation Machine
Notes: class II

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 08/19/2012

Desc: GRF-11 Monopolor Radio Frequency Machine
Notes: class II

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 08/19/2012

Desc: GS8.0 Cavitation Machine
Notes: Class II

89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 08/19/2012

Desc: GRF-11 Monopolor Radio Frequency Machine
Notes: Class II

Ace Tec Hk Co Limited
Date Published : 08/01/2011
582-592 Nathan Road , Kowloon, HONG KONG SAR
89 - - - -- Physical Medicine
Date Published: 08/01/2011

Desc: SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound
Notes: Class II

Aosom E-Commerce Inc
Date Published : 03/25/2016
Room 1-1,1-2,No 22 Dajiaochang Road,Zhaobaoshan Street, Zhenhai , Ningbo, Zhejiang HONG KONG SAR
80 F - - LE Sterilizer, Steam
Date Published: 03/25/2016

Desc: Soozier 2in1 Personal Facial & Hair Steamer
Notes: Unknown Device Classification. Product labeling appear to indicate the device both treats and prevents diseases or conditions including dandruff; "treat the scalp", and skin pigmentation disorders. It also indicates to affect the structure and function of the body of man. Specifically the sponsor describes the device to speed nutrient absorption; sterilize and whiten skin; improve blood circulation and metabolism.

Asia Pacific Beauty Group Ltd
Date Published : 03/16/2012
15/F , Carnarvon Plaza; 20 Carnarvon Road , Tsim Sha Tsui, Kowloon HONG KONG SAR
79 G - - EX Powered laser surgical instruments
Date Published: 04/23/2012

Desc: Bio Hydroderm Hydrodermabrasion System
Notes: Class II

79 G - - EX Powered laser surgical instruments
Date Published: 03/16/2012

Desc: Bio-Synthesis Light activated facial rejuvenation system
Notes: Class II

79 G - - FD Dermatome
Date Published: 04/04/2012

Desc: Bio-Hydroderm V2 Microderm Abrasion units
Notes: Class II

79 G - - FD Dermatome
Date Published: 04/23/2012

Desc: Bio Hydroderm Hydrodermabrasion System
Notes: Class II

79 G - - FD Dermatome
Date Published: 03/16/2012

Desc: Bio-Synthesis Light activated facial rejuvenation system
Notes: Class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 08/21/2012

Desc: Bt-Micro Dermabrasion Unit
Notes: class II

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 08/21/2012

Desc: Bt-Micro Dermabrasion Unit
Notes: class II

Asia Unlimited
Date Published : 09/16/2009
Unknown , Hong Kong, HONG KONG SAR
86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 09/16/2009

Notes: The Shealy RelaxMate (aka RelaxEase) 8/27/1998

Aspiration Intl
Date Published : 10/29/2010
Unit 206 Blk B Hi Tech Ind Ctr491-501 , Tsuen Wantsuen Wan, HONG KONG SAR
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/29/2010

Desc: Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/29/2010

Desc: Contact Lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/29/2010

Desc: Contact Lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/29/2010

Desc: Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/29/2010

Desc: Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/29/2010

Desc: Contact Lenses
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/29/2010

Desc: Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/29/2010

Desc: Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/29/2010

Desc: Contact Lenses
Notes: class II

Aspiration Intl
Date Published : 10/29/2010
Unit 2706 , Mega Trade Centre; 1 Mei Wan St. , Tsuen Wan, New Territories HONG KONG SAR
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/29/2010

Desc: Contact lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/29/2010

Desc: Contact lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/29/2010

Desc: Contact lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/29/2010

Desc: Contact lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/29/2010

Desc: Contact lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/29/2010

Desc: Contact lenses
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/29/2010

Desc: Contact lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/29/2010

Desc: Contact lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/29/2010

Desc: Contact lenses
Notes: class II

Automatic Mfg. Ltd.
Date Published : 09/16/2009
5/F. , 227 Wai Yip Street , Kwun Tong, Kowloon HONG KONG SAR
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE. Shealy Relaxmate Glasses. 5/6/1994.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Azad International (HK) Ltd
Date Published : 09/16/2009
Trw 1 Room 2103 , 33 Canton Road , Tsim Sha Tsui, Kowloon HONG KONG SAR
76 M - - GE Hearing-Aid, Audiodontic
Date Published: 09/16/2009

Notes: WhisperXL mini-sound amplifier (behind the ear hearing aid) 12/21/1994

77 J - - YG Curette, Ear
Date Published: 02/10/2017

Desc: Smart Swab
Notes:                                                                                                              Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k).

77 J - - YT Pick, Microsurgical Ear
Date Published: 02/10/2017

Desc: Smart Swab
Notes:                                                                                                              Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k).

Bleosense Technology Co Ltd
Date Published : 05/29/2015
33 Mong Kok Road , Kowloon, HONG KONG SAR
89 I - - SA Massager, Therapeutic, Electric
Date Published: 05/29/2015

Desc: Finger Rollers
Notes: Class I

Century International
Date Published : 09/16/2009
5825 Nathan Road , Flat/Rm 701 Sino Ctr 582-592 , Mongkok, HONG KONG SAR
89 I - - OB Lamp, Infrared, Physical Medicine
Date Published: 01/23/2019

Desc: Hothouse FIR Health Builder
Notes: Reason; Lacks 510(k); 11/26/2001

Create Eyewear
Date Published : 12/06/2010
Unit 206, Block B491-501 Castle Peak , Tsuen Wantsuen Wan, HONG KONG SAR
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 12/06/2010

Desc: Contact Lenses (circle lenses)
Notes: Class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 12/06/2010

Desc: Contact Lenses (circle lenses)
Notes: Class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 12/06/2010

Desc: Contact Lenses (circle lenses)
Notes: Class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 12/06/2010

Desc: Contact Lenses (circle lenses)
Notes: Class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 12/06/2010

Desc: Contact Lenses (circle lenses)
Notes: Class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 12/06/2010

Desc: Contact Lenses (circle lenses)
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 12/06/2010

Desc: Contact Lenses (circle lenses)
Notes: Class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 12/06/2010

Desc: Contact Lenses (circle lenses)
Notes: Class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 12/06/2010

Desc: Contact Lenses (circle lenses)
Notes: Class II

E Concept Technology Co Ltd
Date Published : 05/11/2015
Floor 33 , Laws Commercial Plaza , Cheung Sha Wan, Kowloon HONG KONG SAR
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/11/2015

Desc: Portable High Frequency LZ-006A

E-Y Laboratories, (H.K.) Ltd.
Date Published : 09/16/2009
1 F Mei Wan Street , Tsuen Wan, New Territories HONG KONG SAR
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: HIVSCAN 1 2 Kit (Human Immunodeficiency Virus HIV-1 & HIV02 Test Kit) 10/28/2005. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIVSCAN 1 2 Kit (Human Immunodeficiency Virus HIV-1 & HIV02 Test Kit) 10/28/2005. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

ENANO HEALTH LTD
Date Published : 05/31/2022
Unit 623 Biotech Ctr 2 , Pak Shek Kok Nt, HONG KONG SAR
75 L - - FR Glucose Dehydrogenase, Glucose
Date Published: 05/31/2022

Desc: Saliva Glucose Tracker

75 N - - BW System, Test, Blood Glucose, Over the Counter
Date Published: 05/31/2022

Desc: Saliva Glucose Tracker

75 Q - - CD Continuous glucose monitor, implanted, adjunctive use
Date Published: 05/31/2022

Desc: Saliva Glucose Tracker

88 P - - PM General purpose reagent
Date Published: 05/31/2022

Desc: Saliva Glucose Tracker

Foshan Nanhai Newface Beauty Instruments
Date Published : 01/09/2013
G/F , Fat Lee Ind Bldg; Tai Road , Kowloon Bay, Kwun Tong HONG KONG SAR
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 01/09/2013

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 G - - FE Brush, Dermabrasion
Date Published: 01/23/2019

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 01/23/2019

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

Foshan Nanhai Xin Cheng Hardware
Date Published : 04/05/2013
Sin Fat Rd , Kwun Tong, Kowloon HONG KONG SAR
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 04/05/2013

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 G - - FE Brush, Dermabrasion
Date Published: 04/05/2013

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 01/23/2019

Desc: Facial Beauty Machine
Notes: Class II, DWPE Date 4/5/2013

GENELOGIC RESEARCH LIMITED
Date Published : 05/14/2021
Unit 349, 3f, Building , Shatin, HONG KONG SAR
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: Genelogic COVID-19 IgM/IgG Antibody Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: SARS-CoV-2 IgM/IgG Antibody Lateral Flow Assay

GREEN ISLAND INTERNATIONAL LTD
Date Published : 01/24/2018
3 Hau Fook Street , Tsim Sha Tsui, Kowloon HONG KONG SAR
84 M - - VV Device, Acupressure
Date Published: 01/24/2018

Desc: Silicon Cupping Sets

89 L - - YG Massager, Therapeutic, Manual
Date Published: 01/24/2018

Desc: Silicon Cupping Sets

GREEN ISLAND INTERNATIONAL TCM GROUP LIMITED
Date Published : 01/22/2018
7/F , Kiu Kin Mansion; 566-568 Nathan Road , Yau Ma Tei, Kowloon HONG KONG SAR
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 01/22/2018

Genesprint Group Limited
Date Published : 10/21/2020
20/f, Flat 2 , Flat 2, Malaysia Building; 50 Gloucester Road , Wan Chai, Hong Kong Island HONG KONG SAR
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/21/2020

Desc: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/21/2020

Desc: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/21/2020

Desc: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/21/2020

Desc: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)

Golden Wide Holdings Limited
Date Published : 07/13/2012
Flat/Rm 16a 7/F Well Fund Ind Ctr68ta , Tsim Sha Tsuitsim Sha Tsui, HONG KONG SAR
73 - - - -- Anesthesiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

74 - - - -- Cardiovascular
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

76 - - - -- Dental
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

77 - - - -- Ear,Nose And Throat
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

78 - - - -- Gastroenterological & Urological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

79 - - - -- General & Plastic Surgery
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

80 - - - -- General Hospital/Personal Use
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

84 - - - -- Neurological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

85 - - - -- Obstetrical & Gynecological
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

86 - - - -- Ophthalmic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

87 - - - -- Orthopedic
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

89 - - - -- Physical Medicine
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

90 - - - -- Radiology
Date Published: 07/13/2012

Notes: All Devices products; Class I, II, III

H-GUARD (CHINA) CO LTD
Date Published : 07/17/2020
7a The , 76a Fa Yuen Street , Mong Kok, Kowloon HONG KONG SAR
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)

Homesquare International Ltd
Date Published : 01/30/2019
Ever Gain Plaza Tower 2 , 88 Container Port Road , Kwai Chung, New Territories HONG KONG SAR
89 G - - ZC Stimulator, Neuromuscular, Implanted
Date Published: 01/30/2019

Desc: ABGYMNIC Electronic Gymnastic Device
Notes: 6/27/2002

89 I - - PF Stimulator, Muscle, Powered
Date Published: 01/30/2019

Desc: ABGYMNIC Electronic Gymnastic Device
Notes: 6/27/2002

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/30/2019

Desc: ABGYMNIC Electronic Gymnastic Device
Notes: 6/27/2002

89 L - - YG Massager, Therapeutic, Manual
Date Published: 01/30/2019

Desc: ABGYMNIC Electronic Gymnastic Device
Notes: 6/27/2002

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 01/30/2019

Desc: ABGYMNIC Electronic Gymnastic Device
Notes: 6/27/2002

INTCO MEDICAL INTERNATIONAL (HONG KONG) CO LTD
Date Published : 02/27/2024
Suite 1606,16th Floor,The Gateway , Harbour City, HONG KONG SAR
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 02/27/2024

Desc: OMAR Powder-Free Nitrile Examination Gloves White

80 O - - IG Rubber examination gloves, powder-free
Date Published: 02/27/2024

Desc: OMAR Powder-Free Nitrile Examination Gloves White

Mayu Technology Group Co., Ltd.
Date Published : 11/13/2012
Unit 2401a , 24/F., Park-in Comm. Ctr. , Mong Kok, Kowloon HONG KONG SAR
89 I - - LJ Bath, Hydro-Massage
Date Published: 11/13/2012

Desc: Ion Cleanse Massager
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/13/2012

Desc: Ion Cleanse Massager
Notes: Class II

Nh Limited Narl Exclusive
Date Published : 11/15/2010
2f 30 Haiphong Rd , Kowloon, HONG KONG SAR
79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 11/15/2010

Desc: NARL 517 MS (Beauty Equipment Massager)
Notes: Class III

89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 11/15/2010

Desc: NARL 517 MS (Beauty Equipment Massager)
Notes: Class III

PRENETICS LIMITED
Date Published : 11/15/2021
701-706,K11 Atelier King's Road , 728 King's Road , Quarry Bay, HONG KONG SAR
83 Q - - LW COVID-19 test home collection kit devices
Date Published: 11/15/2021

Desc: Circle HealthPod Rapid Detention System for Covid 19

Promis Asla Hk
Date Published : 07/20/2012
Shop 62a Nd Floor Mirrador Mansion , Kowloon, HONG KONG SAR
73 - - - -- Anesthesiology
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

74 - - - -- Cardiovascular
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

76 - - - -- Dental
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

77 - - - -- Ear,Nose And Throat
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

78 - - - -- Gastroenterological & Urological
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

79 - - - -- General & Plastic Surgery
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

80 - - - -- General Hospital/Personal Use
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

84 - - - -- Neurological
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

85 - - - -- Obstetrical & Gynecological
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

86 - - - -- Ophthalmic
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

87 - - - -- Orthopedic
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

89 - - - -- Physical Medicine
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

90 - - - -- Radiology
Date Published: 07/20/2012

Notes: All device products; Class I/II/III

RUNZHAN TECHNOLOGY LIMITED
Date Published : 04/18/2017
Room 1612, 16/F , Taiyau; 181 Johnston Road , Wanchai, HONG KONG SAR
79 M - - WZ Expander, Breast, External
Date Published: 04/18/2017

Desc: Breast Massager

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 04/18/2017

Desc: Breast Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/18/2017

Desc: Breast Massager

SURE BIO-TECH (HONG KONG) CO LIMITED
Date Published : 07/07/2020
15/F, Room 1502 , Easey Commercial Building; 253-261 Hennessy Road , Wan Chai, Hong Kong Island HONG KONG SAR
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/07/2020

Desc: API Covid-Rapid IgM/IgG Antibody Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/07/2020

Desc: API Covid-Rapid IgM/IgG Antibody Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/07/2020

Desc: API Covid-Rapid IgM/IgG Antibody Test Kit

Soft Lines
Date Published : 09/16/2009
1 Science Museum Road , Tsim Sha Tsui, Kowloon HONG KONG SAR
78 M - - NW Analyzer, Body Composition
Date Published: 11/08/2018

Notes: Emjoi Body Fat Monitor AP-30 (Body Composition Analyzer) 8/26/2003. Lack of 510(k) Approval.

Sundries Network International Ltd.
Date Published : 09/16/2009
300-306 Lockhart Road , Flat B, 4/F, Kiu Fu Comm. Building , Chai Wan, HONG KONG SAR
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: OC's HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: OC's HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis- diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Technic Star Universal
Date Published : 01/23/2019
Limited Room 1013 Hung To Road , Road No. 1 Kwun Tong , Kowloon, HONG KONG SAR
76 K - - KO Ring, Teething, Fluid-Filled
Date Published: 01/23/2019

Desc: Shaker Teether Toy
Notes: Class II; 10/5/2009

76 K - - KO Ring, Teething, Fluid-Filled
Date Published: 01/23/2019

Desc: Gel Filled Infant Teether
Notes: Class II; 10/5/2009

Tega Industrial Company Ltd.
Date Published : 10/20/2010
Room 1202 Tower 2 Harbour Centre8 Hok , Hong Kong, HONG KONG SAR
80 M - - IO Light, Therapy, Sad(Seasonal Affective Disorder)
Date Published: 10/20/2010

Desc: Day Light Bright Light Therapy Systems
Notes: Class II

Vicky Logistics Ltd
Date Published : 08/07/2012
2 Xing Wei Rd , Fuyong, HONG KONG SAR
89 I - - SA Massager, Therapeutic, Electric
Date Published: 08/21/2012

Desc: Muscle Stimulator
Notes: Class II

89 N - - YZ Stimulator, muscle, powered, with limited output, for muscle conditioning
Date Published: 08/07/2012

Desc: Muscle Stimulator
Notes: CLASS -- II

West Tech Ltd
Date Published : 12/11/2013
132 Nathan Rd , Kolwoon, HONG KONG SAR
80 M - - QX Needle, Acupuncture, Single Use
Date Published: 12/11/2013

Desc: Micro Needle Skin Roller
Notes: class II

Zero Plus International Limited
Date Published : 07/11/2011
10/F, 1004/Room , Join In Hang Sing Centre; 71 Container Port Road , Kwai Chung, New Territories HONG KONG SAR
79 G - - EX Powered laser surgical instruments
Date Published: 07/11/2011

Desc: SL-50 Cluster Laser
Notes: Class II

79 O - - NF Powered light based non-laser surgical instrument with thermal effect
Date Published: 07/11/2011

Desc: SL-50 Cluster Laser
Notes: Class II

89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy
Date Published: 07/11/2011

Desc: SL-50 Cluster Laser
Notes: Class II


HUNGARY


Erxer Bt.
Date Published : 09/16/2009
Napsugar U. 21 , Csomad, HUNGARY
89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Date Published: 09/16/2009

Notes: Pollogen Regan/Pollegen MJ 5/12/2009 Shipper for Pollegen Ltd.

MANDELAY KFT
Date Published : 01/23/2019
Huba Utca 25-2 , Tokol, Pest HUNGARY
84 H - - CC Device, Biofeedback
Date Published: 05/06/2021

Notes: Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/2008.

84 - - - -- Neurological
Date Published: 01/23/2019

Desc: The Quantum Xrroid Consciousness/Medical Interface System Unclassified
Notes: 6/28/2002

QX World Kft.
Date Published : 01/30/2020
Tinodi Utca 1-3/A. Ep. Iv. Em. 93 , Budapest Ix, Budapest HUNGARY
84 H - - CC Device, Biofeedback
Date Published: 01/30/2020

Desc: Educator Biofeedback Device


INDIA


ACHIRA LAB PVT LTD
Date Published : 11/24/2021
66b 13th Cross Rd Dolla , Jp Bengaluru Karnatak, INDIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: GenePath CoViSwift v3.0

Accord Medical Pro
Date Published : 10/26/2018
315 Rg Complex 1 , New Delhi, INDIA
73 - - - -- Anesthesiology
Date Published: 10/26/2018

Notes: All Devices

74 - - - -- Cardiovascular
Date Published: 10/26/2018

Notes: All Devices

76 - - - -- Dental
Date Published: 10/26/2018

Notes: All Devices

77 - - - -- Ear,Nose And Throat
Date Published: 10/26/2018

Notes: All Devices

78 - - - -- Gastroenterological & Urological
Date Published: 10/26/2018

Notes: All Devices

79 - - - -- General & Plastic Surgery
Date Published: 10/26/2018

Notes: All Devices

80 - - - -- General Hospital/Personal Use
Date Published: 10/26/2018

Notes: All Devices

84 - - - -- Neurological
Date Published: 10/26/2018

Notes: All Devices

85 - - - -- Obstetrical & Gynecological
Date Published: 10/26/2018

Notes: All Devices

86 - - - -- Ophthalmic
Date Published: 10/26/2018

Notes: All Devices

87 - - - -- Orthopedic
Date Published: 10/26/2018

Notes: All Devices

89 - - - -- Physical Medicine
Date Published: 10/26/2018

Notes: All Devices

90 - - - -- Radiology
Date Published: 10/26/2018

Notes: All Devices

Accord Medical Products Pvt. Ltd.
Date Published : 10/26/2018
C9/74 , Delhi, Delhi INDIA
73 - - - -- Anesthesiology
Date Published: 10/26/2018

Notes: All Devices

74 - - - -- Cardiovascular
Date Published: 10/26/2018

Notes: All Devices

76 - - - -- Dental
Date Published: 10/26/2018

Notes: All Devices

77 - - - -- Ear,Nose And Throat
Date Published: 10/26/2018

Notes: All Devices

78 - - - -- Gastroenterological & Urological
Date Published: 10/26/2018

Notes: All Devices

79 - - - -- General & Plastic Surgery
Date Published: 10/26/2018

Notes: All Devices

80 - - - -- General Hospital/Personal Use
Date Published: 10/26/2018

Notes: All Devices

84 - - - -- Neurological
Date Published: 10/26/2018

Notes: All Devices

85 - - - -- Obstetrical & Gynecological
Date Published: 10/26/2018

Notes: All Devices

86 - - - -- Ophthalmic
Date Published: 10/26/2018

Notes: All Devices

87 - - - -- Orthopedic
Date Published: 10/26/2018

Notes: All Devices

89 - - - -- Physical Medicine
Date Published: 10/26/2018

Notes: All Devices

90 - - - -- Radiology
Date Published: 10/26/2018

Notes: All Devices

Aegis Lifesciences
Date Published : 03/10/2014
215/216 Mahagujrat Industrial , Moraiy , Changodar, Gujarat INDIA
79 L - - MF Agent, Absorbable Hemostatic, Collagen Based
Date Published: 03/10/2014

Desc: Agent Aborbable Hemostatic Collagen Blend
Notes: Class III

Ai Optics Limited
Date Published : 05/16/2011
20 Sbi Officers Colony, 1st St , Arumbakkam, INDIA
86 H - - QL Lens, Intraocular
Date Published: 05/16/2011

Desc: Intraocular Lens Guides; Intraocular Lenses
Notes: Class III

86 M - - SS Folders and Injectors, Intraocular Lens (IOL)
Date Published: 05/16/2011

Desc: Intraocular Lens Guides; Intraocular Lenses
Notes: Class III

Appasamy Associates
Date Published : 09/16/2009
11a , Valluvar Nedum Pathai , Rani Anna Nagar , Arumbakkam, Tamil Nagar INDIA
86 H - - QL Lens, Intraocular
Date Published: 05/16/2011

Desc: Intraocular Lens Guides; Intraocular Lenses
Notes: Class III

86 H - - QL Lens, Intraocular
Date Published: 09/16/2009

Notes: Intraocular Lens

86 M - - SS Folders and Injectors, Intraocular Lens (IOL)
Date Published: 05/16/2011

Desc: Intraocular Lens Guides; Intraocular Lenses
Notes: Class III

Appasamy Ocular Devices Pvt. Limited
Date Published : 09/16/2009
Nh 45-A, Vadamangalam Village , Villupuram Main Road , Kandamangalam, Tamil Nadu INDIA
86 L - - ZP Aid, Surgical, Viscoelastic
Date Published: 09/16/2009

Notes: Appavisv PFS Hydroxypropyl Methyl Cellulose Opthalmic Solution USP 2% Labeled for Intracular Use 6/19/2006

BIOGENEX LIFE SCIENCES PVT. LTD.
Date Published : 01/21/2022
SURVEY NO. 225 & 226 , INDUSTRIAL DEVELOPMENT AREA - PHASE II , HYDERABAD, INDIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/13/2022

Desc: BGX COVID-19 RT-PCR

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/21/2022

Desc: COVID-19 RT-PCR Direct; Nasal Swab Home Collection Kit

BIOGENEX LIFE SCIENCES PVT. LTD.
Date Published : 01/21/2022
Plot No.4, Survey #656/A , Hyderabad, INDIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/21/2022

Desc: COVID-19 RT-PCR Direct; Nasal Swab Home Collection Kit

Dent Eq
Date Published : 01/22/2020
101-1 Surveyor St , Bangalore, INDIA
75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use
Date Published: 01/22/2020

Desc: Sterilizer Glass Bead

76 E - - CC Sterilizer, Glass Bead
Date Published: 01/22/2020

Desc: Sterilizer Glass Bead

80 F - - LE Sterilizer, Steam
Date Published: 01/22/2020

Desc: Sterilizer Glass Bead

GENEPATH DIAGNOSTICS INDIA PRIVATE
Date Published : 11/24/2021
Above Phadkehospital , 4th Floor; Jangli Maharaj Road , Pune, Maharashtra INDIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: GenePath CoViSwift v3.0

HEALTH CARE LATEX LTD.
Date Published : 09/16/2009
A-33/A SECTOR-8 , Noida (U.P.), INDIA
78 H - - IR Perineometer
Date Published: 11/08/2018

Notes: Latex Condoms 7/6/1992

85 H - - IS Condom
Date Published: 01/23/2019

Desc: Latex Condoms
Notes: 5/16/2005

85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009

Notes: Latex Condoms 7/6/1992

85 M - - OL Condom, Non-Latex
Date Published: 09/16/2009

Notes: Latex Condoms 7/6/1992

International Medical Devices
Date Published : 09/16/2009
17 Industrial Estate , Gurgaon, Haryana INDIA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices GPI = DE. Freeman Universal Intraocular Lenses (IOL) Anterior Chamber Optional Posterior Chamber. Style Code IMD-AC-FA. 7/6/1992.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

LAB-CARE DIAGNOSTICS (INDIA) PVT
Date Published : 03/11/2021
C1 Type Shed No 3225 Ch , Gujarat, INDIA
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: ACCUCARE COVID-19 IgG/IgM Lateral Flow Assay Test Kit

M/S Suruchi International
Date Published : 09/16/2009
207 Sector 7a Fardabad 121001 , Haryana, INDIA
85 H - - IS Condom
Date Published: 09/16/2009

Notes: Condoms 3/15/2005

85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009

Notes: Condoms 3/15/2005

85 M - - OL Condom, Non-Latex
Date Published: 09/16/2009

Notes: Condoms 3/15/2005

MOLBIO DIAGNOSTICS PRIVATE
Date Published : 10/28/2021
Plot No. L-46 Phase Ii , Mumbai, INDIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/28/2021

Desc: Truenat%u2122 SARS CoV-2

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/28/2021

Desc: Truenat%u2122 Beta CoV

MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
Date Published : 05/28/2021
Plot No. 99-B , Lonavla Industrial Co-Operative Estate Ltd, Nangargaon, Lonavla , Pune, Maharashtra INDIA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/28/2021

Desc: PathoCatch COVID-19 Antigen Lateral Flow Test Device

Sandhu Exports
Date Published : 09/16/2009
3, Sant Nagar East of Kailash , New Delhi, INDIA
85 H - - IS Condom
Date Published: 09/16/2009

Notes: Condoms 3/10/2005

85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009

Notes: Condoms 3/10/2005

85 M - - OL Condom, Non-Latex
Date Published: 09/16/2009

Notes: Condoms 3/10/2005

Sewa Medicals Ltd
Date Published : 06/06/2014
Gut No. 229-232, Alandi Markal Road , Village Markal Taluka Khed, Taluka:Khed , Pune, Maharashtra INDIA
80 F - - MF Syringe, Piston
Date Published: 06/06/2014

Desc: Medical Syringes
Notes: class II

80 K - - ZH Introducer, Syringe Needle
Date Published: 06/06/2014

Desc: Medical Syringes
Notes: class II

80 M - - EG Syringe, Antistick
Date Published: 06/06/2014

Desc: Medical Syringes
Notes: class II

Shah & Shah Intraocular Lens (Pvt) Ltd
Date Published : 09/16/2009
23 Russell Street , Next To 1 J M D H Road Joka 743 512 , Calcutta, INDIA
86 H - - QL Lens, Intraocular
Date Published: 09/16/2009

Notes: Intraocular Lenses 4/10/1995.


IRELAND


Hemcon Medical Technologies Europe, Ltd.
Date Published : 09/08/2015
Blackrocks , 515 Orwell Park Way , Dublin 6w, Co. DUBLIN IRELAND
77 L - - YA Splint, Intranasal Septal
Date Published: 09/08/2015

Desc: Splint; Intranasal Septal
Notes: Class I; Synaero

REALTIME TECHNOLOGIES LTD
Date Published : 10/23/2019
Realtime Building , Colonhaugh Business Pk , Dublin, IRELAND
74 D - - PS Electrocardiograph
Date Published: 10/23/2019

Desc: ECG/EMG Integretion Shimmer

84 I - - KN Electromyograph, Diagnostic
Date Published: 10/23/2019

Desc: ECG/EMG Integretion Shimmer

THE OCCLUSION CUFF LTD
Date Published : 07/13/2020
Comacrieve , Emyvale Co , Monaghan, IRELAND
79 K - - CY Tourniquet, Pneumatic
Date Published: 07/13/2020

Desc: Occlusion Cuff Pneumatic Tourniquet

87 L - - ZE Isometer
Date Published: 07/13/2020

Desc: Occlusion Cuff Pneumatic Tourniquet


ISRAEL


BIOVO TECHNOLOGIES
Date Published : 07/29/2013
5, Ha-Arad , ST. , Tel Aviv-Yafo, TEL-AVIV ISRAEL
73 B - - TR Tube, Tracheal (W/Wo Connector)
Date Published: 07/29/2013

Desc: Airway Medix Closed Suction Systems
Notes: Class II

Bd Sigma
Date Published : 08/02/2011
Yagur St 2 , Haifa, ISRAEL
89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 08/02/2011

Desc: Tripollar POSE; Tripollar STOP
Notes: Class II

Invasix Ltd.
Date Published : 04/19/2013
Tavor Building , Pob 533 , Yokneam, Ha Zafon ISRAEL
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 04/19/2013

Desc: Invasix BodyTite (aka Invasix RFAL
Notes: Class II

Medispec, Ltd.
Date Published : 05/17/2010
40, Hataasiya Street , Yehud, ISRAEL
89 O - - OV Evopace system and accessories
Date Published: 05/17/2010

Desc: Radialspec
Notes: Class III

Pollogen Ltd
Date Published : 09/16/2009
6 KAUFMAN STREET , TEL AVIV, ISRAEL
89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Date Published: 06/29/2018

Desc: Pollogen Apollo
Notes: Class III; 5/12/2009

89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Date Published: 09/16/2009

Notes: Pollogen Regan; 5/12/2009; Class III

Ultragen Ltd
Date Published : 08/02/2011
6 Kaufman Street , Gabor House, Po Box 50320 , Tel Aviv, ISRAEL
89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 08/02/2011

Desc: Tripollar POSE; Tripollar STOP
Notes: Class II

Zer Hitech
Date Published : 09/16/2009
3, Shatner , Center , Jerusalem, ISRAEL
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 01/30/2019

Notes: HIV I and II One Step Tests 7/9/1998. Several FDA districts have encountered shipments of unapproved test kits and labeled for "research use only" or "investigationa use only" and some of the kits were unlabeled. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. Investigation by FDA revealed that the unapprived HIV diagnostic test kits were intended for commercial distribution; and not for "research" or "investigation" uses as invoiced. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201

57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 01/30/2019

Desc: HIV-I II One-Step Test and Quick AIDS Test
Notes: 8/23/2001

82 - - - -- Immunology
Date Published: 01/30/2019

Desc: HIV-I II One-Step Test and Quick AIDS Test
Notes: 8/23/2001


ITALY


BRERA MEDICAL TECHNOLOGIES S.R.L.
Date Published : 09/29/2009
84061 Loc. Terzerie, Z.I. , Ogliastro C. To (Sa) , Ogliastro, ITALY
79 G - - FE Brush, Dermabrasion
Date Published: 09/29/2009

Desc: SkinBella Crystal-Free Microdermabrasion System
Notes: Class I; Firm has no 510K for the product

Biorem S.R.L.
Date Published : 09/16/2009
Via Francesco Angrisani 18A , Agropoli, Salerno ITALY
79 G - - EX Powered laser surgical instruments
Date Published: 09/16/2009

Notes: SkinMaster MicroDermabrasion Product 1/2/2002

79 G - - FD Dermatome
Date Published: 09/16/2009

Notes: SkinMaster MicroDermabrasion Product 1/2/2002

DIAGNOSTIC SRL
Date Published : 06/07/2018
Largo Ferrandina 10 , Naples, Naples ITALY
75 - - - -- Chemistry
Date Published: 06/07/2018

Notes: In vitro diagnostic products

81 - - - -- Hematology
Date Published: 06/07/2018

Notes: In vitro diagnostic products

82 - - - -- Immunology
Date Published: 06/07/2018

Notes: In vitro diagnostic products

83 - - - -- Microbiology
Date Published: 06/07/2018

Notes: In vitro diagnostic products

88 - - - -- Pathology
Date Published: 06/07/2018

Notes: In vitro diagnostic products

91 - - - -- Toxicology
Date Published: 06/07/2018

Notes: In vitro diagnostic products

92 - - - -- Molecular Genetics
Date Published: 06/07/2018

Notes: In vitro diagnostic products

De Sisti Lighing Srl
Date Published : 11/22/2011
Via Canncelliera 10/A , 00040 Albano Laziale , Rome, ITALY
84 N - - HH Device, Discharge, Electrostatic (for Pain Relief), Device, Discharge, Electrostatic (for Pain Relief)
Date Published: 11/22/2011

Desc: Physia Pain Relief Machine
Notes: class II

Di Blasi Industriale Srl
Date Published : 01/27/2023
Contrada Risicone , Vizzini, Catania ITALY
89 I - - NI Vehicle, Motorized 3-Wheeled
Date Published: 01/27/2023

Desc: Di Blasi R30; 3-wheeled Scooter

89 K - - NL Board, Scooter, Prone
Date Published: 01/27/2023

Desc: Di Blasi R30; 3-wheeled Scooter

ELETTRONICA PAGANI SRL
Date Published : 08/08/2022
Via Enrico De Nicola 4d , Paderno Dugnano, Milan ITALY
79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager
Date Published: 08/08/2022

Desc: HC Cryo T-Shock

79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager
Date Published: 08/08/2022

Desc: Cryoskin

FENIX GROUP S.R.L.
Date Published : 11/27/2023
Via Agostinone 9 , Montesilvano, Pescara ITALY
79 N - - UV Massager, Vaccuum, light induced heating
Date Published: 11/27/2023

Desc: Endospheres Device

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/27/2023

Desc: Endospheres Device

FENIX GROUP SRL
Date Published : 11/27/2023
Strada Lungofino 187 , Citta Sant Ange, ITALY
79 N - - UV Massager, Vaccuum, light induced heating
Date Published: 11/27/2023

Desc: Endospheres Device

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/27/2023

Desc: Endospheres Device

H&D Srl
Date Published : 10/23/2019
Strada Langhirano 264/1a , Parma, Parma ITALY
75 J - - JE Analyzer, Chemistry (Photometric, Discrete) For Clinical Use
Date Published: 10/23/2019

Desc: FRAS 5 (Free Radical Analytical System) Device & Sample Kit

83 O - - TT Research use only/microbiology
Date Published: 10/23/2019

Desc: FRAS 5 (Free Radical Analytical System) Device & Sample Kit

Hyris S.R.L.
Date Published : 11/24/2021
Corso Giuseppe Garibaldi 60 , Milan, Milan ITALY
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: bKIT Virus Finder COVID-19

Incosmo S.R.L
Date Published : 03/20/2018
Via I Maggio 7 , Biassono, Monza E della Brianza ITALY
80 K - - MJ Lubricant, Patient
Date Published: 03/20/2018

Desc: Long-Lasting Personal Lubricant

80 M - - MS Lubricant, Vaginal, Patient
Date Published: 03/20/2018

Desc: Long-Lasting Personal Lubricant

85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible
Date Published: 03/20/2018

Desc: Long-Lasting Personal Lubricant

Medico SPA
Date Published : 09/16/2009
Via Pitagora 15 , Rubano, Padova ITALY
74 D - - XY Pulse-Generator, Pacemaker, Implantable
Date Published: 09/16/2009

Notes: 12/08/1992 Pacemaker (Phymos ADV/VDD-M)

Micromed Srl
Date Published : 09/29/2009
V Oberdan 21 , Fonte Nuovafonte Nuova, ITALY
86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina
Date Published: 01/23/2019

Desc: Perfluorodecaline
Notes: Class III; 8/18/2009

86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina
Date Published: 01/23/2019

Desc: GasMate
Notes: Class III; 8/18/2009

86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina
Date Published: 01/23/2019

Desc: Intraocular Silicone Oil
Notes: Class III; 8/18/2009

86 L - - WL Fluid, Intraocular
Date Published: 01/23/2019

Desc: Perfluorodecaline
Notes: Class III; 8/18/2009

86 L - - WL Fluid, Intraocular
Date Published: 01/23/2019

Desc: Intraocular Silicone Oil
Notes: Class III; 8/18/2009

86 L - - WL Fluid, Intraocular
Date Published: 01/23/2019

Desc: GasMate
Notes: Class III; 8/18/2009

Micromed Srl
Date Published : 01/23/2019
Vle Valpadana 126 , Romaroma, ITALY
86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina
Date Published: 01/23/2019

Desc: Intraocular Silicone Oil
Notes: Class III; 8/18/2009

86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina
Date Published: 01/23/2019

Desc: GasMate
Notes: Class III; 8/18/2009

86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina
Date Published: 01/23/2019

Desc: Perfluorodecaline
Notes: Class III; 8/18/2009

86 L - - WL Fluid, Intraocular
Date Published: 01/23/2019

Desc: GasMate
Notes: Class III; 8/18/2009

86 L - - WL Fluid, Intraocular
Date Published: 01/23/2019

Desc: Perfluorodecaline
Notes: Class III; 8/18/2009

86 L - - WL Fluid, Intraocular
Date Published: 01/23/2019

Desc: Intraocular Silicone Oil
Notes: Class III; 8/18/2009

Quadra Medical SRL
Date Published : 11/21/2012
VIA NARDA 38, 98 Romano D'Ezzelino , VIA CARTIGLIANA 143B , Venice, IT-VI ITALY
73 - - - -- Anesthesiology
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

74 - - - -- Cardiovascular
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

76 - - - -- Dental
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

77 - - - -- Ear,Nose And Throat
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

78 - - - -- Gastroenterological & Urological
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

79 - - - -- General & Plastic Surgery
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

80 - - - -- General Hospital/Personal Use
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

84 - - - -- Neurological
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

85 - - - -- Obstetrical & Gynecological
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

86 - - - -- Ophthalmic
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

87 - - - -- Orthopedic
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

89 - - - -- Physical Medicine
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

90 - - - -- Radiology
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

Quadra Medical SRL
Date Published : 11/21/2012
VIA NARDA 38, 98 Romano D'Ezzelino , VIA CARTIGLIANA 143B , Venice, IT-VI ITALY
73 - - - -- Anesthesiology
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

74 - - - -- Cardiovascular
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

76 - - - -- Dental
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

77 - - - -- Ear,Nose And Throat
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

78 - - - -- Gastroenterological & Urological
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

79 - - - -- General & Plastic Surgery
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

80 - - - -- General Hospital/Personal Use
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

84 - - - -- Neurological
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

85 - - - -- Obstetrical & Gynecological
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

86 - - - -- Ophthalmic
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

87 - - - -- Orthopedic
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

89 - - - -- Physical Medicine
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

90 - - - -- Radiology
Date Published: 11/21/2012

Notes: All medical devices class I/II/III

Quattroti Dentech Srl
Date Published : 02/04/2010
Via Mestri Del Lavoro 120 , Cislago, Varese ITALY
76 M - - QC Mouthguard
Date Published: 02/04/2010

Desc: Dr Brux mouth guards night guards

76 O - - BR Mouthguard, over-the-counter
Date Published: 02/04/2010

Desc: Dr Brux mouth guards night guards

RIMOS SRL
Date Published : 09/16/2009
VIA MANUZIO 15 , Mirandola, Modena ITALY
80 F - - MI Needle, Hypodermic, Single Lumen
Date Published: 09/16/2009

Notes: Mesotherapy Needles and Hypodermic Needles 10/19/2005

80 K - - ZE Injector, Fluid, Non-Electrically Powered
Date Published: 09/16/2009

Notes: Mesotherapy Needles and Hypodermic Needles 10/19/2005

80 K - - ZH Introducer, Syringe Needle
Date Published: 09/16/2009

Notes: Mesotherapy Needles and Hypodermic Needles 10/19/2005

Sa Mas. S.r.l.
Date Published : 09/16/2009
31014 Colle Umberto (Tv) , Via Tarlazzi 5 , Umberto, Umberto ITALY
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 09/16/2009

Notes: Sttila Evoluzione Electrical Stimulation Device. 4/12/2001.

Sacace Biotechnologies
Date Published : 04/06/2017
Via Giovanni Battista Scalabrini 44 , Como, Como ITALY
57 V - - 10 Hepatitis C Virus Encoded Antigen
Date Published: 04/06/2017

Desc: HCV Real TM Quant
Notes: Class III device without a PMA approval

81 K - - SJ System For The Identification Of Hepatitis B Antigen
Date Published: 04/06/2017

Desc: HCV Real TM Quant
Notes: Class III device without a PMA approval

81 K - - SJ System For The Identification Of Hepatitis B Antigen
Date Published: 04/06/2017

Desc: HBV Real TM Quant
Notes: Class III device without a PMA approval

83 M - - KT Device, Detection, Hepatitus, Viral B DNA
Date Published: 04/06/2017

Desc: HBV Real TM Quant
Notes: Class III device without a PMA approval

83 M - - ZP Assay, Hybridization and/or Nucleic Acid Amplification For Detection of Hepatitis C RNA, Hepatitis C
Date Published: 04/06/2017

Desc: HCV Real TM Quant
Notes: Class III device without a PMA approval

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/29/2022

Desc: SARS-CoV-2 Real-TM

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/29/2022

Desc: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/29/2022

Desc: AccuraDTect SARS-CoV-2 RT-qPCR Kit

Sandona Snc
Date Published : 02/01/2017
Via Carlo Alberto 50 , Treviso, ITALY
80 H - - FS Shield, Nipple
Date Published: 02/01/2017

Desc: Sterling Silver Nipple Shield
Notes: Class I device without a valid 510k

Sentinel CH SpA
Date Published : 12/03/2021
Via Robert Koch 2 , Milan, Milan ITALY
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 12/03/2021

Desc: STAT-NAT COVID-19 MULTI

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 12/03/2021

Desc: STAT-NAT COVID-19 Positive Control

Smie Srl
Date Published : 09/16/2009
Via Francesco Negri 15 , Casale Monferrato, Alexandria ITALY
85 M - - GI Aspirator, Ultrasonic
Date Published: 09/16/2009

Notes: Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/1999

Vupiesse Italia Srl
Date Published : 01/22/2015
49 Via Della Lontra , Rimini, Rimini ITALY
84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 01/22/2015

Desc: TUA VISO Non Surgical Facelift
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/22/2015

Desc: TUA VISO Non Surgical Facelift
Notes: class II

Zeropiu' Srl
Date Published : 01/30/2019
Via Veneto 2 , Schioschio, ITALY
89 K - - NM Device, Pressure Applying
Date Published: 01/30/2019

Desc: Zerosmoke Biomagnets
Notes: 9/18/2009


JAPAN


Cosmo Sonic Inc
Date Published : 05/14/2014
1-17 4 Hongo , Bunkyo-Ku, Tokyo JAPAN
89 - - - -- Physical Medicine
Date Published: 05/14/2014

Desc: Devices
Notes: Class II

Daito Electric Machine Industries Company, Ltd.
Date Published : 09/16/2009
Higashiosaka-Osaka 9-11 , Showa-Cho , Osaka, Osaka JAPAN
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 09/16/2009

Notes: Massagers; Muscle Stimulators 4/29/2003

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Massagers; Muscle Stimulators 4/29/2003

89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/16/2009

Notes: Massagers; Muscle Stimulators 4/29/2003

89 M - - PH Stimulator, Electrical, Muscle
Date Published: 09/16/2009

Notes: Massagers; Muscle Stimulators 4/29/2003

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes: Massagers; Muscle Stimulators 4/29/2003

Fuji Latex Co., Ltd.
Date Published : 09/16/2009
150 Ko-Machi , Tokyo, JAPAN
85 H - - IS Condom
Date Published: 09/16/2009

Notes: Wrinkle Chapeau Condoms. 7/20/1993

Fuji Medical Insts. Mfg. Co., Ltd.
Date Published : 09/16/2009
5 Chome 5-21 , Nipponbashi; Naniwa , Osaka, Osaka JAPAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. DE. "New Health Club" Low Frequency Therapeutic Apparatus Type C Model HC-32. 8/13/1993

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Fujirebio Inc
Date Published : 07/27/2021
51 Komiya-Cho Hachioji-Shi , Tokyo, JAPAN
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: ASAPath COVID-19 Antigen Rapid Test (Kit Ref#10028505)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: Lumipulse G SARSCoV-2 Ag-Qual

Hirayama Manufacturing Corporation
Date Published : 09/16/2009
216-16 , Yushima , Bunkyo, Tokyo JAPAN
75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use
Date Published: 09/16/2009

Notes: Sterilizer; Autoclave 9/17/1998

Kyocera Corporation
Date Published : 09/16/2009
Gamo Block, 10-1 Kawai , Gamo-cho, Gamo-Gun , Shiga-Ken, JAPAN
87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
Date Published: 09/16/2009

Notes: Ceramic Aluminum and Zirconium Balls for Hip Implants 1/13/2005

Maramunji Sangyo Co LTD
Date Published : 09/16/2009
17 11 3 Ishimaru , Osaka, Mino Shi JAPAN
80 F - - MT Warmer, Infant Radiant
Date Published: 09/16/2009

Notes: Infant Heel Warmers Infant Crib Warmers 12/27/1994

Miwa Science Corp
Date Published : 11/15/2010
2 4 2 Azaminominami , Kanagawa, JAPAN
79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 11/15/2010

Desc: NARL 517 MS (Beauty Equipment Massager)
Notes: Class III

89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 11/15/2010

Desc: NARL 517 MS (Beauty Equipment Massager)
Notes: Class III

Nippon Germanium Laboratory Co., Ltd.
Date Published : 09/16/2009
2-11-9 Kasuga , Shizuoka, Kasuga JAPAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: Germanium Pellets Bandages 5/20/1996 All devices. DE.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Repro Support Medi
Date Published : 06/15/2016
2-5-5 8f Shinjuku , Tokyo, JAPAN
85 M - - QK Labware, Assisted Reproduction
Date Published: 06/15/2016

Desc: Vitrification Kits

SEKISUI MEDICAL CO LTD
Date Published : 09/30/2021
3262-12 , Oazaami; Ami-Machi , Inashiki-Gun, Ibaraki JAPAN
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/30/2021

Desc: Acucy SARS-CoV-2 Antigen Test with the Acucy System

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Date Published : 01/06/2022
Nishinokyo Kuwabara -Cho , Nakagyo-Ku; 1 , Kyoto, Kyoto JAPAN
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/06/2022

Desc: 2019 Novel Coronavirus Detection Kit

Yaman Ltd
Date Published : 05/20/2022
2 Chome 4-2 , Toyo , Koto, Tokyo JAPAN
89 L - - YG Massager, Therapeutic, Manual
Date Published: 05/20/2022

Desc: Medilift mask

89 L - - YG Massager, Therapeutic, Manual
Date Published: 05/20/2022

Desc: Medilift eye


KOREA (THE REPUBLIC OF)


ABATON IND
Date Published : 07/13/2011
Seojung-Dong , Pyungtaek City, KOREA (THE REPUBLIC OF)
89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 07/13/2011

Desc: Abaton Far Infrared Massage Bed II Models (800 DX; MS and 800 SA)
Notes: Class II

ASAN PHARM CO LTD
Date Published : 09/17/2020
485 Cheonggyecheon-Ro D , Seoul, KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/17/2020

Desc: Asan Easy Test Covid-19 IgG/IgM

83 Q - - KO Reagent, coronavirus serological
Date Published: 09/17/2020

Desc: Asan Easy Test Covid-19 IgG/IgM

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 09/17/2020

Desc: Asan Easy Test Covid-19 IgG/IgM

Absology Co., Ltd.
Date Published : 01/26/2021
Simin-Daero 383, Dongan , # 1303 Digital Empire "B" , Anyang, Gyeonggi KOREA (THE REPUBLIC OF)
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: Absoludy COVID-19 IgM/IgG Combo

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: Absoludy COVID-19 IgM/IgG Rapid

83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: INIST COVID-19 IgM/IgG Rapid

Acmedi Korea Co.
Date Published : 10/23/2018
293 Mokdongdong-Ro , Yangcheon, Seoul KOREA (THE REPUBLIC OF)
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 10/23/2018

Desc: Skin Lifting Device (Plamere)
Notes: Class II device; requires 510(k); or de novo application

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 10/23/2018

Desc: Skin Lifting Device (Plamere)
Notes: Class II device; requires 510(k); or de novo application

79 N - - RJ Ultrasound, Skin Permeation
Date Published: 10/23/2018

Desc: Skin Lifting Device (Plamere)
Notes: Class II device; requires 510(k); or de novo application

80 L - - DQ Device, General Medical
Date Published: 10/23/2018

Desc: Skin Lifting Device (Plamere)
Notes: Class II device; requires 510(k); or de novo application

Across Co., Ltd
Date Published : 08/22/2022
3F, 23, Geodudanji 1-gil , Dongnae-myeon , Chuncheon-si, Gangwon-do KOREA (THE REPUBLIC OF)
60 Q - - 40 Lidocaine HCl (Anesthetic)
Date Published: 08/22/2022

Desc: REVOLAX

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 08/22/2022

Desc: REVOLAX

87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 08/22/2022

Desc: REVOLAX

Aquavit Life Sciences, Inc.
Date Published : 12/28/2021
4th Floor Pankyoyeok-ro , 192 beon-gil 14 Bundang-gu , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF)
79 G - - AA Needle, Aspiration And Injection, Disposable
Date Published: 12/28/2021

Desc: Advance Skin Application Platform Micro Infusion System (ASAP!)

79 G - - AA Needle, Aspiration And Injection, Disposable
Date Published: 12/28/2021

Desc: AQUAGOLD Fine Touch (AQT-001)

79 Q - - AI Powered microneedle device
Date Published: 12/28/2021

Desc: AQUAGOLD Fine Touch (AQT-001)

79 Q - - AI Powered microneedle device
Date Published: 12/28/2021

Desc: Advance Skin Application Platform Micro Infusion System (ASAP!)

BBB INC
Date Published : 07/27/2021
7F, Teheran-ro 81-gil , Gangnam-gu , Seoul, KOREA (THE REPUBLIC OF)
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: MARK-B%u2122 COVID-19 Ag

BNB MEDICAL CO., LTD.
Date Published : 08/22/2011
#404 Hyundai Hyel , 779-11 Jayang-Dong, Gwangjin-Gu , Seoul, KOREA (THE REPUBLIC OF)
79 K - - CX Epilator, High Frequency, Tweezer-Type
Date Published: 08/22/2011

Desc: BND Laser Hair Remover Models W-808 CW-808 (Epila and Venus Laser Hair Removal devices)
Notes: Class II

86 L - - ZS Laser, System, Excimer
Date Published: 08/22/2011

Desc: BND Laser Hair Remover Models W-808 CW-808 (Epila and Venus Laser Hair Removal devices)
Notes: Class II

BOMTECH ELECTRONICS CO., LTD.
Date Published : 05/08/2020
322, Gonghang-daero, , Gangseo-gu , Seoul, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF)
79 Q - - AI Powered microneedle device
Date Published: 05/08/2020

Desc: Tri-M Micro Needle

80 F - - MI Needle, Hypodermic, Single Lumen
Date Published: 05/08/2020

Desc: Tri-M Micro Needle

Bionote, Inc.
Date Published : 03/02/2021
22, Samsung 1-Ro 4-Gil, Hwaseong-Si, , Gyeonggi-do, KOREA (THE REPUBLIC OF)
83 O - - TG Non-sars coronavirus multiplex nucleic acid assay
Date Published: 03/02/2021

Desc: NowCheck COVID-19 Ag Test

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 03/02/2021

Desc: NowCheck COVID-19 Ag Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/02/2021

Desc: NowCheck COVID-19 Ag Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/25/2021

Desc: NowCheck COVID-19 IgM/IgG Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 03/02/2021

Desc: NowCheck COVID-19 Ag Test

Boditech Med, Inc.
Date Published : 10/19/2020
43 Geodudanji1-Gil , Dongnae-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/19/2020

Desc: Ichroma COVID-19 Ab (with ichroma II analyzer)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/07/2021

Desc: ExAmplar COVID-19 real-time PCR kit (L)

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/19/2020

Desc: Ichroma COVID-19 Ab (with ichroma II analyzer)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/19/2020

Desc: Ichroma COVID-19 Ab (with ichroma II analyzer)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/04/2022

Desc: AFIAS COVID-19 Ag (with AFIAS- 6 Analyzer)

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/19/2020

Desc: Ichroma COVID-19 Ab (with ichroma II analyzer)

Bridget Lifescience Co Ltd
Date Published : 11/30/2011
12th Fl., Shinwoong Tower , 719 Yeoksam2-Dong , Gangnam-Gu, SEOUL TEUGBYEOLSI KOREA (THE REPUBLIC OF)
78 N - - ZU Collector, urine, powered, non indwelling catheter
Date Published: 11/30/2011

Desc: Careclean 3000 Personal automatic urine collection system
Notes: Class II

CALTH INC
Date Published : 12/28/2020
7508, 140, Beolmal-Ro , Gyeinggi-Do, KOREA (THE REPUBLIC OF)
83 Q - - KO Reagent, coronavirus serological
Date Published: 12/28/2020

Desc: AccuFind COVID19 IgG

CALTH INC.
Date Published : 12/28/2020
#321, 54, Changeop-Ro,S , Gyeonggi-Do, KOREA (THE REPUBLIC OF)
83 Q - - KO Reagent, coronavirus serological
Date Published: 12/28/2020

Desc: AccuFind COVID19 IgG

CANCERROP
Date Published : 07/17/2020
10f Elysia Bldg 173 , Seoul, KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit

COLORCLSHOP
Date Published : 12/12/2023
COLORCL 351, SUNMOON-RO , TANGJEONG-MYEON , CHUNGCHEONGNAM-DO, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 12/12/2023

Desc: Contact Lenses

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 12/12/2023

Desc: Contact Lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 12/12/2023

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 12/12/2023

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 12/12/2023

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 12/12/2023

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 12/12/2023

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 12/12/2023

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 12/12/2023

Desc: Contact Lenses

COSRX INC
Date Published : 09/04/2019
Bundangemtawo , 8 Gumi-Ro; Bundang , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF)
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/04/2019

Desc: Acne Pimple Master Patch
Notes: Class I device without a valid 510k

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/04/2019

Desc: Acne Pimple Master Patch
Notes: Class I device without a valid 510k

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 09/04/2019

Desc: Acne Pimple Master Patch
Notes: Class I device without a valid 510k

53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/04/2019

Desc: Acne Pimple Master Patch
Notes: Class I device without a valid 510k

64 D - - 01 Carboxymethylcellulose Sodium, Emollient,Lubricant
Date Published: 09/04/2019

Desc: Acne Pimple Master Patch
Notes: Class I device without a valid 510k

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/04/2019

Desc: Acne Pimple Master Patch
Notes: Class I device without a valid 510k

79 N - - AC Dressing, Wound, Hydrophilic
Date Published: 05/28/2021

Desc: Acne Pimple Master Patch
Notes: Class I device without a valid 510k

79 N - - AD Dressing, Wound, Occlusive
Date Published: 05/28/2021

Desc: Acne Pimple Master Patch
Notes: Class I device without a valid 510k

Caregen Co., Ltd.
Date Published : 04/15/2022
270 Gongdan-Ro , Gunpo, Gyeonggi KOREA (THE REPUBLIC OF)
78 M - - RE Solution, Sodium Hyaluronate
Date Published: 04/15/2022

Desc: Revofil Ultra

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 04/15/2022

Desc: Revofil Ultra

Ceragem Medisys In
Date Published : 06/03/2015
16, Jeongjai-Gil, , Cheonan-si, KOREA (THE REPUBLIC OF)
79 G - - EX Powered laser surgical instruments
Date Published: 06/03/2015

Desc: OCimple Light Therapy System
Notes: class II

79 O - - LP Over-the-counter powered red/blue light based laser for acne
Date Published: 06/03/2015

Desc: OCimple Light Therapy System
Notes: class II

Choyang Medical Co Ltd
Date Published : 09/16/2009
4515 Woeburi Kunbukmeon , Chungnam, KOREA (THE REPUBLIC OF)
89 I - - RT Pad, Heating, Powered
Date Published: 09/16/2009

Notes: Choyand Dana CY5000 Physical Therapy Table; Choyang Dana Muscle Stimulator; Choyang Dana CY1000 Muscle Stimulator; Choyang Dana JO EUN A CIM (Delux Heating Pad) Choyang Dan EUN A CIM (Regular Heating Pad) 4/23/2003.

89 J - - FB Table, Physical Therapy, Multi Function
Date Published: 09/16/2009

Notes: Choyand Dana CY5000 Physical Therapy Table; Choyang Dana Muscle Stimulator; Choyang Dana CY1000 Muscle Stimulator; Choyang Dana JO EUN A CIM (Delux Heating Pad) Choyang Dan EUN A CIM (Regular Heating Pad) 4/23/2003.

89 M - - PH Stimulator, Electrical, Muscle
Date Published: 09/16/2009

Notes: Choyand Dana CY5000 Physical Therapy Table; Choyang Dana Muscle Stimulator; Choyang Dana CY1000 Muscle Stimulator; Choyang Dana JO EUN A CIM (Delux Heating Pad) Choyang Dan EUN A CIM (Regular Heating Pad) 4/23/2003.

Con Tech Korea Co. Ltd.
Date Published : 06/13/2014
Chunnan Techno College,Post Bi-A203 , Wolchul, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 06/13/2014

Desc: Contact Lenses

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 06/13/2014

Desc: Contact Lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 06/13/2014

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 06/13/2014

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 06/13/2014

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 06/13/2014

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 06/13/2014

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 06/13/2014

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 06/13/2014

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 06/13/2014

Contech Korea
Date Published : 06/13/2014
970-14 Wolchul-Dong , Gwangju, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 06/13/2014

Desc: Contact Lenses

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 06/13/2014

Desc: Contact Lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 06/13/2014

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 06/13/2014

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 06/13/2014

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 06/13/2014

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 06/13/2014

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 06/13/2014

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 06/13/2014

Desc: Contact Lenses

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 06/13/2014

Desc: Contact Lenses

DFI CO., LTD.
Date Published : 01/04/2016
388-25 Gomo-Ro , Jinrye-Myeon , Gimhae, Gyeongsangnam KOREA (THE REPUBLIC OF)
75 M - - XA System, Test, Breath Nitric Oxide
Date Published: 01/04/2016

Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS

91 M - - IG Strip, Test Isoniazid
Date Published: 01/04/2016

Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS

DFI Co. Ltd
Date Published : 01/04/2016
542-1 Daman-Ri, Jinrye-Myun , Gimhae, KOREA (THE REPUBLIC OF)
75 M - - XA System, Test, Breath Nitric Oxide
Date Published: 01/04/2016

Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS

91 M - - IG Strip, Test Isoniazid
Date Published: 01/04/2016

Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS

DK Innovision Co., Ltd
Date Published : 10/29/2013
23 Busong1-Gil , Seobuk , Cheonan, Chungcheongnam KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/29/2013

Desc: Color Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/29/2013

Desc: Color Contact Lenses
Notes: Class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/29/2013

Desc: Color Contact Lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/29/2013

Desc: Color Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/29/2013

Desc: Color Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/29/2013

Desc: Color Contact Lenses
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/29/2013

Desc: Color Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/29/2013

Desc: Color Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/29/2013

Desc: Color Contact Lenses
Notes: class II

DNA LINK, INC
Date Published : 12/28/2020
2f Cluster Center , Seoul, KOREA (THE REPUBLIC OF)
83 Q - - KO Reagent, coronavirus serological
Date Published: 12/28/2020

Desc: AccuFind COVID19 IgG

DOWGENE DNA TESTING COMPANY
Date Published : 06/08/2022
Rm 513 Ace High End Tow , Seoul, KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: Dow QuickFinder 2019-nCoV Real-Time PCR kit

DXGEN CORP
Date Published : 03/11/2021
303 1 Hanlim Huma , Gunpo Si, KOREA (THE REPUBLIC OF)
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: EDGC RapidCheck COVID-19 IgG Test Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: Epithod 616 COVID-19 IgG Test Kit and EDGC RapidCheck COVID-19 IgG Test Kit

DongBang Medical Co. Ltd.
Date Published : 10/22/2015
30 Saneopdanji-Gil , Ungcheon-Eup , Boryeong, Chungcheongnam KOREA (THE REPUBLIC OF)
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/21/2016

Desc: Derma-Q For Microneedle
Notes:                                                                                                       

79 G - - AB Needle, Suturing, Disposable
Date Published: 10/22/2015

Desc: Dermapen Needle
Notes: The device has no 510(k) clearance or PMA approval

79 M - - DM Instrument, Manual, General Surgical
Date Published: 04/21/2016

Desc: Derma-Q For Microneedle
Notes:                                                                                                       

Dongbang Acupuncture Inc
Date Published : 10/22/2015
Woorim W-City 313 Sam Pyung Dong , Seongnam-Si, KOREA (THE REPUBLIC OF)
79 G - - AB Needle, Suturing, Disposable
Date Published: 10/22/2015

Desc: Dermapen Needle
Notes: The device has no 510(k) clearance or PMA approval

DreamCon Co. Ltd.
Date Published : 06/16/2016
Gyeongsangnam , 8 Yeongdong2-Gil , Yangsan, Gyeongsangnam KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 06/16/2016

Desc: Contact Lenses

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 06/16/2016

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 06/16/2016

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 06/16/2016

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 06/16/2016

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 06/16/2016

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 06/16/2016

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 06/16/2016

Desc: Contact Lenses

E.O.S. Co Ltd
Date Published : 12/06/2010
Horimdong 98 5 , Taegu, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

EOFE ULTRASONICS CO LTD
Date Published : 08/04/2023
303 Venture Center, 76 , Goyang-Si, KOREA (THE REPUBLIC OF)
79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 08/04/2023

Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device

80 F - - LG Cleaner, Ultrasonic, Medical Instrument
Date Published: 08/04/2023

Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device

85 H - - GL Transducer, Ultrasonic, Obstetric
Date Published: 08/04/2023

Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device

90 I - - TX Transducer, Ultrasonic, Diagnostic
Date Published: 08/04/2023

Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device

EYEMERA CO LTD
Date Published : 12/26/2023
Dalseo Gu , Seoul , Doum 5-Ro, KOREA (THE REPUBLIC OF)
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 12/26/2023

Desc: Contact Lenses
Notes: Contacts lenses packaged in plastic clamshell cases (blister packs) are subject to DWPE; glass vials are exempt from DWPE under this listing.

EYEMERA Co., Ltd.
Date Published : 12/26/2023
146 Seongseo4chacheomdan-Ro , Dalseo, Daegu KOREA (THE REPUBLIC OF)
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 12/26/2023

Desc: Contact Lenses
Notes: Contacts lenses packaged in plastic clamshell cases (blister packs) are subject to DWPE; glass vials are exempt from DWPE under this listing.

Enskin
Date Published : 10/11/2013
210 C-Dong, 145 Bundang Techo Park , Sungnam, Gyeonggi KOREA (THE REPUBLIC OF)
80 M - - QX Needle, Acupuncture, Single Use
Date Published: 10/11/2013

Desc: Skin Stamp
Notes: Class II

Eunsung Global Corp
Date Published : 09/08/2015
1102 1105 Hanrasigma Valley Gasa , Seoul, FN KOREA (THE REPUBLIC OF)
79 G - - AA Needle, Aspiration And Injection, Disposable
Date Published: 09/08/2015

Desc: Needle; Aspiration And Injection; Disposable
Notes: Class III; Vital Injector 2

Eyepia Medicals
Date Published : 09/21/2015
3f 325-22 Danjeong Dont , Gyeonnggi-Do, KOREA (THE REPUBLIC OF)
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 09/21/2015

Desc: Contact lenses
Notes: Class II

G & G Contact Lens Co.
Date Published : 11/18/2011
4 Fl., Bummel Building 1287-1 , Bummel-Dong, Susung-Gu , Daegu, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 02/03/2016

Desc: Soft cosmetic contact lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 02/03/2016

Desc: Soft cosmetic contact lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 02/03/2016

Desc: Soft cosmetic contact lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 02/03/2016

Desc: Soft cosmetic contact lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 11/18/2011

Desc: Contact Lens
Notes: class II/III

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 02/03/2016

Desc: Soft cosmetic contact lenses

86 M - - ZD System, In-Office Tinting, Contact Lenses
Date Published: 01/30/2019

Desc: Circle Lenses
Notes: Class II; 7/27/2010

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 02/03/2016

Desc: Soft cosmetic contact lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 02/03/2016

Desc: Soft cosmetic contact lenses

GC Cell Corp
Date Published : 07/27/2021
107 Ihyeonro30beon-Gil; Giheung , Yongin, Gyeonggi KOREA (THE REPUBLIC OF)
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: GENEDIA W COVID-19 Ag

GCS GROUP CO LTD
Date Published : 10/23/2018
1008 Ho Sunil Technopark Bldg , 555 Dunchondae-Ro; Jungwon , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF)
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/14/2022

Desc: Leaf Fusion Plasma

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 10/23/2018

Desc: Skin Lifting Device (Plamere)
Notes: Class II device; requires 510(k); or de novo application

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 11/14/2022

Desc: Leaf Fusion Plasma

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 09/23/2022

Desc: Plaxpot (Model GPX-2000)

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 10/23/2018

Desc: Skin Lifting Device (Plamere)
Notes: Class II device; requires 510(k); or de novo application

79 N - - RJ Ultrasound, Skin Permeation
Date Published: 10/23/2018

Desc: Skin Lifting Device (Plamere)
Notes: Class II device; requires 510(k); or de novo application

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/14/2022

Desc: Leaf Fusion Plasma

89 I - - SA Massager, Therapeutic, Electric
Date Published: 02/24/2022

Desc: Skin Lifting Device (Plamere)
Notes: Class II device; requires 510(k); or de novo application. DWPE Date: 10/23/2018

GENBODY INC
Date Published : 04/29/2021
3-18 Eopseong 2- Gil, , Seobuk-gu, , Cheonan, Chungnam KOREA (THE REPUBLIC OF)
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/29/2021

Desc: COVID-19 IgM/IgG

GENOMICTREE
Date Published : 11/29/2022
44-6 Techno 10-Ro , Yuseong-gu , Daejon, DAEJEON GWANGYEOGSI, KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/29/2022

Desc: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR)

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/29/2022

Desc: SARS-CoV-2 Real-TM

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/29/2022

Desc: AccuraDTect SARS-CoV-2 RT-qPCR Kit

GS STANDARD ENG
Date Published : 11/29/2010
1006, BYUCKSAN 2CHA, 481-10 , GASAN-DONG, GEUMCHEON-GU , SEOUL, KOREA (THE REPUBLIC OF)
53 - - - -- Cosmetics
Date Published: 11/29/2010

Desc: Mesotherapy Roller
Notes: Class II

79 G - - ED Brush, Dermabrasion, Manual
Date Published: 11/29/2010

Desc: Mesotherapy Roller
Notes: Class II

80 F - - MI Needle, Hypodermic, Single Lumen
Date Published: 11/29/2010

Desc: Mesotherapy Roller
Notes: Class II

Green Cross Corp_Eumseong Plant
Date Published : 07/27/2021
26 Mugeukro65beon-Gil , Geumwang-Eup , Eumseong, Chungcheongbuk KOREA (THE REPUBLIC OF)
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: GENEDIA W COVID-19 Ag

Hesung Medical Supply Co., Ltd.
Date Published : 09/16/2009
517-4 Sangdaewon-Dong , Seongname City, KOREA (THE REPUBLIC OF)
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE. Scalp Vein Infusion Sets.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Humasis Co Ltd
Date Published : 04/20/2022
RM.114,502,504,604-1,B03-01,B03-02,88 , JEONPA-RO,DONGAN-GU , ANYANG-SI, GYEONGGIDO KOREA (THE REPUBLIC OF)
83 Q - - KO Reagent, coronavirus serological
Date Published: 04/20/2022

Desc: SARS-CoV-2 IgG/IgM Antibody Test

ICK Co. Ltd.
Date Published : 02/16/2016
2F, Hyundai Town (727-2, Gojian-dong) , 99 Kwangdukdong-ro, Danwon-ku , Ansan-si, Gyeonggi-do KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 02/16/2016

Desc: Contact Lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 02/16/2016

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 02/16/2016

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 02/16/2016

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 02/16/2016

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 02/16/2016

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 02/16/2016

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 02/16/2016

Desc: Contact Lenses

IONEBIO INC
Date Published : 12/07/2021
#1008-1012, Seongnam Central Biz Tower , 314, Galmachi-ro, Jungwon-gu , Seongnam-si, Gyeonggi-do KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 12/07/2021

Desc: iLAMP Novel-CoV19 Detection Kit

Interojo Inc.
Date Published : 05/23/2016
28 & 25 Sandan-Ro 15 Beon-Gil , Pyeongtaek City, Gyeonggi KOREA (THE REPUBLIC OF)
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 05/23/2016

Desc: Morning Q Ultra Soo 55 contact lenses
Notes:                                                                                                                                                                                                                  

86 M - - VN Lens, Contact (Disposable)
Date Published: 05/23/2016

Desc: Morning Q Ultra Soo 55 contact lenses
Notes:                                                                                                                                                                                                                 

Kyungwon Medical Co., Ltd.
Date Published : 01/27/2016
765, Jeongjungyeonje-ro , Osong-eup, Chungcheongbuk-do KOREA (THE REPUBLIC OF)
87 M - - BP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Date Published: 11/08/2018

Desc: PolyBone Original (Bone Graft Substitute)

87 M - - QV Filler, Calcium Sulfate Preformed Pellets
Date Published: 01/27/2016

Desc: PolyBone Original (Bone Graft Substitute)

LABGENOMICS CO LTD
Date Published : 12/07/2021
6f B-Wing Korea Bio Par , Seongnam-City, KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 12/07/2021

Desc: LabGun COVID-19 ExoFast RT-PCR Kit

LAON CO, LTD
Date Published : 10/29/2013
Siwha Industrial Complex , 2172-5 Jeongwang-Dong , Siheung, KOREA (THE REPUBLIC OF)
80 M - - QX Needle, Acupuncture, Single Use
Date Published: 10/29/2013

Desc: Microneedle Therapy System
Notes: Class II

Lensmam Co. Ltd
Date Published : 07/31/2012
Rm. 304 & 305. Pos Techno. Sangdaewon 1- , dong, Jungwon-gu, Seongnam-si , Gyeonggi-do, Seongnam-si KOREA (THE REPUBLIC OF)
73 - - - -- Anesthesiology
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

74 - - - -- Cardiovascular
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

76 - - - -- Dental
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

77 - - - -- Ear,Nose And Throat
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

78 - - - -- Gastroenterological & Urological
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

79 - - - -- General & Plastic Surgery
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

80 - - - -- General Hospital/Personal Use
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

84 - - - -- Neurological
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

85 - - - -- Obstetrical & Gynecological
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

86 - - - -- Ophthalmic
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

87 - - - -- Orthopedic
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

89 - - - -- Physical Medicine
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

90 - - - -- Radiology
Date Published: 07/31/2012

Notes: All device products; Class I/II/III

M.I. TECH
Date Published : 04/12/2023
65 #616, Hanshin S-Meca , Yuseong, DAEJEON KOREA (THE REPUBLIC OF)
79 G - - FE Brush, Dermabrasion
Date Published: 04/12/2023

Desc: CytoPen Nano Pen

79 Q - - AI Powered microneedle device
Date Published: 04/12/2023

Desc: CytoPen Nano Pen

MICOBIOMED CO., LTD.
Date Published : 06/08/2022
54 3, 4th Floor , Seongnam , Changeop-Ro, Sujeong, KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: Veri-Q COVID-19 Multiplex Assay Kits

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/08/2022

Desc: Kairogen covid-19 antigen rapid test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/08/2022

Desc: VERI-Q COVID-19 Ag Rapid Test

Megatrend International
Date Published : 12/06/2010
207 Seowoo Bldg #497sangdo-1dong , Dongjak-kudongjak-ku, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 12/06/2010

Desc: Class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 12/06/2010

Desc: Contact Lenses (Circle Lenses)
Notes: Class II

Metro Korea Co Ltd
Date Published : 07/13/2012
56-10 Nonhyun-Dongkangnam-Guseoul , Seoulseoul, KOREA (THE REPUBLIC OF)
79 G - - EY Motor, Surgical Instrument, Ac-Powered
Date Published: 07/13/2012

Desc: Meta Duo Beauty Device
Notes: Class II

79 O - - UH Skin resurfacing rf applicator
Date Published: 07/13/2012

Desc: Meta Duo Beauty Device
Notes: Class II

NDFOS CO LTD
Date Published : 03/11/2021
1-Dong 705-Ho, Innoplex Bldg. 306, Sinwon-Ro, Yeongtong-Gu , Suwon-Si, Gyeonggido KOREA (THE REPUBLIC OF)
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/11/2021

Desc: ND COVID-19 IgG/IgM Rapid Test

Neo Vision Co Ltd
Date Published : 11/09/2012
129-1 Donghwagongdan-ro , Munmak-Eup, Wonju-si , Yongin, Gangwon-do KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 M - - VN Lens, Contact (Disposable)
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

Neo Vision Co., Ltd.
Date Published : 11/09/2012
93 Jeungsin-Ro , Icheon, Gyeonggi KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 M - - VN Lens, Contact (Disposable)
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.

Neobiotech Co., Ltd.
Date Published : 08/09/2018
#1001, 36, DIGITAL-RO 27 GIL , 103, e-space, 212-26, Guro-dong , Guro-gu, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF)
76 L - - YC Bone Grafting Material, Synthetic
Date Published: 08/09/2018

Desc: "RegenOss" Freeze Dried Bone Allograft
Notes: Class III; 9/25/2009

Nuga Medical Co., Ltd.
Date Published : 09/16/2009
185 Jiraeul-Lo , Jijeong-Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF)
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 09/16/2009

Notes: Nuga Best NM5000 4/19/2005

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Nuga Best NM5000 4/19/2005

89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/16/2009

Notes: Nuga Best NM5000 4/19/2005

89 M - - PH Stimulator, Electrical, Muscle
Date Published: 09/16/2009

Notes: Nuga Best NM5000 4/19/2005

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes: Nuga Best NM5000 4/19/2005

PCL INC
Date Published : 06/22/2021
Rm 701 Star Valley 99 Digital-Ro 9-Gil , Geumcheon, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF)
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2021

Desc: PCL COVID19 Ag Rapid FIA

PLEXENSE, INC
Date Published : 01/26/2021
Giheung , 1301 1302, 1303 16-4 Dongbaekjungang-Ro , Yongin, Gyeonggi KOREA (THE REPUBLIC OF)
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: ACCEL ELISA COVID-19

Polytouch Co Ltd
Date Published : 11/20/2014
108-1 Hyeopseok-Ri Namcheon-Myeon , Gyeongsan-si, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 11/20/2014

Desc: Contact Lenses
Notes: Class 2

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 11/20/2014

Desc: Contact Lenses
Notes: class 2

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 11/20/2014

Desc: Contact Lenses
Notes: class 2

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 11/20/2014

Desc: Contact Lenses
Notes: class 2

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 11/20/2014

Desc: Contact Lenses
Notes: class 2

86 M - - VN Lens, Contact (Disposable)
Date Published: 11/20/2014

Desc: Contact Lenses
Notes: class 2

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 11/20/2014

Desc: Contact Lenses
Notes: class 2

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 11/20/2014

Desc: Contact Lenses
Notes: class 2

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 11/20/2014

Desc: Contact Lenses
Notes: class 2

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 11/20/2014

Desc: Contact Lenses
Notes: class 2

Rsk Med Technologies Co.,Ltd.
Date Published : 02/13/2013
No. 405, 1310-8, Yeonsan5dong, Yeonjegu , Busan, KOREA (THE REPUBLIC OF)
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 05/11/2021

Desc: X-Cure skin pricking instrument with needles
Notes: Class II; 2/13/2013

79 G - - FE Brush, Dermabrasion
Date Published: 05/11/2021

Desc: X-Cure skin pricking instrument with needles
Notes: Class II; 2/13/2013

79 O - - UH Skin resurfacing rf applicator
Date Published: 05/11/2021

Desc: X-Cure skin pricking instrument with needles
Notes: Class II; 2/13/2013

84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief
Date Published: 05/11/2021

Desc: X-Cure skin pricking instrument with needles
Notes: Class II; 2/13/2013

84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes
Date Published: 05/11/2021

Desc: X-Cure skin pricking instrument with needles
Notes: Class II; 2/13/2013

89 I - - SA Massager, Therapeutic, Electric
Date Published: 05/11/2021

Desc: X-Cure skin pricking instrument with needles
Notes: class II; 2/13/2013

SEOULIN MEDICARE C
Date Published : 02/09/2022
4th Floor Seoulinglobal Center , 593-16 Dongtangiheung-Ro , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF)
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/09/2022

Desc: Profacial solution

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/09/2022

Desc: Sono Machine

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/09/2022

Desc: Plasma Machine

79 G - - FE Brush, Dermabrasion
Date Published: 02/09/2022

Desc: Profacial solution

79 G - - FE Brush, Dermabrasion
Date Published: 02/09/2022

Desc: Sono Machine

79 G - - FE Brush, Dermabrasion
Date Published: 02/09/2022

Desc: Plasma Machine

89 I - - SA Massager, Therapeutic, Electric
Date Published: 02/09/2022

Desc: Sono Machine

89 I - - SA Massager, Therapeutic, Electric
Date Published: 02/09/2022

Desc: Profacial solution

89 I - - SA Massager, Therapeutic, Electric
Date Published: 02/09/2022

Desc: Plasma Machine

SKINREX CO., LTD
Date Published : 11/25/2013
507HO JOONGANDINDUSPIA 2 , 144-5 SANGDAEWON-DONG, JUNGWON-GU , SEONGNAM-SI, KOREA (THE REPUBLIC OF)
89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/25/2013

Desc: Cavi-Lipo Massager
Notes: Class III

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/27/2016

Desc: Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT

89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 11/25/2013

Desc: Cavi-Lipo Massager
Notes: Class III

89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 04/27/2016

Desc: Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT

SLSBIO CO LTD
Date Published : 10/21/2020
Gwanggyo Central Biz To , Suwon, KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/21/2020

Desc: SsmarTest COVID-19 IgM/IgG Detection Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/21/2020

Desc: SsmarTest COVID-19 IgM/IgG Detection Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/21/2020

Desc: SsmarTest COVID-19 IgM/IgG Detection Kit

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/21/2020

Desc: SsmarTest COVID-19 IgM/IgG Detection Kit

SONIC WORLD CO., LTD.
Date Published : 11/20/2015
131 Donghwagongdan-ro , Wonju-si, Gangwon-do KOREA (THE REPUBLIC OF)
89 B - - XB Exerciser, Powered
Date Published: 11/20/2015

Desc: Sonix Whole Body Vibration Machines
Notes: Models VM-10, VH-11, and VC-12. Labels and labeling may bear the address of: 1- 125, Wonju Medical Industry Techno Park, 1720-26, Taejang-dong, Wonju-si, Gangwon-do, Korea.

SUNWOO I&T
Date Published : 09/09/2013
1f, 371-22 Kongkoo B/D , Shinsoo-Dong, Mapo-Gu , Seoul, Seoul KOREA (THE REPUBLIC OF)
79 G - - FE Brush, Dermabrasion
Date Published: 09/09/2013

Desc: Dermapen
Notes: class II

Saeik Medical Co., Ltd.
Date Published : 08/10/2011
156-8, Chuneui-Dong, Wonmi-Ku , Wonmi-Ku , Bucheon City, Gyeonggi-Do KOREA (THE REPUBLIC OF)
84 H - - CC Device, Biofeedback
Date Published: 08/10/2011

Desc: eLIFE Electric Field Health Instrument
Notes: Class; II

Sambo Ventec Corp
Date Published : 02/25/2013
535-2 Dong Pae Ri Gyo Ha Myen , Paju City Kyung Gi Do, KOREA (THE REPUBLIC OF)
73 C - - BF Chamber, Hyperbaric
Date Published: 02/25/2013

Desc: Hyperbaric Oxygen Chamber
Notes: class II

79 K - - PJ Chamber, Oxygen, Topical, Extremity
Date Published: 02/25/2013

Desc: Hyperbaric Oxygen Chamber
Notes: Class II

Seegene Inc.
Date Published : 12/03/2021
Taewonbilding , 7 F Taewon B/Dsongpa; 91 Ogeum-Ro , Songpa, Seoul KOREA (THE REPUBLIC OF)
83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 12/03/2021

Desc: Allplex SARS-CoV- 2/FluA/FluB/RSV Assay (Cat No. RV10260Y; RV10259X)

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 12/03/2021

Desc: Allplex SARS-CoV- 2/Flu/RSV Assay (Cat No. RV10274X; RV10277Y)

Seju Engineering Co., Ltd.
Date Published : 09/16/2009
611-1, Guam-Dong , Yusung-Gu , Daejon City, Chuongnam, KOREA (THE REPUBLIC OF)
91 D - - JZ Devices, Breath Trapping, Alcohol
Date Published: 09/16/2009

Notes: Digital Alcohol Detector 8/28/2007

Silgreen Inc.
Date Published : 01/24/2012
396-2, Daebang-Dong, Dongjak-Ku , Seoul, KOREA (THE REPUBLIC OF)
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 01/24/2012

Desc: Iontophoresis device for non-CF diagnosis (Skin care appliance)
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/24/2012

Desc: Iontophoresis device for non-CF diagnosis (Skin care appliance)
Notes: Class II

Standard Diagnostics, Inc
Date Published : 05/17/2012
156-68 Hagai-Ri, Giheung-Eup, Yongin-Ei , Kyonggi-Do, KOREA (THE REPUBLIC OF)
57 V - - 11 Human Immunodeficiency Virus Type 1
Date Published: 05/17/2012

Desc: SD Bioline HIV 1/2 3/0 test kit
Notes: Class II

57 V - - 13 Human Immunodeficiency Virus Type 2
Date Published: 05/17/2012

Desc: SD Bioline HIV 1/2 3/0 test kit
Notes: Class II

57 V - - 14 Human Immunodeficiency Virus Types 1 & 2
Date Published: 05/17/2012

Desc: SD Bioline HIV 1/2 3/0 test kit
Notes: Class II

81 M - - TK Kit, Sample Collection, HIV
Date Published: 05/17/2012

Desc: SD Bioline HIV 1/2 3/0 test kit
Notes: Class II

81 M - - TL Monitor, Test, HIV-1
Date Published: 05/17/2012

Desc: SD Bioline HIV 1/2 3/0 test kit
Notes: Class II

81 M - - VZ System, Test, Home, HIV-1
Date Published: 05/17/2012

Desc: SD Bioline HIV 1/2 3/0 test kit
Notes: Class II

82 M - - ZF Test, HIV Detection
Date Published: 05/17/2012

Desc: SD Bioline HIV 1/2 3/0 test kit
Notes: Class II

82 N - - HS Assay, Genotype, HIV Drug Resistance, In Vitro
Date Published: 05/17/2012

Desc: SD Bioline HIV 1/2 3/0 test kit
Notes: class II

Sugentech, Inc.
Date Published : 07/27/2021
721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu , 187, techno 2-ro, yuseong-gu , Cheongju, Chungcheongbug KOREA (THE REPUBLIC OF)
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: SGTi-flex COVID-19 Ag

TCM BIOSCIENCES
Date Published : 06/08/2022
3rd Fl, Bldg3, 15 Pangy , Gyeonggi-Do, KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: TCM-Q Corona III Kit

TOPTEC CO. LTD.
Date Published : 03/24/2022
122 Asanvalley-Ro , Dunpo-Myeon , Asan-Si, CHUNGCHEONGNAMDO KOREA (THE REPUBLIC OF)
80 F - - XX Mask, Surgical
Date Published: 03/24/2022

Desc: Air Queen Nano Mask

80 F - - XX Mask, Surgical
Date Published: 03/24/2022

Desc: Nano Mask

The Standard Company
Date Published : 11/29/2010
1007 Byucksan 2cha, 481-10 , Gasan-Dong, Geumcheaon-Gu , Seoul, KOREA (THE REPUBLIC OF)
53 - - - -- Cosmetics
Date Published: 11/29/2010

Desc: Mesotherapy Roller
Notes: Class II

79 G - - ED Brush, Dermabrasion, Manual
Date Published: 11/29/2010

Desc: Mesotherapy Roller
Notes: Class II

80 F - - MI Needle, Hypodermic, Single Lumen
Date Published: 11/29/2010

Desc: Mesotherapy Roller
Notes: Class II

Theg Korea, Inc.
Date Published : 07/27/2010
Suite 1508 Taechidong 889 5 , Seoul, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF)
86 - - - -- Ophthalmic
Date Published: 07/27/2010

Desc: All Contact Lenses
Notes: Class II ; III

Theg Korea, Inc.
Date Published : 07/27/2010
726-74 Hannam-Dong, Suit 1009, , Seoul, KOREA (THE REPUBLIC OF)
86 - - - -- Ophthalmic
Date Published: 07/27/2010

Desc: All Contact Lenses
Notes: Class II; III

Totra Co., Ltd.
Date Published : 06/07/2017
248 Jeosantaeseong-Ro , Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF)
53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations)
Date Published: 06/07/2017

Desc: Callas Charming Double Eyelid Tape
Notes: Device Classification is unknown. The Double Eyelid Tape appears to exceed the limitations of exemptions for 21CFR 880.5240 as the device is intended for a different intended use (i.e., to permanently reshape the eyelids rather than to cover/protect wounds, to hold together skin edges of a wound, to support an injured part of the body, or to secure objects to the skin).                                                                                                                                                                                                                                                                                                                                                                          

80 K - - GX Tape and Bandage, Adhesive
Date Published: 06/07/2017

Desc: Callas Charming Double Eyelid Tape
Notes: Device Classification is unknown. The Double Eyelid Tape appears to exceed the limitations of exemptions for 21CFR 880.5240 as the device is intended for a different intended use (i.e., to permanently reshape the eyelids rather than to cover/protect wounds, to hold together skin edges of a wound, to support an injured part of the body, or to secure objects to the skin).                                                                                                                                                                                                                                                                                                                                                                          

Ugs
Date Published : 04/30/2012
302 Gwangwoo Bd 24-5 Jayang 4 Dong Gwang , Seoul, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 04/30/2012

Desc: Color Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 04/30/2012

Desc: Color Contact Lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 04/30/2012

Desc: Color Contact Lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 04/30/2012

Desc: Color Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 04/30/2012

Desc: Color Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 04/30/2012

Desc: Color Contact Lenses
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 04/30/2012

Desc: Color Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 04/30/2012

Desc: Color Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 04/30/2012

Desc: Color Contact Lenses
Notes: class II

Unis Medical Electronics Co Ltd
Date Published : 09/16/2009
Rm 508 Dae Kwang Bldg 7-15 , Nonhyun-Dong, Xangnam-Ku , Seoul, KOREA (THE REPUBLIC OF)
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. DWI=DE. Heparin Lock (PRN) Protected Needle Adaptor(PNA)IV In- Line Connector Multiple Sample Luer Adaptor. 3/5/1993.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Vassen Co. Ltd.
Date Published : 11/18/2011
260-1 Habuk-Ri Jinwee-Myun , Pyongtaek City, Gyeonggi-di KOREA (THE REPUBLIC OF)
86 M - - VN Lens, Contact (Disposable)
Date Published: 11/18/2011

Desc: Contact Lens
Notes: class II/III

Viss Beauty(Narian Global)
Date Published : 10/10/2013
Hwagok 4 Dong 212 , Seoul, Seoul KOREA (THE REPUBLIC OF)
79 N - - RJ Ultrasound, Skin Permeation
Date Published: 10/10/2013

Desc: VISS Sonic Microdermabrasion Machine
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/10/2013

Desc: VISS Sonic Microdermabrasion Machine
Notes: Class II

WIZBIOSOLUTIONS
Date Published : 11/24/2021
A-802 Woolim Lions Valley 2 , Sagimakgol-ro, 45beon-gil 14, Jungwon-gu , Seongnam, KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva

Winners Co., Ltd.
Date Published : 05/10/2012
2F, 76-1, Yeongtong-dong , Yeongtong-gu , Suwon-Si, GyeongGi-Dong KOREA (THE REPUBLIC OF)
73 - - - -- Anesthesiology
Date Published: 05/10/2012

Notes: All medical devices; class II

74 - - - -- Cardiovascular
Date Published: 05/10/2012

Notes: All medical devices; class II

76 - - - -- Dental
Date Published: 05/10/2012

Notes: All medical devices; class II

77 - - - -- Ear,Nose And Throat
Date Published: 05/10/2012

Notes: All medical devices; class II

78 - - - -- Gastroenterological & Urological
Date Published: 05/10/2012

Notes: All medical devices; class II

79 - - - -- General & Plastic Surgery
Date Published: 05/10/2012

Notes: All medical devices; class II

80 - - - -- General Hospital/Personal Use
Date Published: 05/10/2012

Notes: All medical devices; class II

84 - - - -- Neurological
Date Published: 05/10/2012

Notes: All medical devices; class II

85 - - - -- Obstetrical & Gynecological
Date Published: 05/10/2012

Notes: All medical devices; class II

86 - - - -- Ophthalmic
Date Published: 05/10/2012

Notes: All medical devices; class II

87 - - - -- Orthopedic
Date Published: 05/10/2012

Notes: All medical devices; class II

89 - - - -- Physical Medicine
Date Published: 05/10/2012

Notes: All medical devices; class II

90 - - - -- Radiology
Date Published: 05/10/2012

Notes: All medical devices; class II

Won Industry Co. LTD
Date Published : 12/15/2016
Wonsaneop , 7-12 Bangadari-Gil , Siheung, Gyeonggi KOREA (THE REPUBLIC OF)
89 I - - RP Massager, Powered Inflatable Tube
Date Published: 12/15/2016

Desc: Morning Life Compression Limb Therapy System
Notes: Class II device without a valid 510k

YD Diagnostics
Date Published : 06/08/2022
No. 173 Seo-Ri , Yidong-Myun, Choin-Gu , Yongin-Si, KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: MolecuTech Real- Time COVID-19

Yd Diagnostics Corp.
Date Published : 06/08/2022
76 Seori-Rd, Idong-Myeon, Cheoin-Gu , Yongin-si, Gyeonggi-do KOREA (THE REPUBLIC OF)
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: MolecuTech Real- Time COVID-19

Young Chemical Co., Ltd.
Date Published : 06/08/2017
80-93 Golden Root-Ro , Juchon-Myeon , Gimhae-Si, Gyeongnam KOREA (THE REPUBLIC OF)
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 06/08/2017

Desc: Acne Pimple Master Patch
Notes: Class I device without a valid 510k

79 N - - AC Dressing, Wound, Hydrophilic
Date Published: 06/08/2017

Desc: Acne Pimple Master Patch
Notes: Class I device without a valid 510k

Z Biotech Inc.
Date Published : 07/27/2021
#1409, 134, Gongdan-Ro , Heungdeok-Gu , Cheongju-Si, Chungcheongbuk-do KOREA (THE REPUBLIC OF)
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: RAPID TEST KIT

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: COVID-19 Ag RDT Test Kit

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: ANW COVID-19 Ag RDT Test Kit


LATVIA


Advaita International Ltd
Date Published : 01/23/2013
Karla Ulmana Gatve 2a , Riga, Rigas Rajons LATVIA
89 L - - YG Massager, Therapeutic, Manual
Date Published: 01/23/2013

Desc: Isabella Therapeutic Massage Mat
Notes: Class II


LITHUANIA


Jurdas
Date Published : 08/25/2017
Savanoriu pr. 65-2 , Vilnius, Vilniaus LITHUANIA
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/25/2017

Desc: Peni Master Pro Device

53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 08/25/2017

Desc: Peni Master Pro Device

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 08/25/2017

Desc: Peni Master Pro Device

78 L - - KY Device, External Penile Rigidity
Date Published: 08/25/2017

Desc: Peni Master Pro Device

UAB PROFARMA
Date Published : 10/28/2020
V. A. Graiciuno 6 , Vilnius, Vilnius County LITHUANIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/28/2020

Desc: PRORAPID KIT CORONAVIRUS DISEASE (SARS-COV-2) IGG/IGM RAPID TEST CASSETTE SINGLE USE KIT
Notes: Class III device, requires 510(k), or de novo application

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/28/2020

Desc: PRORAPID KIT CORONAVIRUS DISEASE (SARS-COV-2) IGG/IGM RAPID TEST CASSETTE SINGLE USE KIT
Notes: Class III device, requires 510(k), or de novo application

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/28/2020

Desc: PRORAPID KIT CORONAVIRUS DISEASE (SARS-COV-2) IGG/IGM RAPID TEST CASSETTE SINGLE USE KIT
Notes: Class III device, requires 510(k), or de novo application

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/28/2020

Desc: PRORAPID KIT CORONAVIRUS DISEASE (SARS-COV-2) IGG/IGM RAPID TEST CASSETTE SINGLE USE KIT
Notes: Class III device, requires 510(k), or de novo application


LUXEMBOURG


Biotech Industry
Date Published : 09/16/2009
212 Rue Bernard Haal , Luxemburg, LUXEMBOURG
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 09/16/2009

Notes: New Fill Poly Lactic Implant (Dermal Implant for Aesthetic Use) 4/9/2001


MALAYSIA


AccoBiotech
Date Published : 06/22/2020
Bandar Seri Alam, 81750 , No. 11 Jalan Bukit 27, Masai , Masai, Johor MALAYSIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: ACCO COVID-19 IgM/IgG TEST

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: ACCO COVID-19 IgM/IgG TEST

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: ACCO COVID-19 IgM/IgG TEST

Alang Bidara Industries Sdn Bhd
Date Published : 09/16/2009
Lot 2574 , Kampong Olak Lempit , Banting, Selangor, MALAYSIA
80 F - - MC Glove, Patient Examination
Date Published: 09/16/2009

Notes: Latext patient Examination Gloves

Celestica Electronics (M) Sdn Bhd-(
Date Published : 04/01/2022
Lot 1 , Air Port Logistics Parksenai Intl , Senai, Johor MALAYSIA
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/01/2022

Desc: Pelican COVID-19 Ultra-Rapid Mobile Test for At-Home Testing

GMP Medicare Sdn Bhd(F25)
Date Published : 08/23/2022
Lot/PT 64593, Jalan Dahlia/KU8 , Kawasan Perindustrian Meru Timur , Klang , Selangor MALAYSIA
80 L - - YY Glove, Patient Examination, Latex
Date Published: 08/23/2022

Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black

80 L - - YY Glove, Patient Examination, Latex
Date Published: 08/23/2022

Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 08/23/2022

Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 08/23/2022

Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black

80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs
Date Published: 08/23/2022

Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black

80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs
Date Published: 08/23/2022

Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black

Geocontactlens.Net
Date Published : 09/29/2011
22 Lorong 2a/27c, Seksyen 5 , Wangsa Majuwangsa Maju, MALAYSIA
73 - - - -- Anesthesiology
Date Published: 09/29/2011

Notes: All devices; Class II/III

74 - - - -- Cardiovascular
Date Published: 09/29/2011

Notes: All devices; Class II/III

76 - - - -- Dental
Date Published: 09/29/2011

Notes: All devices; Class II/III

77 - - - -- Ear,Nose And Throat
Date Published: 09/29/2011

Notes: All devices; Class II/III

78 - - - -- Gastroenterological & Urological
Date Published: 09/29/2011

Notes: All devices; Class II/III

79 - - - -- General & Plastic Surgery
Date Published: 09/29/2011

Notes: All devices; Class II/III

80 - - - -- General Hospital/Personal Use
Date Published: 09/29/2011

Notes: All devices; Class II/III

84 - - - -- Neurological
Date Published: 09/29/2011

Notes: All devices; Class II/III

85 - - - -- Obstetrical & Gynecological
Date Published: 09/29/2011

Notes: All devices; Class II/III

86 - - - -- Ophthalmic
Date Published: 09/29/2011

Notes: All devices; Class II/III

87 - - - -- Orthopedic
Date Published: 09/29/2011

Notes: All devices; Class II/III

89 - - - -- Physical Medicine
Date Published: 09/29/2011

Notes: All devices; Class II/III

90 - - - -- Radiology
Date Published: 09/29/2011

Notes: All devices; Class II/III

Maxter Glove Manufacturing Sdn Bhd
Date Published : 03/06/2024
Lot 6070, Jalan Haji Abdul Manan, , 6th Miles Off Jalan, Meru , Klang, Selangor, MALAYSIA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 03/06/2024

Desc: Supermax Nitrile Gloves

Maxvue Vision Sdn Bhd
Date Published : 10/07/2010
614 1 Jalan Haruan 4 8 , Negeri Sembilan, MALAYSIA
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD.
Date Published : 10/21/2020
Revongen Corporation Center, Level 17 , Top Glove Tower , Shah Alam, Selangor MALAYSIA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/21/2020

Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/21/2020

Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/21/2020

Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/21/2020

Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test

Uniqso Holdings Sdn Bhd
Date Published : 02/03/2016
Jalan Balakong Batu , 1/2 , Cheras, Selangor MALAYSIA
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 02/03/2016

Desc: Contact lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 02/03/2016

Desc: Contact lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 02/03/2016

Desc: Contact lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 02/03/2016

Desc: Contact lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 02/03/2016

Desc: Contact lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 01/30/2019

Desc: Contact lenses
Notes: 2/3/2016

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 02/03/2016

Desc: Contact lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 02/03/2016

Desc: Contact lenses

Visco Technology Sdn
Date Published : 02/22/2016
2686 Jalan Todak , Penang, MALAYSIA
86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 02/22/2016

Desc: Monthly Silicone Hydrogel Soft Contact Lenses


MALTA


ORBISAN LTD
Date Published : 05/23/2012
Ub3a Industrial Estate , San Gwann, San Gwann MALTA
78 L - - KY Device, External Penile Rigidity
Date Published: 05/23/2012

Desc: Penis Extender
Notes: Class II

78 N - - HU Extender, Penile, Mechanical
Date Published: 05/23/2012

Desc: Penis Extender
Notes: class II

79 B - - TA Pump, Portable, Aspiration (Manual Or Powered)
Date Published: 05/23/2012

Desc: Penis Extender
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 05/23/2012

Desc: Penis Extender
Notes: class II


MAURITIUS


Esparron Limited
Date Published : 04/02/2014
2nd Floor, Pres John Kennedy St , Port Louis, MAURITIUS
89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 04/02/2014

Desc: Lamp; Infrared; Therapeutic Heating
Notes: class II Manufacturer: Health Technology (Pty) Ltd, FEI #3007843485

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 04/02/2014

Desc: Stimulator; Muscle; Powdered; For Muscle Conditioning
Notes: class II Manufacturer: Health Technology (Pty) Ltd, FEI #3007843485


MEXICO


DRA. Olga Z. de Kleiman
Date Published : 09/16/2009
Calle Cuernavaca 175-101 , Col. Hipodromo Condesa, Cuauhtemoc , Ciudad De Mexico, Ciudad de Mexico MEXICO
73 F - - LS Monitor (Apnea Detector), Ventilatory Effort
Date Published: 09/16/2009

Notes: Little Sentry Junior Monitor 6/29/2000

HSIN TEN ENTERPRISES MEXICO
Date Published : 08/30/2013
Calle Licenciado Jose Benitez 2704 , Col. Obispado, Monterrey , Monterrey, Nuevo Leon MEXICO
89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy
Date Published: 04/23/2021

Desc: Acupuntador
Notes: class II; 8/30/2013

Industrias Manufactureras De Tamaulipas S.A. de C.V.
Date Published : 01/22/2010
Calle Ignacio Zaragoza # 203 , Col. CHINA , China, Nuevo Leon MEXICO
79 E - - RY Drape, Surgical, Ent
Date Published: 01/22/2010

Desc: Thermofleet Blanket
Notes: Class II Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH.

80 K - - ME Bedding, Disposable, Medical
Date Published: 01/22/2010

Desc: Thermofleet Blanket
Notes: Class I Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH.

MAQILADORA TAMAULIPAS S.A. de C.V.
Date Published : 01/22/2010
2 CENTARIO ESQ. Y GUERRERO , Allende 512 , SAN FERNANDO, TAMAULIPAS MEXICO
79 E - - RY Drape, Surgical, Ent
Date Published: 01/22/2010

Desc: Thermofleet Blanket
Notes: Class II Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH.

80 K - - ME Bedding, Disposable, Medical
Date Published: 01/22/2010

Desc: Thermofleet Blanket
Notes: Class I Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH.

RR Donnelley Global Turnkey Solutions
Date Published : 04/04/2022
Blvd Internacional 881 , San Jeronimo, Cd , Juarez, Chihuahua MEXICO
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/04/2022

Desc: Exa SARS- CoV-2 Rapid Antigen Test


MONACO


1-Minute-Test Ltd
Date Published : 09/16/2009
13 Bd Princesse Charlotte , Monte Carlo, MONACO
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: HIV 1/2 Whole Blood Test Kit. 11/9/1999. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIV 1/2 Whole Blood Test Kit. 11/9/1999. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.


NETHERLANDS


Dermatude
Date Published : 11/03/2016
Burgemeesterlaan 2 , Weert, Limburg NETHERLANDS
80 - - - -- General Hospital/Personal Use
Date Published: 11/08/2018

Desc: Meta-Ject FX50

Diagnoptics Technologies B.V.
Date Published : 12/09/2013
L.J. Zielstraweg 1 , Groningen, Groningen NETHERLANDS
74 D - - QK Computer, Diagnostic, Programmable
Date Published: 12/09/2013

Desc: Advanced Glycation Endproduct
Notes: class II

95 R - - GW UV/IR Research Product, General Optical, Non-Medical
Date Published: 12/09/2013

Desc: Advanced Glycation Endproduct
Notes: class II

INNOFAITH BEAUTY SCIENCE
Date Published : 03/11/2024
Science Park Eindhoven , 5204-B, 5692eg , Son, NETHERLANDS
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/11/2024

Desc: OBSERV 520X; 520X BEAUTY TOOL

79 N - - RJ Ultrasound, Skin Permeation
Date Published: 03/11/2024

Desc: OBSERV 520X; 520X BEAUTY TOOL

79 P - - SN Light based imaging
Date Published: 03/11/2024

Desc: OBSERV 520X; 520X BEAUTY TOOL

INZEK INTERNATIONAL TRADING
Date Published : 05/04/2021
Vissenstraat 32 , Apeldoorn, Gelderland NETHERLANDS
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/04/2022

Desc: BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/04/2021

Desc: Biozek COVID-19 Antigen Rapid Test Cassette

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/04/2021

Desc: Biozek Antigen Rapid Test

INZEK INTERNATIONAL TRADING BV
Date Published : 04/04/2022
B. V. Laan Van De Ram 4 , Apeldoorn, NETHERLANDS
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/04/2022

Desc: BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502)

Ortomed B V
Date Published : 06/20/2019
Fruiteniersstraat 23 , Postbus 1081 , Zwijndrecht, Zuid-Holland NETHERLANDS
76 - - - -- Dental
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

77 - - - -- Ear,Nose And Throat
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

87 - - - -- Orthopedic
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

Superstar Bv
Date Published : 08/14/2012
Florijnstraat 12 , Oosterhout, Noord-brabant NETHERLANDS
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 08/14/2012

Desc: Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 08/14/2012

Desc: Contact Lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 08/14/2012

Desc: Contact Lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 08/14/2012

Desc: Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 08/14/2012

Desc: Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 08/14/2012

Desc: Contact Lenses
Notes: class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 08/14/2012

Desc: Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 08/14/2012

Desc: Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 08/14/2012

Desc: Contact Lenses
Notes: class II

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 08/14/2012

Desc: Contact Lenses
Notes: class II


NEW ZEALAND


Honey Collection Ltd
Date Published : 06/13/2018
69 Grove Road , Mayfield , Blenheim , Marlborough NEW ZEALAND
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 06/13/2018

Desc: Manuka Magic Skin Care Cream

79 F - - RO Dressing
Date Published: 06/13/2018

Desc: Manuka Magic Skin Care Cream


PAKISTAN


DAR EXPO
Date Published : 01/23/2019
P.O. Box 356, Fatima Jinnah Road , Sialkot, PAKISTAN
85 H - - FX Clamp, Circumcision
Date Published: 01/23/2019

Desc: Circumcision Clamps
Notes: 5/17/2000

GOGI ENTERPRISES
Date Published : 09/16/2009
Defence Rd., Padana Gloves , P.O. Box 1367 , Sialkot, Punjab PAKISTAN
85 H - - FX Clamp, Circumcision
Date Published: 09/16/2009

Notes: 5/17/2000 Circumcision Clamps.


PHILIPPINES


C WORLD KSG CORPORATION
Date Published : 11/29/2016
NO 2 8th Street Golden Mile Business Par , Cavite, Calabarzon PHILIPPINES
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 11/29/2016

Desc: Contact lens cases
Notes: Class II Device                                                                                                              

86 L - - RX Case, Contact Lens
Date Published: 11/29/2016

Desc: Contact lens cases
Notes: Class II Device                                                                                                            

RICHARD KIM
Date Published : 10/13/2016
The Levels Com , Cavite, Calabarzon PHILIPPINES
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 12/08/2016

Desc: Case; Contact Lens
Notes: Class II Device;                                                                                                                                                                                                                                              ; ***                                                                                                                                                                                                                                                                                                 ***

86 L - - RX Case, Contact Lens
Date Published: 10/13/2016

Desc: Case; Contact Lens
Notes: Class II Device;                                                                                                                                                                                                                                                 ; ***                                                                                                                                                                                                                                                                                                     ***

Richard Kim
Date Published : 12/08/2016
Unit 1206 , The Levels Anaheim Condo , Filinvest City, Muntinlupa City, PHILIPPINES
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 12/08/2016

Desc: Case; Contact Lens
Notes: Class II Device;                                                                                                                                                                                                                                              ; ***                                                                                                                                                                                                                                                                                                ***

86 L - - RX Case, Contact Lens
Date Published: 12/08/2016

Desc: Case; Contact Lens
Notes: Class II Device;                                                                                                                                                                                                                                             ;***                                                                                                                                                                                                                                                                                                 ***


POLAND


Inteliclinic
Date Published : 11/16/2016
Ul. Wladyslawa Niegolewskiego 17 , Warsaw, Mazowieckie POLAND
84 D - - QA Cranial Motion Measurement Device
Date Published: 11/16/2016

Desc: Sleep Mask

84 O - - LZ automatic event detection software for polysomnograph with electroencephalograph
Date Published: 11/16/2016

Desc: Sleep Mask

STERIPACK MEDICAL POLAND SP. Z O. O.
Date Published : 09/30/2021
Ul. Japonska 1 , Jelcz-Laskowice, Dolnoslaskie POLAND
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: BiologyWorks k(now) COVID-19 Molecular Test


RUSSIA


Akvalon Co. Ltd.
Date Published : 07/11/2011
St. Petersburg Sajtseva Str, 41. Lit A. , Russia, RUSSIA
80 L - - DQ Device, General Medical
Date Published: 07/11/2011

Desc: Egyptian Healing Rods
Notes: Class III

Akvalon Co., Ltd
Date Published : 07/11/2011
43 Zajtseva Street , Stpetersburg, RUSSIA
80 L - - DQ Device, General Medical
Date Published: 07/11/2011

Desc: Egyptian Healing Rods
Notes: Class II

Firma Dinamika Llc. Co.
Date Published : 03/31/2013
Parkhomenko 1st Lane 14 , Novosibirsk, RUSSIA
80 N - - ZJ Respirator, n95, home use
Date Published: 03/31/2013

Desc: Fralov's Respiration Training Devices
Notes: Class II

RITM OKB ZAO
Date Published : 02/25/2011
99, PETROVSKAYA , TAGANROG, RUSSIA
84 H - - CC Device, Biofeedback
Date Published: 02/25/2011

Desc: Hair Probe; Healing Blanket; Electrode Belt; Paravertebral Pawns; Cosmetiological Probe
Notes: Class II


SINGAPORE


AIBIOTECH PTE LTD
Date Published : 09/30/2021
25 Pandan Crescent , Tic Tech Centre , Singapore, SINGAPORE
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: abTES%u2122 COVID-19 qPCR Kit

AMT PTE. LTD.
Date Published : 09/30/2021
3 Tuas Lane , Singapore, South West SINGAPORE
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: RESOLUTE 2.0 SARS-CoV-2 Detection Assay

BIOLIDICS LIMITED
Date Published : 07/17/2020
37 Jalan Pemimpin , Mapex207 , Singapore, SINGAPORE
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)

CELL ID PTE LTD
Date Published : 10/28/2020
3 Gambas Crescent , Nordcom One , Singapore, SINGAPORE
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/28/2020

Desc: Smart Covid-19 Igm/IgG RDT
Notes: Class III device, requires 510(k), or de novo application

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: Quiz SARS-CoV-2 NAT System

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/28/2020

Desc: Smart Covid-19 Igm/IgG RDT
Notes: Class III device, requires 510(k), or de novo application

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/28/2020

Desc: Smart Covid-19 Igm/IgG RDT
Notes: Class III device, requires 510(k), or de novo application

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/28/2020

Desc: Smart Covid-19 Igm/IgG RDT
Notes: Class III device, requires 510(k), or de novo application

CREDO DIAGNOSTICS BIOMEDICAL PTE
Date Published : 09/30/2021
1 Fifth Avenue , Guthrie House , Singapore, SINGAPORE
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: VitaPCR Instrument -VitaPCR SARS-CoV-2 Gen 2 Assay

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: VitaPCR SARS-CoV-2 Gen2 External Control Set

Forefront Medical Technology (Pte) Ltd.
Date Published : 09/30/2021
35 Joo Koon Circle , Floor 6th , Singapore, SINGAPORE
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: BioWalker SARS- CoV-2 Assay 2.0

Genelabs Diagnostics Pte Ltd.
Date Published : 09/16/2009
Singapore Science Park , 85 Science Park Drive; #04-01 The Cavendish , Singapore, SINGAPORE
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: OraScreen HIV Rapid Test Kits 8/13/1997 HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

83 L - - YR Campylobacter Pylori
Date Published: 09/16/2009

Notes: Helico Blot 2.0; 8/13/1997

83 - - - -- Microbiology
Date Published: 01/23/2019

Desc: HEV IgM. ELISA
Notes: 8/13/1997

Jal Innovations
Date Published : 10/04/2018
190 Middle Road , Fortune CentreCENTRE , Singapore, SINGAPORE
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 10/04/2018

Desc: iCare HIV 1&2 Rapid Screen Test

57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 10/04/2018

Desc: iCare One-Step HIV 1/2 Oral Fluid Test

57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 10/04/2018

Desc: iCare HIV 1&2 Oral Swab Rapid Screen Test

82 - - - -- Immunology
Date Published: 10/04/2018

Desc: iCare HIV 1&2 Oral Swab Rapid Screen Test

82 - - - -- Immunology
Date Published: 10/04/2018

Desc: iCare HIV 1&2 Rapid Screen Test

82 - - - -- Immunology
Date Published: 10/04/2018

Desc: iCare One-Step HIV 1/2 Oral Fluid Test

83 - - - -- Microbiology
Date Published: 10/04/2018

Desc: iCare One-Step HIV 1/2 Oral Fluid Test

83 - - - -- Microbiology
Date Published: 10/04/2018

Desc: iCare HIV 1&2 Rapid Screen Test

83 - - - -- Microbiology
Date Published: 10/04/2018

Desc: iCare HIV 1&2 Oral Swab Rapid Screen Test

MIRXES PTE LTD
Date Published : 09/30/2021
2 Tukang Innovation Grove , Jtc Medtech Hub #09-02 , Singapore, SINGAPORE
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 06/13/2022

Desc: MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/13/2022

Desc: MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 09/30/2021

Desc: MiRXES Fortitude SARS-CoV-2 & FluA/B Test

Osim International (S) Pte Ltd
Date Published : 09/16/2009
240, Macpherson Road, 07-01 Pines , Singapore, SINGAPORE
74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive
Date Published: 01/30/2019

Desc: Blood Pressure Monitors Massagers Muscle Stimulators
Notes: Class III; 4/29/2005

74 D - - XQ Cuff, Blood-Pressure
Date Published: 01/30/2019

Desc: Blood Pressure Monitors Massagers Muscle Stimulators
Notes: Class III; 4/29/2005

84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 01/30/2019

Desc: Blood Pressure Monitors Massagers Muscle Stimulators
Notes: Class III; 4/29/2005

89 I - - PF Stimulator, Muscle, Powered
Date Published: 01/30/2019

Desc: Blood Pressure Monitors Massagers Muscle Stimulators
Notes: Class III; 4/29/2005

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/30/2019

Desc: Blood Pressure Monitors Massagers Muscle Stimulators
Notes: Class III; 4/29/2005

89 M - - PH Stimulator, Electrical, Muscle
Date Published: 09/16/2009

Notes: Blood Pressure Monitors Massagers Muscle Stimulators; Class III; 4/29/2005

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 01/30/2019

Desc: Blood Pressure Monitors Massagers Muscle Stimulators
Notes: Class III; 4/29/2005

Racer Technology Pte Ltd
Date Published : 05/14/2021
28 Changi South Street 1 , Singapore, SINGAPORE
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: SARS-CoV-2 IgM/IgG Testing Kit

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: SARS-CoV-2 IgM/IgG (GICA) Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: Genabio SARS-CoV-2 IgM/IgG Testing Kit

SENSING SELF PTE LTD
Date Published : 10/28/2020
160 Robinson Road , Singapore Business Federation Center , Singapore, SINGAPORE
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/28/2020

Desc: Covid-19 Rapid IgG/IgM Combined Antibody Assay Pre-Screening Kit
Notes: Class III device, requires 510(k), or de novo application

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/28/2020

Desc: Covid-19 Rapid IgG/IgM Combined Antibody Assay Pre-Screening Kit
Notes: Class III device, requires 510(k), or de novo application

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/28/2020

Desc: Covid-19 Rapid IgG/IgM Combined Antibody Assay Pre-Screening Kit
Notes: Class III device, requires 510(k), or de novo application

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/28/2020

Desc: Covid-19 Rapid IgG/IgM Combined Antibody Assay Pre-Screening Kit
Notes: Class III device, requires 510(k), or de novo application

Vela Operations Singapore Pte Ltd
Date Published : 12/03/2021
50 Science Park Road , #05-07, The Kendall , Singapore, CENTRAL SINGAPORE SINGAPORE
83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 12/03/2021

Desc: ViroKey Flu A/B & RSV RT-PCR Extension Kit (For use with ViroKey SARS-CoV-2 RT-PCR Test v2;0) pin 301073


SOUTH AFRICA


Ageless (M A Meyer)
Date Published : 09/16/2009
Box 29054 , Sunnyside, SOUTH AFRICA
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka HIV/AIDS test kit) 1/29/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka HIV/AIDS test kit) 1/29/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

Anytestkits
Date Published : 09/16/2009
unknown , Sunnyside, SOUTH AFRICA
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: HIV 2 Blood Test Kit 5/25/2000 HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIV 2 Blood Test Kit 5/25/2000 HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

ENVIRON SKIN CARE (PTY) LTD (Prev. Environ Cosmeceutics CC)
Date Published : 07/20/2012
14 Jan Smuts Road , Cape Town, Western Cape SOUTH AFRICA
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS- CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS- CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ;

79 G - - ED Brush, Dermabrasion, Manual
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

79 G - - FD Dermatome
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ;

79 G - - FE Brush, Dermabrasion
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ; ;

79 M - - DM Instrument, Manual, General Surgical
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

79 N - - AB Gauze/Sponge, Nonresorbable For External Use
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ;

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS- CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ; ;

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 12/22/2016

Desc: Environ DF II Sonophoresis & Iontophoresis Facial Machine (Ionzyme DF II)
Notes: Class II device without a valid 510k

89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS- CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ;

Globalemed Sa Pty Ltd
Date Published : 01/23/2019
Unit 9 Montague Square Montague , Garden , Cape Town, SOUTH AFRICA
81 M - - TK Kit, Sample Collection, HIV
Date Published: 01/23/2019

Desc: HIV Test Kit
Notes: Class III; 9/18/2009

81 M - - TL Monitor, Test, HIV-1
Date Published: 01/23/2019

Desc: HIV Test Kit
Notes: Class III; 9/18/2009

81 M - - VZ System, Test, Home, HIV-1
Date Published: 01/23/2019

Desc: HIV Test Kit
Notes: Class III; 9/18/2009

82 M - - TL Monitor, Test, HIV-1
Date Published: 01/23/2019

Desc: HIV Test Kit
Notes: Class III; 9/18/2009

82 M - - VZ System, Test, Home, HIV-1
Date Published: 01/23/2019

Desc: HIV Test Kit
Notes: Class III; 9/18/2009

82 M - - ZF Test, HIV Detection
Date Published: 01/23/2019

Desc: HIV Test Kit
Notes: Class III; 9/18/2009

Health Technology (Pty) Ltd
Date Published : 04/02/2014
Unit 3, 6 Palmfield Road , Springfield Park, SOUTH AFRICA
89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 04/02/2014

Desc: Lamp; Infrared; Therapeutic Heating
Notes: class II Distributor: Esparron Limited, FEI #3008028431

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 04/02/2014

Desc: Stimulator; Muscle; Powdered; For Muscle Conditioning
Notes: class II Distributor: Esparron Limited, FEI #3008028431

ICT INTERNATIONAL
Date Published : 07/17/2020
271 De Goerde , Cape Town, SOUTH AFRICA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 07/17/2020

Desc: 2019-nCoV IgG/IgM Rapid Test Cassette

83 Q - - KO Reagent, coronavirus serological
Date Published: 07/17/2020

Desc: 2019-nCoV IgG/IgM Rapid Test Cassette

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/17/2020

Desc: 2019-nCoV IgG/IgM Rapid Test Cassette

Institute for Vision Improvement
Date Published : 08/15/2022
P.O.Box 7840 , Johannesburg, SOUTH AFRICA
86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 08/15/2022

Desc: Lens; Spectacle; Non-Custom (Prescription)
Notes: No 510K

86 H - - QZ Frame, Spectacle
Date Published: 08/15/2022

Desc: Frame; Spectacle
Notes: No 510K

LIFEASSAY DIAGNOSTICS PTY LTD
Date Published : 06/22/2020
Capricorn Business Technology Pa , Trojan House Gateway CL , Cape Town, SOUTH AFRICA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: COVID-19 IgM/IgG Lateral Flow Assay

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: COVID-19 IgM/IgG Lateral Flow Assay

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: COVID-19 IgM/IgG Lateral Flow Assay

Lifeassay Diagnostics (Pty) Ltd
Date Published : 06/22/2020
Lifeassay House , 7 Bell Crescent , Cape Town, Western Cape SOUTH AFRICA
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/22/2020

Desc: COVID-19 IgM/IgG Lateral Flow Assay

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2020

Desc: COVID-19 IgM/IgG Lateral Flow Assay

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 06/22/2020

Desc: COVID-19 IgM/IgG Lateral Flow Assay

Sallamander Concepts
Date Published : 09/07/2010
DBA Zest for Life , Box 14007 , Hatfield, Gauteng SOUTH AFRICA
75 - - - -- Chemistry
Date Published: 09/07/2010

Desc: Sanitoets Urine test strips
Notes: Class II

82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond
Date Published: 09/07/2010

Desc: Sanitoets Prostate Home test
Notes: Class III

83 O - - AX Plasmodium spp. Detection reagents
Date Published: 09/07/2010

Desc: Sanitoets Malaria home test
Notes: Class II

Sallamander Concepts (Pty) Ltd
Date Published : 09/07/2010
359 Chruch Ave , Lynnwood, SOUTH AFRICA
75 - - - -- Chemistry
Date Published: 09/07/2010

Desc: Sanitoets Urine Test Strips
Notes: Class II

82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond
Date Published: 09/07/2010

Desc: Sanitoets Prostate home test
Notes: Class III

83 O - - AX Plasmodium spp. Detection reagents
Date Published: 09/07/2010

Desc: Sanitoets Malaria Home test
Notes: Class II

Sallamander Concepts CC
Date Published : 09/07/2010
103 Harvest Crescent , Lynnwood Pretoria, Gauteng SOUTH AFRICA
75 - - - -- Chemistry
Date Published: 09/07/2010

Desc: Sanitoets Urine test strips
Notes: Class II

82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond
Date Published: 09/07/2010

Desc: Sanitoets Prostate home Test
Notes: Class III

83 O - - AX Plasmodium spp. Detection reagents
Date Published: 09/07/2010

Desc: Sanitoets Malaria Home test
Notes: Class II

Sallamander Concepts Cc
Date Published : 09/16/2009
Box 29054 , Sunnyside, SOUTH AFRICA
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/16/2009

Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka HIV/AIDS test kit) 1/29/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

75 - - - -- Chemistry
Date Published: 09/07/2010

Desc: Sanitoets Urine Test Strips
Notes: Class II

82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond
Date Published: 09/07/2010

Desc: Sanitoets Prostate Home Test
Notes: Class III

82 - - - -- Immunology
Date Published: 09/16/2009

Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka HIV/AIDS test kit) 1/29/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

83 O - - AX Plasmodium spp. Detection reagents
Date Published: 09/07/2010

Desc: Sanitoets Malaria Home test
Notes: Class II

Sallamander Concepts Pty Ltd
Date Published : 09/07/2010
320 The Hillside Lynwood , Hatfield, SOUTH AFRICA
75 - - - -- Chemistry
Date Published: 09/07/2010

Desc: Sanitoets Urine test strips
Notes: Class II

82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond
Date Published: 09/07/2010

Desc: Sanitoets Prostate home test
Notes: Class III

83 O - - AX Plasmodium spp. Detection reagents
Date Published: 09/07/2010

Desc: Sanitoets Malaria Home test
Notes: Class II

Vivida SA cc
Date Published : 07/20/2012
183 Bree Street , Cape Town, Western Cape SOUTH AFRICA
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

79 G - - ED Brush, Dermabrasion, Manual
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

79 G - - FD Dermatome
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

79 G - - FE Brush, Dermabrasion
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

79 M - - DM Instrument, Manual, General Surgical
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

79 N - - AB Gauze/Sponge, Nonresorbable For External Use
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ;

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 07/20/2012

Desc: Dermabraders or demabrasion devices
Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.


SPAIN


Innovaciones Disras Sl
Date Published : 08/09/2017
Pol. Ind. San Isidro - C/L Los Pedregeles N' 66 , Don Benito, Badajoz SPAIN
79 G - - BI Material, External Aesthetic Restoration
Date Published: 08/09/2017

Desc: OTOSTICK
Notes: 21 CFR 878.3800 (External aesthetic restoration prosthesis) is the most appropriate device classification for this product. The labeling for Otostick states that it is an "ear correction device" for which "some adaptation time may be required" and "correct adaptation without any discomfort will be progressively achieved." The labeling also states "corrects excessive prominence of the ears." The intended use appears to cause structure change to the placement of the ears.

79 H - - XD Clamp
Date Published: 08/09/2017

Desc: OTOSTICK
Notes: 21 CFR 878.3800 (External aesthetic restoration prosthesis) is the most appropriate device classification for this product. The labeling for Otostick states that it is an "ear correction device" for which "some adaptation time may be required" and "correct adaptation without any discomfort will be progressively achieved." The labeling also states "corrects excessive prominence of the ears." The intended use appears to cause structure change to the placement of the ears.

Medicalium Energies & Health
Date Published : 10/08/2019
Calle Pasteur 57 E , Terrassa, Barcelona SPAIN
79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/08/2019

Desc: HR3 Cap
Notes: Class II device without a valid 510(k).

79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite
Date Published: 10/08/2019

Desc: Presojet Pressure Massage
Notes: Class II device without a valid 510(k).


SWEDEN


Hook Of Sweden
Date Published : 07/15/2010
Holmuddsvagen 43 , Gavle, SWEDEN
89 L - - YG Massager, Therapeutic, Manual
Date Published: 07/15/2010

Desc: Hook of Sweden Trigger Point Massager
Notes: Class II

Lic Rehab Care aka LIC Care AB
Date Published : 09/16/2009
Svetsarvagen 20 , 5 17183 Solna or Box 8164 S-163 8 Spanga , Solna, Stockholm SWEDEN
80 F - - NL Bed, Ac-Powered Adjustable Hospital
Date Published: 09/16/2009

Notes: BD50000 OPtima Birthing Bed (10/27/1992) BD6000 Optima Birthing Bed (10/27/1992)

Mareli Medical AB
Date Published : 02/26/2019
Isbergs Gata 18 , Malmo, Skane Lan SWEDEN
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 02/26/2019

Desc: Derma Fillers
Notes: Class III                                                                                                                                                                .

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 02/26/2019

Desc: Derma Fillers
Notes: Class III                                                                                                                                                                .

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 02/26/2019

Desc: Derma Fillers
Notes: Class III                                                                                                                                                                .

53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 02/26/2019

Desc: Derma Fillers
Notes: Class III                                                                                                                                                                .

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 02/26/2019

Desc: Derma Fillers
Notes: Class III                                                                                                                                                                .

62 C - - 04 Clonidine Transdermal Patches
Date Published: 02/26/2019

Desc: Derma Fillers
Notes: Class III                                                                                                                                                                .

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/26/2019

Desc: Derma Fillers
Notes: Class III                                                                                                                                                                .

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 02/26/2019

Desc: Derma Fillers
Notes: Class III                                                                                                                                                                .

79 M - - DD Device, Dermal Replacement
Date Published: 02/26/2019

Desc: Derma Fillers
Notes: Class III                                                                                                                                                                .

87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 02/26/2019

Desc: Derma Fillers
Notes: Class III                                                                                                                                                                .

Orkla Care AB
Date Published : 05/19/2011
Svetsarvagen 15 , Solna, Stockholms Lan SWEDEN
73 C - - BP Valve, Non-Rebreathing
Date Published: 05/19/2011

Desc: Cederroth Breathing Mask
Notes: Class II

Q-Med AB
Date Published : 09/16/2009
Seminariegatan 21 , Uppsala, Uppsala Lan SWEDEN
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 06/04/2019

Desc: Perlane Sodium Hyaluronic Acid
Notes: 6/3/2002

Scandicare Ab
Date Published : 09/16/2009
Box 24 (Agatan 7) , Anderstorp, SWEDEN
79 H - - XD Clamp
Date Published: 09/16/2009

Notes: All devices 11/21/1995 DWI = DE

85 H - - FW Clamp, Umbilical
Date Published: 09/16/2009

Notes: 11/21/1995 All devices DWI = DE.

Tataa Biocenter Ab
Date Published : 01/06/2022
Odinsgatan 28 , Goteborg, Vastra Gotalands Lan SWEDEN
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/06/2022

Desc: GDx GrandPerformance SARS-CoV-2 Detection Kit

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/06/2022

Desc: TATAA GrandPerformance SARS-CoV-2 Detection Kit


SWITZERLAND


BLOOM DIAGNOSTICS AG
Date Published : 01/26/2021
Susenbergstrasse 185 , Zurich, Zurich SWITZERLAND
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: Bloom COVID-19 Test

Bilimed AG
Date Published : 09/16/2009
Ch-5608 , Stetton, SWITZERLAND
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. DWI = DE. Belimed Washing Machine Model SM 700 (3/5/1992) Belimed Scope Washing Machine Model SME 2000 (3/5/1992) Belimed Washington Machine Midel SM 1000 (3/5/1992)

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Connectorate Ag
Date Published : 10/28/2010
Bernstrasse 390 , Dietikon, Zurich SWITZERLAND
76 K - - OK Sterilizer, Endodontic Dry Heat
Date Published: 10/28/2010

Desc: Glass bead sterilizers
Notes: Class III

Corange International Ltd. Hamilton Cham Branch
Date Published : 09/16/2009
Hinterbergstrasse 9 , Postfach 5146 , Cham 1, Zug SWITZERLAND
83 L - - OM Hepatitis B Test (B Core, Be Antigen, Be Antibody, And B Core Igm)
Date Published: 09/16/2009

Notes: Elecsys HBsAg Immunoassay Kits 11/26/1997

DJO GLOBAL SWITZERLAND SARL
Date Published : 09/16/2009
ZI Larges Pieces A , Chemin du Devent , Ecublens, Vaud SWITZERLAND
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 09/16/2009

Notes: Compex 2 Iontophotoresis.

Hamo Ag
Date Published : 09/16/2009
Bielstrasso 76 Ch 2542 , Pieterlen, SWITZERLAND
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI = DE. Endoclean 2000 and Decontaminating Machines Models LS-- 850 LS-76 DW/T-216

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Health Angel GMBH
Date Published : 09/16/2009
Obergass 3 , Eglisau, Zurich SWITZERLAND
84 G - - WF Stimulator, Electrical, Evoked Response
Date Published: 09/16/2009

Notes: Evoked Response Electrical Stimulator 5/25/2001

Home Art And Sales
Date Published : 09/16/2009
Glarnerstrasse 88 , Siebnen, SWITZERLAND
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Zepter Cosmetics Electro-Acupuncture Device 12/3/2003
Notes: 12/3/2003

MDT BIOELECTRONICS
Date Published : 07/21/2017
Bahnhofstrasse 16 , Bettwiesen, Thurgau SWITZERLAND
73 - - - -- Anesthesiology
Date Published: 07/21/2017

Notes: All Devices

74 - - - -- Cardiovascular
Date Published: 07/21/2017

Notes: All Devices

76 - - - -- Dental
Date Published: 07/21/2017

Notes: All Devices

77 - - - -- Ear,Nose And Throat
Date Published: 07/21/2017

Notes: All Devices

78 - - - -- Gastroenterological & Urological
Date Published: 07/21/2017

Notes: All Devices

79 - - - -- General & Plastic Surgery
Date Published: 07/21/2017

Notes: All Devices

80 - - - -- General Hospital/Personal Use
Date Published: 07/21/2017

Notes: All Devices

84 - - - -- Neurological
Date Published: 07/21/2017

Notes: All Devices

85 - - - -- Obstetrical & Gynecological
Date Published: 07/21/2017

Notes: All Devices

86 - - - -- Ophthalmic
Date Published: 07/21/2017

Notes: All Devices

87 - - - -- Orthopedic
Date Published: 07/21/2017

Notes: All Devices

89 - - - -- Physical Medicine
Date Published: 07/21/2017

Notes: All Devices

90 - - - -- Radiology
Date Published: 07/21/2017

Notes: All Devices

Mediatronic S.A.
Date Published : 09/16/2009
route des Jeunes 5C , Les Acacias, Geneva SWITZERLAND
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. GPI=DE. 4/20/2005.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Minimally Invasive Products, GmbH
Date Published : 09/16/2009
Unknown , Kreuzlingen, SWITZERLAND
89 I - - RO Vibrator, Therapeutic
Date Published: 09/16/2009

Notes: Orbasone TM; aka Orbasone Therpeutic Vibrator and Ossanol TM; aka Ossanol Therapeutic Vibrator. 6/29/2000

Nouvag Ag
Date Published : 08/14/2019
St. Gallerstrasse 23-25 , Goldach, St. Gallen SWITZERLAND
79 M - - UU System, Suction, Lipoplasty
Date Published: 08/14/2019

Desc: Liposuction Machine
Notes: Class II device; requires 510(k); or de novo application

PESCHKE TRADE GMBH
Date Published : 04/17/2019
Bosch 67 , Hunenberg, Zug SWITZERLAND
68 - - - -- Animal Devices and Diagnostic Products
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

73 - - - -- Anesthesiology
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

74 - - - -- Cardiovascular
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

76 - - - -- Dental
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

77 - - - -- Ear,Nose And Throat
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

78 - - - -- Gastroenterological & Urological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

79 - - - -- General & Plastic Surgery
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

80 - - - -- General Hospital/Personal Use
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

84 - - - -- Neurological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

85 - - - -- Obstetrical & Gynecological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

86 - - - -- Ophthalmic
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

87 - - - -- Orthopedic
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

89 - - - -- Physical Medicine
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

90 - - - -- Radiology
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

Peschke Meditrade
Date Published : 04/17/2019
Chasigass 6a , Hunenberg, Zug SWITZERLAND
68 - - - -- Animal Devices and Diagnostic Products
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

73 - - - -- Anesthesiology
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

74 - - - -- Cardiovascular
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

76 - - - -- Dental
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

77 - - - -- Ear,Nose And Throat
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

78 - - - -- Gastroenterological & Urological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

79 - - - -- General & Plastic Surgery
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

80 - - - -- General Hospital/Personal Use
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

84 - - - -- Neurological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

85 - - - -- Obstetrical & Gynecological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

86 - - - -- Ophthalmic
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

87 - - - -- Orthopedic
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

89 - - - -- Physical Medicine
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

90 - - - -- Radiology
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

Peschke Meditrade Gmbh
Date Published : 04/17/2019
Zugerstrasse 53 , Cham, SWITZERLAND
68 - - - -- Animal Devices and Diagnostic Products
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

73 - - - -- Anesthesiology
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

74 - - - -- Cardiovascular
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

76 - - - -- Dental
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

77 - - - -- Ear,Nose And Throat
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

78 - - - -- Gastroenterological & Urological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

79 - - - -- General & Plastic Surgery
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

80 - - - -- General Hospital/Personal Use
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

84 - - - -- Neurological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

85 - - - -- Obstetrical & Gynecological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

86 - - - -- Ophthalmic
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

87 - - - -- Orthopedic
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

89 - - - -- Physical Medicine
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

90 - - - -- Radiology
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

Peschke Meritrade Gmbh
Date Published : 10/16/2015
Boesch 6331 , Huenenberg, Zg SWITZERLAND
68 - - - -- Animal Devices and Diagnostic Products
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

73 - - - -- Anesthesiology
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

74 - - - -- Cardiovascular
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

76 - - - -- Dental
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

77 - - - -- Ear,Nose And Throat
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

78 - - - -- Gastroenterological & Urological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/16/2015

Desc: CCL Vario Demo For Trade Show
Notes:                                                                                                                                                                                                                                 

79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/16/2015

Desc: Phoenix Demo for Trade Show
Notes:                                                                                                                                                                                                                                 

79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/16/2015

Desc: CCL 365 Vario Ultraviolet Lamp
Notes:                                                                                                                                                                                                                                 

79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/16/2015

Desc: CCL 365 Corneal Cross-Linking System
Notes:                                                                                                                                                                                                                                 

79 F - - TC Light, Ultraviolet, Dermatological
Date Published: 10/16/2015

Desc: CCL Vario Demo Unit;
Notes:                                                                                                                                                                                                                                 

79 R - - EG Suntan lamp
Date Published: 06/04/2019

Desc: UV Lamp
Notes:                                                                                                                                                                                                                                 ; 10/16/2015

79 - - - -- General & Plastic Surgery
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

80 - - - -- General Hospital/Personal Use
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

84 - - - -- Neurological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

85 - - - -- Obstetrical & Gynecological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

86 H - - RJ Table, Instrument, Powered, Ophthalmic
Date Published: 10/16/2015

Desc: CCL Vario Demo For Trade Show
Notes:                                                                                                                                                                                                                                 

86 H - - RJ Table, Instrument, Powered, Ophthalmic
Date Published: 10/16/2015

Desc: Phoenix Demo for Trade Show
Notes:                                                                                                                                                                                                                                 

86 H - - RJ Table, Instrument, Powered, Ophthalmic
Date Published: 10/16/2015

Desc: CCL Vario Demo Unit
Notes:                                                                                                                                                                                                                                 

86 H - - RJ Table, Instrument, Powered, Ophthalmic
Date Published: 10/16/2015

Desc: CCL 365 Vario Ultraviolet Lamp
Notes:                                                                                                                                                                                                                                   

86 H - - RJ Table, Instrument, Powered, Ophthalmic
Date Published: 10/16/2015

Desc: CCL 365 Corneal Cross-Linking System
Notes:                                                                                                                                                                                                                                 

86 N - - FJ System, Image Management, Ophthalmic
Date Published: 10/16/2015

Desc: CCL Vario Demo For Trade Show
Notes:                                                                                                                                                                                                                                   

86 N - - FJ System, Image Management, Ophthalmic
Date Published: 10/16/2015

Desc: CCL 365 Vario Ultraviolet Lamp
Notes:                                                                                                                                                                                                                                   

86 N - - FJ System, Image Management, Ophthalmic
Date Published: 10/16/2015

Desc: CCL 365 Corneal Cross-Linking System
Notes:                                                                                                                                                                                                                                   

86 N - - FJ System, Image Management, Ophthalmic
Date Published: 10/16/2015

Desc: CCL Vario Demo Unit
Notes:                                                                                                                                                                                                                                   

86 N - - FJ System, Image Management, Ophthalmic
Date Published: 10/16/2015

Desc: Phoenix Demo for Trade Show
Notes:                                                                                                                                                                                                                                   

86 - - - -- Ophthalmic
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

87 - - - -- Orthopedic
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

89 - - - -- Physical Medicine
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

90 - - - -- Radiology
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

95 R - - HW Uv lamp for home or business uses
Date Published: 10/16/2015

Desc: UV Lamp
Notes:                                                                                                                                                                                                                                   

Peschke Trade Gmbh
Date Published : 04/17/2019
Bosch 73 , Hunenberg, Zug SWITZERLAND
68 - - - -- Animal Devices and Diagnostic Products
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

73 - - - -- Anesthesiology
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

74 - - - -- Cardiovascular
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

76 - - - -- Dental
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

77 - - - -- Ear,Nose And Throat
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

78 - - - -- Gastroenterological & Urological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

79 - - - -- General & Plastic Surgery
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

80 - - - -- General Hospital/Personal Use
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

84 - - - -- Neurological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

85 - - - -- Obstetrical & Gynecological
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

86 - - - -- Ophthalmic
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

87 - - - -- Orthopedic
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

89 - - - -- Physical Medicine
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

90 - - - -- Radiology
Date Published: 04/17/2019

Notes: UV Lamp;                                                                                                                                                                                                                                     

Promotus S A
Date Published : 06/20/2019
Route De Divonne 48 , Nyon, SWITZERLAND
76 - - - -- Dental
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

77 - - - -- Ear,Nose And Throat
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

87 - - - -- Orthopedic
Date Published: 06/20/2019

Desc: Implantable Device
Notes: DWPE Date; 4/23/1992

SPRING HEALTHCARE SERVICES AG
Date Published : 05/14/2021
Obstgartenstrasse 5 , Affoltern Am Albis, Zurich SWITZERLAND
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: COVID-19 Rapid IgM/IgG Combined Antibody Assay

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: Spring COVID-19 IgM/IgG Rapid Test Cassette

Storz Medical, AG
Date Published : 04/27/2010
Lohstampfestrasse 8 , Tagerwilen, Thurgau SWITZERLAND
89 O - - OV Evopace system and accessories
Date Published: 04/27/2010

Desc: D-Actor 50 Shockwave device
Notes: Class III

Swisstronics Contract Manufacturing AG
Date Published : 01/26/2021
Gebenloostrasse 15 , Bronschhofen, Saint Gall SWITZERLAND
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/26/2021

Desc: The Bloom Lab

Teoxane S.A.
Date Published : 03/08/2013
Rue De Lyon 105 , Geneva, Geneva SWITZERLAND
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 02/10/2021

Desc: TEOSYAL PureSense Deep Lines
Notes: class II;                                                                                                                                                                                                                       

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 02/10/2021

Desc: TEOSYAL PureSense Ultra Deep
Notes: class II;                                                                                                                                                                                                                       

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 02/10/2021

Desc: TEOSYAL PureSense Global Action
Notes: class II;                                                                                                                                                                                                                       

ZENUM SARL
Date Published : 03/02/2021
Route De La Corniche 3 , Epalinges, Vaud SWITZERLAND
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/25/2021

Desc: SARS-CoV-2 IgG/IgM Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/02/2021

Desc: ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test

83 Q - - LW COVID-19 test home collection kit devices
Date Published: 03/02/2021

Desc: ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test


TAIWAN


ABNOVA TAIWAN CORPORATION
Date Published : 08/31/2021
9th Fl., No.108, Jhouzih St. , Neihu District , Taipei, Taipei TAIWAN
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 08/31/2021

Desc: COVID-19 Viral Antigen Rapid Test

ALLBIO SCIENCE INC
Date Published : 03/02/2021
5F., No. 357, Sec. 3 , Xifeng Road, Northern District , Taichung, TAIWAN
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/02/2021

Desc: COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)

83 Q - - KO Reagent, coronavirus serological
Date Published: 03/02/2021

Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)

Acute Ideas Co., Ltd.
Date Published : 09/16/2009
3F, No.11, Lane 35, Jihu Road, , Taipei, Taipei TAIWAN
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 09/16/2009

Notes: Pacifier Thermometer 3/9/1994

Apoza Enter Co Ltd
Date Published : 09/07/2010
6f No 657 Chung , Taipei Hsien, TAIWAN
80 F - - LE Sterilizer, Steam
Date Published: 09/07/2010

Desc: New Clave Autohouse AD& (Non-Vacuum Type)
Notes: Class II, AD7

BeautiStyle International Corp.
Date Published : 09/16/2009
17 Hu Ja Rd.,1f, Lane 149, Sec 4 , Taipei, TAIWAN
89 I - - RO Vibrator, Therapeutic
Date Published: 09/16/2009

Notes: Ozone Clean and Beauty Massager 4/29/2002                                                                          Trade Name Paci-Temp                                                            Trade Name Lumiscope Baby Therm

Chipper Tech Co
Date Published : 09/16/2009
No 19 Lane 53 Shwanglien Street , Taipei, TAIWAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: Brainwave Synchronizer. 9/9/1994.                                                                                                                                            

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

GENEONE DIAGNOSTIC CO LTD
Date Published : 06/08/2022
Xinyi Dist., Taipei City, 110 Taiwan (R.O.C.) , Rm. 2; 5f., No.51, Sec.2, Keelung Rd , Taipei City, TAIWAN
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: GeneOne COVID-19 Nucleic Acid Diagnostic Kit

General Biologicals
Date Published : 01/22/2016
Hsinchu Science Park, Baoshan Township , No 6 Innovation First Rd , Hsinchu Tai, TAIWAN
83 L - - OM Hepatitis B Test (B Core, Be Antigen, Be Antibody, And B Core Igm)
Date Published: 01/22/2016

Desc: EASE BN-96
Notes: Problem; Class III Device

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/13/2022

Desc: GB SARS-CoV-2 Real-Time RT-PCR

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/16/2021

Desc: GB SARS-CoV-2 Ab ELISA

88 P - - PM General purpose reagent
Date Published: 06/13/2022

Desc: GB SARS-CoV-2 Real-Time RT-PCR

Genereach Biotech Corp
Date Published : 01/21/2022
19 Keyuan 2nd Rd. , Xitun Dist. , Taichung City, TAIWAN
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 01/21/2022

Desc: POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent

Hotery Products Corp
Date Published : 03/18/2015
5th Fl.2 No.26 Wu Chuan 2rd Wu-Ku Ind , Taioei Hsien, TAIWAN
89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/18/2015

Desc: Acupuncture Massager

ICARE DIAGNOSTICS INTERNATIONALCO, LTD
Date Published : 11/24/2021
Zhangshan Rd. , No. 3 Tucheng Dist , New Taipei City, TAIWAN
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva

ICARE DIAGNOSTICS INTERNATIONALCO, LTD
Date Published : 11/24/2021
15 F , Beixin Rd, Sec 3; No 207-3 Xindian Dist , New Taipei City, TAIWAN
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva

Inno Health Technology, Inc.
Date Published : 03/02/2021
8f-2, No. 61, Section 2 , Kung Yi Road , Taichung, Taiwan, TAIWAN
83 Q - - KO Reagent, coronavirus serological
Date Published: 03/02/2021

Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 03/02/2021

Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)

Kenmajor Ent. Co.,
Date Published : 06/13/2012
Sec.5 Sinty , Taipei City, TAIWAN
52 A - - 36 Tumbler, drinking (container w/o handle, w/o stem & w/o foot)(Foodware/Cookware/Table
Date Published: 06/13/2012

Desc: Glass Eye Wash Cup
Notes: Class II

86 L - - XQ Cup, Eye
Date Published: 06/13/2012

Desc: Glass Eye Wash Cup
Notes: Class II

Kung's Medical Instruments Company Ltd
Date Published : 09/16/2009
P O Box 55 1620 , Taipei, TAIWAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All devices. 2/1/1993 LYM-03 Terminator Mini-Electrical Syringe Needle Destroyer.

74 - - - -- Cardiovascular
Date Published: 09/16/2009

76 - - - -- Dental
Date Published: 09/16/2009

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

84 - - - -- Neurological
Date Published: 09/16/2009

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

86 - - - -- Ophthalmic
Date Published: 09/16/2009

87 - - - -- Orthopedic
Date Published: 09/16/2009

89 - - - -- Physical Medicine
Date Published: 09/16/2009

90 - - - -- Radiology
Date Published: 09/16/2009

Labturbo Biotech Corporation
Date Published : 06/08/2022
3f-1 , Taipei, TAIWAN
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: LabTurbo AIO COVID-19 RNA Testing Kit

Mesure Technology Co., Ltd.
Date Published : 07/21/2017
7fl., 86, 88 & 88-1, Sec.1 , Kwang Fu Road, San Chung District , Taipei Hsien, TAIWAN
79 M - - YH System, Non-Coherent Light, Photodynamic Therapy
Date Published: 07/21/2017

Desc: Nasal Relief Pinguin

P & C Electronic Co., Ltd.
Date Published : 06/04/2012
63 Wuhwa Street , Taipei, TAIWAN
79 G - - FD Dermatome
Date Published: 06/04/2012

Desc: M-399 Diamond Peel Dematome; Massager
Notes: Class II

Panion & BF Biotech Inc.
Date Published : 05/28/2021
16 F , 3 Park St.; Nangang Dist. , Taipei City, TAIWAN
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 05/28/2021

Desc: Vstrip COVID-19 Antigen Rapid Test

T A YU CHANC INDUSTRIAL CO LTD
Date Published : 01/30/2019
299 NAN YANG ROAD , SENG YAUN, TAIWAN
86 - - - -- Ophthalmic
Date Published: 01/30/2019

Desc: Sun Eeze (Gtsrite) protective eye wear
Notes: 10/14/1994

TRONLINK TECHNOLOGY CO.,LTD
Date Published : 10/04/2017
No.444 , 2, 3 F.; Jianguo N. Rd. Sec. 1; Zhongshan Dist. , Taipei City, TAIWAN
79 G - - DJ Clamp, Surgical, General & Plastic Surgery
Date Published: 10/04/2017

Desc: Skin tag Removal kit
Notes: Class I device without a valid 510K

TaiDoc Technology Corporation
Date Published : 07/27/2021
Wugu District , B1-7f, No.127, Wugong 2nd Rd. , New Taipei City, TAIWAN
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 07/27/2021

Desc: VTRUST COVID-19 Antigen Rapid Test

Taigen Bioscience Corporation
Date Published : 06/08/2022
No 150, Section 4 , 3 F.; Chengde Road , Shilin District, Taipei - District TAIWAN
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: LabTurbo AIO COVID-19 RNA Testing Kit

Taiwan Creations
Date Published : 03/08/2011
112 Chung Shan Rd , Taipei, TAIWAN
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Alpha-wave Healthtronic; MuscleStimulator and Slimming Device
Notes: Class III

Taiwan Creations Joe L Co Ltd
Date Published : 03/08/2011
P.O.Box 26-233 , Taipei, TAIWAN
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: T.E.N.S. Pro 900 Energy Point Stimulator
Notes: Class III

Taiwan Creations Joe L. Co., Ltd.
Date Published : 03/08/2011
NO. 7, 5 F , Lane 235; Pao-Chiao Road , Shin-Tien City Taipei, TAIWAN
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Alpha-wave Healthtronic; MuscleStimulator and Slimming Device
Notes: Class III

Taiwan Creations Joe L. Co., Ltd.
Date Published : 03/08/2011
NO. 7, 5 F , Lane 235; Pao-Chiao Road , Shin-Tien City Taipei, TAIWAN
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Alpha-wave Healthtronic; MuscleStimulator and Slimming Device
Notes: Class III

Taiwan Creations Joe L. Co., Ltd.
Date Published : 03/08/2011
NO. 7, 5 F , Lane 235; Pao-Chiao Road , Shin-Tien City Taipei, TAIWAN
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Alpha-wave Healthtronic; MuscleStimulator and Slimming Device
Notes: Class III

Taiwan Shining Young Trading Co Ltd
Date Published : 09/16/2009
unknown , Taipei, TAIWAN
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 09/16/2009

Notes: Pacifier Thermometer 3/9/1994. >>> Lumiscope Inc. 400 Raritan Center Pkwy. Edison; NJ 08837 << Trade Name Lumiscope Baby Therm

Tyson Bioresearch Inc.
Date Published : 09/16/2009
Science Based Industrial Park , # 22, 5 F; Kedong 3rd Rd. , Miaoli County, TAIWAN
81 M - - VZ System, Test, Home, HIV-1
Date Published: 01/30/2019

Notes: HIV Test Kits. 2/24/2009. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

82 M - - ZF Test, HIV Detection
Date Published: 09/16/2009

Notes: HIV Test Kits. 2/24/2009. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.

U LAMP TECHNOLOGY LTD.
Date Published : 09/16/2009
NO. 111 LANE 22 SEC 1 , HSIN-JEN ROAD , TAIPING CITY, TAICHUNG HSIEN, TAIWAN
89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 09/16/2009

Notes: PainNOT Infrared Heating PAD 5/12/2009

89 I - - RT Pad, Heating, Powered
Date Published: 09/16/2009

Notes: PainNOT Infrared Heating Pad 5/12/2009

Well-Life Healthcare Limited
Date Published : 08/02/2023
Jhonghe District , No. 168, 6 F; Lide St.; Zhonghe Dist. , New Taipei City, TAIWAN
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/02/2023

Desc: Skeen Patch

84 G - - XY Electrode, Cutaneous
Date Published: 08/02/2023

Desc: Skeen Patch

Wintek Microcircuit Corp
Date Published : 09/16/2009
#51 Cheng Teh Road , Taipei, TAIWAN
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 09/16/2009

Notes: Pacifier Thermometer 3/9/1994.                                                                                 Trade Name Dubby                                                                                            

Yas Healthy Fitness Co., Ltd.
Date Published : 09/16/2009
11 F , Taoyuan Dist. , Taoyuan City, TAIWAN
89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 09/16/2009

Notes: Foot Choice Vibrating Heat Massager w/Infrared Heat 5/12/2009

89 L - - YG Massager, Therapeutic, Manual
Date Published: 09/16/2009

Notes: Foot Choice Vibrating Heat Massager w/Infrared Heat 5/12/2009


THAILAND


Amata Medicare Co., Ltd.
Date Published : 02/07/2023
117/14, 117/33 , Moo 5; Bangphai , Muang Nonthaburi, Nonthaburi THAILAND
80 F - - MF Syringe, Piston
Date Published: 02/07/2023

Desc: Loss of Resistance Syringe (Glass)

Nathan Trading Co., Ltd.
Date Published : 01/12/2023
Moo 12 , 58 Palan Sub-District , Khemarat, Ubon Ratchathani THAILAND
80 F - - MC Glove, Patient Examination
Date Published: 01/12/2023

Desc: Nitrile Examination Glove
Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.

80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 01/12/2023

Desc: Nitrile Examination Glove
Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 01/12/2023

Desc: Nitrile Examination Glove
Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.

80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 01/12/2023

Desc: Nitrile Examination Glove
Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.


TURKEY


CHIL TIBBI MAL SAN TIC
Date Published : 08/31/2021
10028 Sok N 11 , Cigli, Izmir TURKEY
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: CHIL COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/serum/Plasma)

CHIL TIBBI MAL SAN TIC
Date Published : 08/31/2021
10028 Sok N 11 , Cigli, Izmir TURKEY
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/31/2021

Desc: CHIL COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/serum/Plasma)

ERKIM ILAC SANAYI
Date Published : 11/24/2021
Koru Sokak No 2 Zorlu C , Istanbul, TURKEY
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: The ErkimCOVID-19 SARS-CoV-2 iRAMP Diagnostic Kit

ERYIGIT MEDICAL DEVICES
Date Published : 06/08/2022
Ivedik Osb 1453 Cad No , Yenimahalle, TURKEY
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 06/08/2022

Desc: Sentebiolab Senteligo SARS- CoV-2 (COVID-19) Multiplex qPCR Detection Kit

ONCOSEM ONKOLOJIK SISTEMLER SAN.VE TIC. A.S
Date Published : 10/21/2020
Mustafa Kemal Mah. Kolbay Is Merkezi A Blok No:6/8 Cankaya , Ankara, TURKEY
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 10/21/2020

Desc: CRT (COVID-19 RAPID TEST)

83 Q - - KO Reagent, coronavirus serological
Date Published: 10/21/2020

Desc: CRT (COVID-19 RAPID TEST)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 10/21/2020

Desc: CRT (COVID-19 RAPID TEST)

83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices
Date Published: 10/21/2020

Desc: CRT (COVID-19 RAPID TEST)

RTA LABORATUVARLARI BIYOLOJIK Urunler Ilac Ve Makine San Tic A.S.
Date Published : 05/14/2021
Plastikciler Organized Industrial Zone (Geposb) Cumhuriye , Gebze, Kocaeli TURKEY
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: Cirrus COVID-19IgM/IgG Antibody Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: Cirrus Serological IgGand IgM Test

TURKLAB TIBBI MALZEMELER SAN. VE TIC. A.S.
Date Published : 06/22/2022
ITOB 10017 Sokak No: 2 Tekeli - Menderes , IZMIR, TURKEY
83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2022

Desc: Toyo SARS-CoV-2 IgM/IgG Ab Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 06/22/2022

Desc: Info SARS-CoV-2 IgM/IgG Ab Test

Teyzeogullarigida Sanayi Ticaret Ltd.
Date Published : 09/16/2009
Sokak No: 25 , Izmir, TURKEY
84 H - - CC Device, Biofeedback
Date Published: 09/16/2009

Notes: Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/2008.

VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI
Date Published : 09/30/2019
Teknokent Ari 1 Sit. No: 2 5 15 , Sariyer, Sariyer Istanbul TURKEY
75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use
Date Published: 09/30/2019

Desc: Vivoo Test Strips
Notes: Class II device that requires 510(k) clearance


UKRAINE


Consultative & Commercial Center " INVET"
Date Published : 09/16/2009
Ac. Zabolotny Str 35/37 , Odessa, UKRAINE
86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 05/03/2021

Desc: Laser Vision Glasses (Pinhole glasses)
Notes: 02/6/08

86 H - - QZ Frame, Spectacle
Date Published: 05/03/2021

Desc: Laser Vision Glasses (Pinhole glasses)
Notes: 02/6/08

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: ENART a Tens Device 2/6/2008 Claims related to disorders of the Central Nervous System; the Peripheral Nervous Systm; the Respiratory system; ect. as well as dental diseases

Science Production Centre Viatec
Date Published : 01/30/2019
Erevanska Street.31/1 , Kiev, UKRAINE
75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter
Date Published: 01/30/2019

Desc: Arbor Test-Microscope for Regulation of Pregnancy
Notes: 3/16/2001


UNITED KINGDOM


ACRE PHARMA LIMITED
Date Published : 03/02/2023
Unit 5-7 , Tintagel , Walsall, UNITED KINGDOM
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 05/11/2023

Desc: SYNVISC ONE
Notes:                                                                  

87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 03/02/2023

Desc: Euflexxa 1% Sodium Hyaluronate
Notes:                                                                  

ALERT-IT CARE ALARMS
Date Published : 08/01/2019
Merrylees Industrial Estate , Leicester, UNITED KINGDOM
74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Date Published: 08/01/2019

Desc: Pulse Guard Package
Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580

84 P - - OS Physiological signal based seizure monitoring system
Date Published: 08/01/2019

Desc: Pulse Guard Package
Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580

Abby TENS
Date Published : 09/16/2009
46 Cambridge Street , Wolverton , Milton Keynes, UNITED KINGDOM
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 09/16/2009

Notes: Obstetric TENS Unit (Abby TENS) 5/15/2003.

Abingdon Health Ltd.
Date Published : 01/06/2022
National Agri-food Innovation Campus , Sand Hutton , York, North Yorkshire UNITED KINGDOM
83 Q - - KO Reagent, coronavirus serological
Date Published: 01/06/2022

Desc: AbC-19 Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 01/06/2022

Desc: Sona Nanotech COVID-19 LFA

Ally Medical Supplies, Ltd
Date Published : 02/16/2018
20-22 Wenlock Road , London, London, City of UNITED KINGDOM
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 02/16/2018

Desc: Hyaluronic Acid
Notes: Class III;                                                                                                                                                                                                                                                                                      

Aquapac International Limited
Date Published : 04/24/2018
7 Bessemer Park , London, FN UNITED KINGDOM
80 L - - ZG Pump, Infusion, Insulin
Date Published: 04/24/2018

Desc: Insulin Pump Case

Aquapac International Ltd
Date Published : 04/24/2018
250 Millwood Road , London, FN UNITED KINGDOM
80 L - - ZG Pump, Infusion, Insulin
Date Published: 04/24/2018

Desc: Insulin Pump Case

Auto-Compute Trading Ltd
Date Published : 03/08/2011
Southall , Middlesex, England UNITED KINGDOM
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Stimulator Electro-Acupuncture
Notes: Class III

Bedfont Scientific, Ltd.
Date Published : 06/04/2019
Station Road , Maidstone, Kent UNITED KINGDOM
75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use
Date Published: 12/03/2019

Desc: GastroCHECK Gastrolyzer

75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use
Date Published: 06/04/2019

Desc: Flexpulse

75 N - - RH System, Breath Measurement
Date Published: 12/03/2019

Desc: GastroCHECK Gastrolyzer

82 M - - VM Autoantibodies, Endomysial (Tissue Transglutaminase)
Date Published: 12/03/2019

Desc: GastroCHECK Gastrolyzer

89 I - - SA Massager, Therapeutic, Electric
Date Published: 06/04/2019

Desc: Flexpulse

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 06/04/2019

Desc: Flexpulse

BioSure (UK) Limited
Date Published : 05/14/2021
Unit 59 , Hillgrove Business Park; Nazeing Road , Waltham Abbey, Essex UNITED KINGDOM
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: BioSURE COVID-19 IgG Antibody Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: BioSURE COVID-19 Antibody Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: BioSURE COVID-19 Antibody Self Test

Body Clock Health Care Ltd
Date Published : 01/23/2019
108 George Lane , SOUTH WOODFORD , London, UNITED KINGDOM
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 01/23/2019

Desc: TENS Elite; Profile TENS; TENS N Tone; TENS Elite Dual Lead; Lady TENS; 804-OB Obstetric TENS Unit (Abby TENS)
Notes: Class III; 5/15/2003

Body Jewellery Shop Ltd
Date Published : 10/07/2010
Unit 625 Orbital Business Parkdwight , Watfordwatford, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

Body Jewellery Shop Ltd
Date Published : 10/07/2010
The Follypinner Hill Farmpinner Hill , Pinnerpinner, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/07/2010

Desc: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

Bodywise Limited
Date Published : 08/22/2016
Unit 8 , Enterprise Way; ISLE OF WHITE , Cowes, Isle of Wight UNITED KINGDOM
85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible
Date Published: 08/22/2016

Desc: Liquid Silk; Sensual Lubricant

Bretherton Therapy Products
Date Published : 09/16/2009
29 Orchard Road , Sandy, Bedfordshire UNITED KINGDOM
84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 08/25/2023

Desc: Lipodren Muscle Stimulator
Notes: DWPE Date 7/20/2005

87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 08/25/2023

Desc: Lipodren Muscle Stimulator
Notes: DWPE Date 7/20/2005

89 I - - PF Stimulator, Muscle, Powered
Date Published: 08/25/2023

Desc: Lipodren Muscle Stimulator
Notes: DWPE Date 7/20/2005

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 08/25/2023

Desc: Lipodren Muscle Stimulator
Notes: DWPE Date 7/20/2005

CACI International
Date Published : 07/19/2011
C a C I House , Unit 9 Spring Villa Park , Edgware, Middlesex UNITED KINGDOM
79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III

89 I - - SA Massager, Therapeutic, Electric
Date Published: 07/19/2011

Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III

89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 07/19/2011

Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III

97 R - - AL Massager, Ultrasonic Non-Medical Devices
Date Published: 07/19/2011

Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III

CHRONOMICS LTD
Date Published : 09/30/2021
1st James Court , Norwich, UNITED KINGDOM
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: SaliVIR Rapid Multiplex COVID19 vRNA Test

83 Q - - LW COVID-19 test home collection kit devices
Date Published: 09/30/2021

Desc: SaliVIR OME Collection kit

Cyrex Limited
Date Published : 03/18/2013
M5 The Maltings , Stanstead Abbots , Herfordshire, UNITED KINGDOM
78 L - - KY Device, External Penile Rigidity
Date Published: 03/18/2013

Desc: ElectraStim Electro Stimulator
Notes: Class II

84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 03/18/2013

Desc: ElectraStim Electro Stimulator
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/18/2013

Desc: ElectraStim Electro Stimulator
Notes: class II

DNANUDGE
Date Published : 09/30/2021
84 Wood Lane , Translation & Innovation Hub , London, Hmf UNITED KINGDOM
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: CovidNudge

83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 09/30/2021

Desc: DnaNudge CovidNudge COVID-19

Daysoft Ltd
Date Published : 08/01/2011
5 Livingstone Boulevard , Scotland, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 08/01/2011

Desc: Contact Lenses
Notes: Class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 08/01/2011

Desc: Contact Lenses
Notes: Class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 08/01/2011

Desc: Contact Lenses
Notes: Class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 08/01/2011

Desc: Contact Lenses
Notes: Class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 08/01/2011

Desc: Contact Lenses
Notes: Class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 08/01/2011

Desc: Contact Lenses
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 08/01/2011

Desc: Contact Lenses
Notes: Class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 08/01/2011

Desc: Contact Lenses
Notes: Class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 08/01/2011

Desc: Contact Lenses
Notes: Class II

Detectamet Ltd.
Date Published : 04/24/2017
Pockington Industrial Estate , York, UNITED KINGDOM
52 B - - 99 Food Related Item, N.E.C.
Date Published: 04/24/2017

Desc: Blue X-Ray Plaster/Strips (Bandages)

79 K - - GX Tape And Bandage, Adhesive
Date Published: 04/24/2017

Desc: Blue X-Ray Plaster/Strips (Bandages)

80 F - - QM Bandage, Elastic
Date Published: 04/24/2017

Desc: Blue X-Ray Plaster/Strips (Bandages)

Dream eyes
Date Published : 02/01/2019
Unit 4 , Building 2; Marlins Meadow , Watford, UNITED KINGDOM
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 02/01/2019

Desc: Contact Lenses & Decorative Contact Lenses
Notes: Class II Device

Edit Wholesale
Date Published : 10/07/2010
Unit 4 Concord Business Centre , Concord Road Acton , London, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

FCL Health Solutions Ltd
Date Published : 02/16/2018
Hawthorns House , Hawthorns Business Centre; Halfords Lane , Smethwick, West Midlands UNITED KINGDOM
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 02/16/2018

Desc: Hyaluronic Acid
Notes: Class III;                                                                                                                                                                                                                                                                                      

Funky Eyes
Date Published : 10/07/2010
Unit 3 Norman Terracebeechings Way , Alfordalford, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

GAELTEC DEVICES LTD
Date Published : 08/14/2018
Dunvegan Fire Station , Glendale Road , Isle Of Skye, HLD UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 08/14/2018

Notes: All medical devices

74 - - - -- Cardiovascular
Date Published: 08/14/2018

Notes: All medical devices

76 - - - -- Dental
Date Published: 08/14/2018

Notes: All medical devices

77 - - - -- Ear,Nose And Throat
Date Published: 08/14/2018

Notes: All medical devices

78 - - - -- Gastroenterological & Urological
Date Published: 08/14/2018

Notes: All medical devices

79 - - - -- General & Plastic Surgery
Date Published: 08/14/2018

Notes: All medical devices

80 - - - -- General Hospital/Personal Use
Date Published: 08/14/2018

Notes: All medical devices

84 - - - -- Neurological
Date Published: 08/14/2018

Notes: All medical devices

85 - - - -- Obstetrical & Gynecological
Date Published: 08/14/2018

Notes: All medical devices

86 - - - -- Ophthalmic
Date Published: 08/14/2018

Notes: All medical devices

87 - - - -- Orthopedic
Date Published: 08/14/2018

Notes: All medical devices

89 - - - -- Physical Medicine
Date Published: 08/14/2018

Notes: All medical devices

90 - - - -- Radiology
Date Published: 08/14/2018

Notes: All medical devices

GLOBAL ACCESS DIAGNOSTICS
Date Published : 04/01/2022
Bedford Technology Park , Thurleigh, UNITED KINGDOM
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/01/2022

Desc: Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/01/2022

Desc: Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test

Gazmatic International
Date Published : 12/01/2011
Swinboard Rd , Essex, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 12/01/2011

Notes: Massager; Class II

74 - - - -- Cardiovascular
Date Published: 12/01/2011

Notes: Massager; Class II

76 - - - -- Dental
Date Published: 12/01/2011

Notes: Massager; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 12/01/2011

Notes: Massager; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 12/01/2011

Notes: Massager; Class II

79 - - - -- General & Plastic Surgery
Date Published: 12/01/2011

Notes: Massager; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 12/01/2011

Notes: Massager; Class II

84 - - - -- Neurological
Date Published: 12/01/2011

Notes: Massager; Class II

85 - - - -- Obstetrical & Gynecological
Date Published: 12/01/2011

Notes: Massager; Class II

86 - - - -- Ophthalmic
Date Published: 12/01/2011

Notes: Massager; Class II

87 - - - -- Orthopedic
Date Published: 12/01/2011

Notes: Massager; Class II

89 - - - -- Physical Medicine
Date Published: 12/01/2011

Notes: Massager; Class II

90 - - - -- Radiology
Date Published: 12/01/2011

Notes: Massager; Class II

Good Night Snoring
Date Published : 12/22/2014
Po Box 1438 , Surrey, UNITED KINGDOM
76 L - - RK Device, Anti-Snoring
Date Published: 01/30/2019

Desc: Anti Snoring Ring
Notes: 12/22/2014

84 M - - VV Device, Acupressure
Date Published: 12/22/2014

Desc: Anti Snoring Ring

HYRIS LIMITED
Date Published : 11/24/2021
One George Yard , London, UNITED KINGDOM
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid
Date Published: 11/24/2021

Desc: bKIT Virus Finder COVID-19

Ion Magnum
Date Published : 12/01/2011
85 Cavendish St , Ipswich, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 12/01/2011

Notes: Massager; Class II

74 - - - -- Cardiovascular
Date Published: 12/01/2011

Notes: Massager; Class II

76 - - - -- Dental
Date Published: 12/01/2011

Notes: Massager; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 12/01/2011

Notes: Massager; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 12/01/2011

Notes: Massager; Class II

79 - - - -- General & Plastic Surgery
Date Published: 12/01/2011

Notes: Massager; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 12/01/2011

Notes: Massager; Class II

84 - - - -- Neurological
Date Published: 12/01/2011

Notes: Massager; Class II

85 - - - -- Obstetrical & Gynecological
Date Published: 12/01/2011

Notes: Massager; Class II

86 - - - -- Ophthalmic
Date Published: 12/01/2011

Notes: Massager; Class II

87 - - - -- Orthopedic
Date Published: 12/01/2011

Notes: Massager; Class II

89 - - - -- Physical Medicine
Date Published: 12/01/2011

Notes: Massager; Class II

90 - - - -- Radiology
Date Published: 12/01/2011

Notes: Massager; Class II

Ion Magnum Ltd
Date Published : 12/01/2011
Mollison Ave Enfield , London, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 12/01/2011

Notes: Massager; Class II

74 - - - -- Cardiovascular
Date Published: 12/01/2011

Notes: Massager; Class II

76 - - - -- Dental
Date Published: 12/01/2011

Notes: Massager; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 12/01/2011

Notes: Massager; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 12/01/2011

Notes: Massager; Class II

79 - - - -- General & Plastic Surgery
Date Published: 12/01/2011

Notes: Massager; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 12/01/2011

Notes: Massager; Class II

84 - - - -- Neurological
Date Published: 12/01/2011

Notes: Massager; Class II

85 - - - -- Obstetrical & Gynecological
Date Published: 12/01/2011

Notes: Massager; Class II

86 - - - -- Ophthalmic
Date Published: 12/01/2011

Notes: Massager; Class II

87 - - - -- Orthopedic
Date Published: 12/01/2011

Notes: Massager; Class II

89 - - - -- Physical Medicine
Date Published: 12/01/2011

Notes: Massager; Class II

90 - - - -- Radiology
Date Published: 12/01/2011

Notes: Massager; Class II

Ionithermie Limited
Date Published : 12/27/2012
9 - 11 Alma Road , Windsor, UNITED KINGDOM
84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes
Date Published: 12/27/2012

Desc: Ionithermie Machine
Notes: Class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 12/27/2012

Desc: Ionithermie Machine
Notes: Class II

89 I - - RT Pad, Heating, Powered
Date Published: 12/27/2012

Desc: Ionithermie Machine
Notes: Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 12/27/2012

Desc: Ionithermie Machine
Notes: Class II

Ionithermie Limited
Date Published : 12/27/2012
Princess Beatrice House , 57 Victoria Street , Windsor, Berkshire UNITED KINGDOM
84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes
Date Published: 12/27/2012

Desc: Ionithermie Machine
Notes: class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 12/27/2012

Desc: Ionithermie Machine
Notes: class II

89 I - - RT Pad, Heating, Powered
Date Published: 12/27/2012

Desc: Ionithermie Machine
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 12/27/2012

Desc: Ionithermie Machine
Notes: class II

Itinstock Com
Date Published : 12/01/2011
Knowledge House Units 1 1a C , London, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 12/01/2011

Notes: Massager; Class II

74 - - - -- Cardiovascular
Date Published: 12/01/2011

Notes: Massager; Class II

76 - - - -- Dental
Date Published: 12/01/2011

Notes: Massager; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 12/01/2011

Notes: Massager; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 12/01/2011

Notes: Massager; Class II

79 - - - -- General & Plastic Surgery
Date Published: 12/01/2011

Notes: Massager; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 12/01/2011

Notes: Massager; Class II

84 - - - -- Neurological
Date Published: 12/01/2011

Notes: Massager; Class II

85 - - - -- Obstetrical & Gynecological
Date Published: 12/01/2011

Notes: Massager; Class II

86 - - - -- Ophthalmic
Date Published: 12/01/2011

Notes: Massager; Class II

87 - - - -- Orthopedic
Date Published: 12/01/2011

Notes: Massager; Class II

89 - - - -- Physical Medicine
Date Published: 12/01/2011

Notes: Massager; Class II

90 - - - -- Radiology
Date Published: 12/01/2011

Notes: Massager; Class II

Itinstock Com
Date Published : 12/01/2011
Knowledge House Units 1 1a C , London, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 12/01/2011

Notes: Massager; Class II

74 - - - -- Cardiovascular
Date Published: 12/01/2011

Notes: Massager; Class II

76 - - - -- Dental
Date Published: 12/01/2011

Notes: Massager; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 12/01/2011

Notes: Massager; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 12/01/2011

Notes: Massager; Class II

79 - - - -- General & Plastic Surgery
Date Published: 12/01/2011

Notes: Massager; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 12/01/2011

Notes: Massager; Class II

84 - - - -- Neurological
Date Published: 12/01/2011

Notes: Massager; Class II

85 - - - -- Obstetrical & Gynecological
Date Published: 12/01/2011

Notes: Massager; Class II

86 - - - -- Ophthalmic
Date Published: 12/01/2011

Notes: Massager; Class II

87 - - - -- Orthopedic
Date Published: 12/01/2011

Notes: Massager; Class II

89 - - - -- Physical Medicine
Date Published: 12/01/2011

Notes: Massager; Class II

90 - - - -- Radiology
Date Published: 12/01/2011

Notes: Massager; Class II

Kays Electronics Ltd
Date Published : 11/30/2011
85 Cavendish Street , Ipswich, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 11/30/2011

Notes: Massager; Class II

74 - - - -- Cardiovascular
Date Published: 11/30/2011

Notes: Massager; Class II

76 - - - -- Dental
Date Published: 11/30/2011

Notes: Massager; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 11/30/2011

Notes: Massager; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 11/30/2011

Notes: Massager; Class II

79 - - - -- General & Plastic Surgery
Date Published: 11/30/2011

Notes: Massager; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 11/30/2011

Notes: Massager; Class II

84 - - - -- Neurological
Date Published: 11/30/2011

85 - - - -- Obstetrical & Gynecological
Date Published: 11/30/2011

Notes: Massager; Class II

86 - - - -- Ophthalmic
Date Published: 11/30/2011

Notes: Massager; Class II

87 - - - -- Orthopedic
Date Published: 11/30/2011

Notes: Massager; Class II

89 - - - -- Physical Medicine
Date Published: 11/30/2011

Notes: Massager; Class II

90 - - - -- Radiology
Date Published: 11/30/2011

Notes: Massager; Class II

Life Energies Ltd
Date Published : 09/16/2009
The Coach House, The Avenue , Odstock, Wiltshiire, UNITED KINGDOM
84 J - - XK Cranial electrotherapy stimulator to treat depression
Date Published: 01/23/2019

Notes: 3/13/2001 Training Materianls; Introductory Training; Level 1 Training; Level 2 Training; Eliminating Electromagnetic Stress From Your Life. Skenar (Self Controlled-Neuro-Adpative Regulator) The NEW Life-Energies Skenar 97.4

84 - - - -- Neurological
Date Published: 09/16/2009

Notes: 3/13/2001 Pocket Skenar Large Energiser Healing Blanket; Medium Energiser Healing Blanket; Small Energiser Healing Blanket; Cell-O-Matt Kit Computer Cleare

MOLOGIC LTD
Date Published : 05/14/2021
Bedford Technology Park , Bedfordshire, UNITED KINGDOM
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: BioSURE COVID-19 IgG Antibody Rapid Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: BioSURE COVID-19 Antibody Self Test

83 Q - - KO Reagent, coronavirus serological
Date Published: 05/14/2021

Desc: BioSURE COVID-19 Antibody Rapid Test

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/04/2022

Desc: Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/04/2022

Desc: Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test

Mesmereyez
Date Published : 09/15/2013
163 Stoney Stanton Rd , Coventry, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

Micromode Medical Ltd
Date Published : 07/19/2011
9 Spring Villa Park Spring Villa , Edgware, UNITED KINGDOM
79 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 11/08/2018

Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III

89 I - - SA Massager, Therapeutic, Electric
Date Published: 07/19/2011

Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III

89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Date Published: 07/19/2011

Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III

97 R - - AL Massager, Ultrasonic Non-Medical Devices
Date Published: 07/19/2011

Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III

Navsarka ltd
Date Published : 09/15/2013
163 Stoney Stanton Road , Coventry, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 09/15/2013

Desc: Contact lenses
Notes: class II

OMEGA DIAGNOSTICS LTD
Date Published : 04/01/2022
Eden Research Park , Littleport, UNITED KINGDOM
83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/01/2022

Desc: Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT)

83 Q - - KP Coronavirus antigen detection test system.
Date Published: 04/01/2022

Desc: Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test

OPATRA
Date Published : 01/22/2020
Dalton House , 60 Windsor Avenue , London, MRT UNITED KINGDOM
79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 01/22/2020

Desc: Synergy Eye Massager

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 01/22/2020

Desc: Synergy Face Massager

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/22/2020

Desc: Synergy Eye Massager

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/22/2020

Desc: Synergy Face Massager

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 10/19/2023

Desc: Synergy Neck Massager Model BP-1808

89 I - - RO Vibrator, Therapeutic
Date Published: 01/22/2020

Desc: Synergy Eye Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/22/2020

Desc: Synergy Face Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/19/2023

Desc: Synergy Neck Massager Model BP-1808

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/22/2020

Desc: Synergy Eye Massager

OPATRA LIMITED
Date Published : 01/22/2020
Gatwick Road , 447 High Road , London, Hry UNITED KINGDOM
79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 01/22/2020

Desc: Synergy Eye Massager

79 O - - HS Light Based over the counter wrinkle reduction
Date Published: 01/22/2020

Desc: Synergy Face Massager

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/22/2020

Desc: Synergy Face Massager

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 01/22/2020

Desc: Synergy Eye Massager

89 I - - RO Vibrator, Therapeutic
Date Published: 01/22/2020

Desc: Synergy Eye Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/22/2020

Desc: Synergy Eye Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/22/2020

Desc: Synergy Face Massager

One Way Circuits Ltd
Date Published : 12/01/2011
Station Roadlenwade , Norwichnorwich, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 12/01/2011

Notes: Massager; Class II

74 - - - -- Cardiovascular
Date Published: 12/01/2011

Notes: Massager; Class II

76 - - - -- Dental
Date Published: 12/01/2011

Notes: Massager; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 12/01/2011

Notes: Massager; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 12/01/2011

Notes: Massager; Class II

79 - - - -- General & Plastic Surgery
Date Published: 12/01/2011

Notes: Massager; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 12/01/2011

Notes: Massager; Class II

84 - - - -- Neurological
Date Published: 12/01/2011

Notes: Massager; Class II

85 - - - -- Obstetrical & Gynecological
Date Published: 12/01/2011

Notes: Massager; Class II

86 - - - -- Ophthalmic
Date Published: 12/01/2011

Notes: Massager; Class II

87 - - - -- Orthopedic
Date Published: 12/01/2011

Notes: Massager; Class II

89 - - - -- Physical Medicine
Date Published: 12/01/2011

Notes: Massager; Class II

90 - - - -- Radiology
Date Published: 12/01/2011

Notes: Massager; Class II

Optipak Limited
Date Published : 09/16/2009
49-53 York Street , Twickenham, UNITED KINGDOM
86 L - - RX Case, Contact Lens
Date Published: 09/16/2009

Notes: "I clean" antibacterial contact lens soaking case 9/3/2008

Oxford Immunotec
Date Published : 08/30/2021
94c Innovation Drive , Abingdon, Oxfordshire UNITED KINGDOM
83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: T cell ELISPOT test for SARS-CoV-2

83 Q - - KO Reagent, coronavirus serological
Date Published: 08/30/2021

Desc: T-SPOT.COVID

PAVAN TRADING LTD
Date Published : 05/23/2018
24 Englestede Close , Birmingham, UNITED KINGDOM
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 05/23/2018

Desc: Hyaluronic Acid
Notes: Class III                                                                                                                                                                                                                                                                                    .

Pavan Trading Ltd.
Date Published : 05/23/2018
Unit U76a , The Merry Hill Centre , Brierley Hill, West Midlands UNITED KINGDOM
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 05/23/2018

Desc: Hyaluronic Acid
Notes: Class III                                                                                                                                                                                                                                                                                    .

Perfector Skincare Ltd./Arasys Ltd.
Date Published : 12/01/2011
26-32 Oxford Road , HOME LIFE HOUSE; ST. , Bournemouth, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 12/01/2011

Notes: Massager; Class II

74 - - - -- Cardiovascular
Date Published: 12/01/2011

Notes: Massager; Class II

76 - - - -- Dental
Date Published: 12/01/2011

Notes: Massager; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 12/01/2011

Notes: Massager; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 12/01/2011

Notes: Massager; Class II

79 - - - -- General & Plastic Surgery
Date Published: 12/01/2011

Notes: Massager; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 12/01/2011

Notes: Massager; Class II

84 - - - -- Neurological
Date Published: 12/01/2011

Notes: Massager; Class II

85 - - - -- Obstetrical & Gynecological
Date Published: 12/01/2011

Notes: Massager; Class II

86 - - - -- Ophthalmic
Date Published: 12/01/2011

Notes: Massager; Class II

87 - - - -- Orthopedic
Date Published: 12/01/2011

Notes: Massager; Class II

89 - - - -- Physical Medicine
Date Published: 12/01/2011

Notes: Massager; Class II

90 - - - -- Radiology
Date Published: 12/01/2011

Notes: Massager; Class II

Perfector Skincare Ltd./Arasys Ltd.
Date Published : 12/01/2011
26-32 Oxford Road , HOME LIFE HOUSE; ST. , Bournemouth, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 12/01/2011

Notes: Massager; Class II

74 - - - -- Cardiovascular
Date Published: 12/01/2011

Notes: Massager; Class II

76 - - - -- Dental
Date Published: 12/01/2011

Notes: Massager; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 12/01/2011

Notes: Massager; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 12/01/2011

Notes: Massager; Class II

79 - - - -- General & Plastic Surgery
Date Published: 12/01/2011

Notes: Massager; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 12/01/2011

Notes: Massager; Class II

84 - - - -- Neurological
Date Published: 12/01/2011

Notes: Massager; Class II

85 - - - -- Obstetrical & Gynecological
Date Published: 12/01/2011

Notes: Massager; Class II

86 - - - -- Ophthalmic
Date Published: 12/01/2011

Notes: Massager; Class II

87 - - - -- Orthopedic
Date Published: 12/01/2011

Notes: Massager; Class II

89 - - - -- Physical Medicine
Date Published: 12/01/2011

Notes: Massager; Class II

90 - - - -- Radiology
Date Published: 12/01/2011

Notes: Massager; Class II

Pfw Six Works Ltd
Date Published : 11/09/2012
Station Road , Cambridge, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 11/09/2012

Desc: Contact Lenses
Notes: class II

Planet Earth Logis
Date Published : 08/26/2012
184 Horbury Road , Wakefield, West Yorkshire UNITED KINGDOM
78 L - - KY Device, External Penile Rigidity
Date Published: 08/26/2012

Desc: Cock Ring
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 08/26/2012

Desc: Penis Extender
Notes: Class II

85 H - - GX Pump, Breast, Powered
Date Published: 08/26/2012

Desc: Breast Pump
Notes: Class II

85 O - - HH Breast pump kit
Date Published: 08/26/2012

Desc: Breast Pump
Notes: Class II

Planet Earth Logistics
Date Published : 08/26/2012
374 Po Box , Wakefield, UNITED KINGDOM
78 L - - KY Device, External Penile Rigidity
Date Published: 08/26/2012

Desc: Penis Extender
Notes: class II

78 L - - KY Device, External Penile Rigidity
Date Published: 08/26/2012

Desc: Cock Ring
Notes: Class II

85 H - - GX Pump, Breast, Powered
Date Published: 08/26/2012

Desc: Breast Pump
Notes: Class II

85 O - - HH Breast pump kit
Date Published: 08/26/2012

Desc: Breast Pump
Notes: class II

PulseGuard International Ltd
Date Published : 08/01/2019
Unit 1, Crown Yard, Bedgebury Rd , Goudhurst, Kent UNITED KINGDOM
74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Date Published: 08/01/2019

Desc: Pulse Guard Package
Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580

84 P - - OS Physiological signal based seizure monitoring system
Date Published: 08/01/2019

Desc: Pulse Guard Package
Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.1580

Puretone Ltd.
Date Published : 09/16/2009
Unit 9-10 , Henley Business Park; Trident Close , Rochester, Kent UNITED KINGDOM
77 K - - LW Masker, Tinnitis
Date Published: 09/16/2009

Notes: 7/15/2009 Tinnitus Maskers

Remar (Grand Turk) Ltd.
Date Published : 03/08/2011
Southall , Middlesex, England UNITED KINGDOM
84 B - - WK Stimulator, Electro-Acupuncture
Date Published: 11/08/2018

Desc: Stimulator Electro-Acupuncture
Notes: Class III

SMILEGEMS LTD
Date Published : 07/23/2012
1 Wardles Close , GREAT BRINGTON , Northampton, Nth UNITED KINGDOM
76 D - - YH Adhesive, Bracket And Tooth Conditioner, Resin
Date Published: 07/23/2012

Desc: Smilegems Temporary Tooth Jewels
Notes: Class II

Sauflon Pharmaceuticals Limited
Date Published : 09/16/2009
49-53 York Street , MIDDLESEX , Twickenham, UNITED KINGDOM
86 L - - RX Case, Contact Lens
Date Published: 09/16/2009

Notes: "i-clean" antibacterial contact lense soaking case 9/3/2008

Savec Health Systems
Date Published : 09/16/2009
120 Deramore Avenue , Northern Ireland , Belfast, Nir UNITED KINGDOM
73 C - - AW Generator, Oxygen, Portable
Date Published: 09/16/2009

Notes: Omnivir Device Possibly listed as oxygen generator 12/17/2008

Sclera Contact Lenses
Date Published : 11/07/2014
56 Games Road The Gatewaycockfosters , Cockfosterscockfosters, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 11/07/2014

Desc: Contact Lenses
Notes: Class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 11/07/2014

Desc: Contact Lenses
Notes: Class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 11/07/2014

Desc: Contact Lenses
Notes: Class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 11/07/2014

Desc: Contact Lenses
Notes: Class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 11/07/2014

Desc: Contact Lenses
Notes: Class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 11/07/2014

Desc: Contact Lenses
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 11/07/2014

Desc: Contact Lenses
Notes: Class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 11/07/2014

Desc: Contact Lenses
Notes: Class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 11/07/2014

Desc: Contact Lenses
Notes: Class II

Sebl Group
Date Published : 01/24/2018
Trafford House , Platt Fold Street , Leigh, Lancashire UNITED KINGDOM
76 E - - BG Crown And Bridge, Temporary, Resin
Date Published: 01/24/2018

Desc: INSTAsmile Clip/Tooth Cove
Notes: Class II device

76 E - - BG Crown And Bridge, Temporary, Resin
Date Published: 01/24/2018

Desc: INSTAsmile Clip On Venners
Notes: Class II device

76 E - - BI Resin, Denture, Relining, Repairing, Rebasing
Date Published: 01/24/2018

Desc: INSTAsmile Clip On Venners
Notes: Class II device

76 E - - BI Resin, Denture, Relining, Repairing, Rebasing
Date Published: 01/24/2018

Desc: INSTAsmile Clip/Tooth Cove
Notes: Class II device

76 N - - XJ Denture, cosmetic only
Date Published: 01/24/2018

Desc: INSTAsmile Clip On Venners
Notes: Class II device

76 N - - XJ Denture, cosmetic only
Date Published: 01/24/2018

Desc: INSTAsmile Clip/Tooth Cove
Notes: Class II device

T&H Marketing Ltd
Date Published : 12/01/2011
Unit 5 , Ventura Centre; Ventura Place , Poole, Dorset UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 12/01/2011

Notes: Massager; Class II

74 - - - -- Cardiovascular
Date Published: 12/01/2011

Notes: Massager; Class II

76 - - - -- Dental
Date Published: 12/01/2011

Notes: Massager; Class II

77 - - - -- Ear,Nose And Throat
Date Published: 12/01/2011

Notes: Massager; Class II

78 - - - -- Gastroenterological & Urological
Date Published: 12/01/2011

Notes: Massager; Class II

79 - - - -- General & Plastic Surgery
Date Published: 12/01/2011

Notes: Massager; Class II

80 - - - -- General Hospital/Personal Use
Date Published: 12/01/2011

Notes: Massager; Class II

84 - - - -- Neurological
Date Published: 12/01/2011

Notes: Massager; Class II

85 - - - -- Obstetrical & Gynecological
Date Published: 12/01/2011

Notes: Massager; Class II

86 - - - -- Ophthalmic
Date Published: 12/01/2011

Notes: Massager; Class II

87 - - - -- Orthopedic
Date Published: 12/01/2011

Notes: Massager; Class II

89 - - - -- Physical Medicine
Date Published: 12/01/2011

Notes: Massager; Class II

90 - - - -- Radiology
Date Published: 12/01/2011

Notes: Massager; Class II

The Garden Pharmacy
Date Published : 09/16/2009
119 Long Acre , London, UNITED KINGDOM
85 L - - LQ Cap, Cervical, Contraceptive
Date Published: 06/04/2019

Desc: Personal Contraceptive Monitor
Notes: Shipper for Unipath Ltd.; 2/5/2002

UM Products Ltd
Date Published : 04/07/2015
Unit 9a Horrace Waller VC Parade , Shaw Cross Business Park , Dewsbury, UNITED KINGDOM
78 L - - KY Device, External Penile Rigidity
Date Published: 04/07/2015

Desc: Hydromax Penis Pump

78 L - - KY Device, External Penile Rigidity
Date Published: 04/07/2015

Desc: Hercules Penis Pump

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/07/2015

Desc: Hercules Penis Pump

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/07/2015

Desc: Hydromax Penis Pump

Ultramax Products Ltd
Date Published : 06/15/2010
Units 4-6 , Malllard Industrial Park , Wakefield, UNITED KINGDOM
78 L - - KY Device, External Penile Rigidity
Date Published: 06/15/2010

Desc: Penis Pump
Notes: Class III

Unipath Limited
Date Published : 09/16/2009
Stannard Way , Priory Business Park , Bedford, UNITED KINGDOM
85 L - - LQ Cap, Cervical, Contraceptive
Date Published: 01/30/2019

Desc: Personal Contraceptive Monitor
Notes: 2/5/2002

Uv Innovations Ltd
Date Published : 10/14/2011
Exp Ww Bic Unit , Enfield Midd, UNITED KINGDOM
89 B - - XB Exerciser, Powered
Date Published: 10/14/2011

Notes: Ion Magnum IV Body and Face Medical Device (Trade names Ion Genius; Forever Young Arasys Perfector; Ion research; Ion Medica and Ion Magnum); Class II

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 10/14/2011

Notes: Ion Magnum IV Body and Face Medical Device (Trade names Ion Genius; Forever Young Arasys Perfector; Ion research; Ion Medica and Ion Magnum); Class II

Vitalia Health Ltdharleyford
Date Published : 06/08/2010
Harleyford Henley Road , Marlow, UNITED KINGDOM
89 M - - BQ Device, Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing
Date Published: 06/08/2010

Desc: Magnessage Device
Notes: Lacks 510(K)

YORKTEST LABORATORIES LIMITED
Date Published : 04/08/2019
Triune Court , Monks Cross Drive , York, YOR UNITED KINGDOM
75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection
Date Published: 04/08/2019

Desc: Food Intolerance Testing Kits
Notes: Class II device without a valid 501K

Youknowit.Com
Date Published : 10/07/2010
The Follypinner Hill Farmpinner Hill , Pinner Hill Roadpinner Hill Road, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/07/2010

Desc: Color Contact Lenses
Notes: class II


UNITED STATES


ALLY MEDICAL SUPPLIES
Date Published : 02/16/2018
1525 Prospect St Ste 203 , Lakewood, NJ 08701-4662 UNITED STATES
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 02/16/2018

Desc: Hyaluronic Acid
Notes: Class III;                                                                                                                                                                                                                                                                                      

Beautiful Image Llc
Date Published : 03/18/2013
30012 Ivy Glenn Dr Ste 220 , Laguna Niguel, CA 92677-5029 UNITED STATES
79 D - - WG Electrosurgical Device
Date Published: 03/18/2013

Desc: Micro current beautiful Image Facial and Body Sculpting
Notes: class II

79 H - - AM Apparatus, Electrosurgical
Date Published: 03/18/2013

Desc: Micro current beautiful Image Facial and Body Sculpting
Notes: class II

Bio-Energy Services Inc.
Date Published : 09/16/2009
18727 Ventura Blvd , Tarzana, CA 91356-3302 UNITED STATES
84 - - - -- Neurological
Date Published: 09/16/2009

Notes: Importer of Record for PAP-IMI Ion Magnetic Conductor Device Unclassified Industry Code 84. 1/13/2003

Biorage Inc
Date Published : 06/30/2015
9108 Tyler Blvd , Mentor, OH 44060-1881 UNITED STATES
89 L - - YG Massager, Therapeutic, Manual
Date Published: 06/30/2015

Desc: Massager
Notes: Rhino Roller; Class II

Choice Med Healthcare Inc
Date Published : 02/16/2018
9245 Laguna Springs Dr Ste 200 , Elk Grove, CA 95758-7991 UNITED STATES
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 02/16/2018

Desc: Hyaluronic Acid
Notes: Class III;                                                                                                                                                                                                                                                                                      

FAIR CHILL SUPPLIES INC
Date Published : 05/23/2018
9401 E Stockton Blvd Ste 145 , Elk Grove, CA 95624-5051 UNITED STATES
87 M - - OZ Acid, hyaluronic, intraarticular
Date Published: 05/23/2018

Desc: Hyaluronic Acid
Notes: Class III                                                                                                                                                                                                                                                                                    .

Micro Current Technology, Inc.
Date Published : 04/23/2012
2244 1st Ave S , Seattle, WA 98134-1408 UNITED STATES
79 G - - EX Powered laser surgical instruments
Date Published: 04/23/2012

Desc: Bio Hydroderm V2 Microderm Abrasion units
Notes: class II

79 G - - EX Powered laser surgical instruments
Date Published: 04/23/2012

Desc: Bio Synthesis Light activated
Notes: class II

79 G - - EX Powered laser surgical instruments
Date Published: 04/23/2012

Desc: Bio Hydroderm Hydrodermabrasion System
Notes: class II

79 G - - FD Dermatome
Date Published: 04/23/2012

Desc: Bio Synthesis Light activated
Notes: Class II

79 G - - FD Dermatome
Date Published: 04/23/2012

Desc: Bio Hydroderm Hydrodermabrasion System
Notes: Class II

79 G - - FD Dermatome
Date Published: 04/23/2012

Desc: Bio Hydroderm V2 Microderm Abrasion units
Notes: Class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 08/21/2012

Desc: Bt-Micro Dermabrasion Unit
Notes: class II

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 08/21/2012

Desc: Bt-Micro Dermabrasion Unit
Notes: class II

UROMATRIX Medical Systems (A Pos-T-Vac Medical Company)
Date Published : 04/20/2011
4811 Technology Dr , Martinez, GA 30907-2606 UNITED STATES
78 L - - KY Device, External Penile Rigidity
Date Published: 04/20/2011

Desc: Medical Extender Andro Penis Extender
Notes: Class II Lacks 510(K)


VIETNAM


MEDICON COMPANY LIMITED
Date Published : 05/04/2021
Truong An Industrial Park, An Khanh Ward, Hoai Duc District , No. 17, L12a Trung Yen Urban Area, Yen Hoa Ward, Cau Giay District , Hanoi, thanh pho VIETNAM
83 Q - - KO Reagent, coronavirus serological
Date Published: 05/04/2021

Desc: Trueline COVID-19 IgG/IgM Rapid Test