(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
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