Import Alert 89-08

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

Import Alert # 89-08
Published Date: 08/14/2017
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 revisions to this import alert dated 02/16/2016 changes the title of this alert to be more accurate; updates the CDRH Import Branch's phone number; clarifies that CDRH review is necessary for the addition or removal of firms, and their products, from this alert; and provides information about reconditioning for products, subject to this alert. Changes are bracketed by asterisks (***).

Note:
Foreign firms previously subject to detention without physical examination under Import Alert #73-03 are now listed on this alert. FDA believes these devices are Class 3 and need a PMA. Please verify when products make entry.

Devices listed in the Red List for this alert have not been determined substantially equivalent or lack either a 510(k) or a Pre-Market Approval (PMA) for commercial distribution or, alternately, lack an Investigational Device Exemption (IDE).

Guidance:

Districts may detain, without physical sampling and analysis, the indicated products from the manufacturers identified in the Red List for this import alert.

A recommendation for detention without physical examination and background information, including analytical worksheets, ***labeling, package inserts, website information, etc.,*** should be forwarded to DIO, Import Operations and Maintenance Branch. *** DIO will coordinate a review of all recommendations for detention without physical examination with CDRH, Office of Compliance, Imports Branch. ***

*** The importer of record may submit to the FDA a written application (Form FDA 766) requesting authorization to bring a device that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning), or by rendering it other than a device. Districts will refer such applications related to this alert to CDRH, Office of Compliance, Imports Branch, for concurrence.

For more information about reconditioning, please refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9, "9-10 - Reconditioning." The RPM is located at FDA's website: http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179472.htm. ***

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at 301-796-6600.

For questions concerning these types of products or other compliance issues, contact CDRH/OC Imports Branch, ***240-402-4020***, or email: cdrhocimport@fda.hhs.gov .

For questions or issues involving import operations, contact the Division of Import Operations at 301-796-0356, or email fdaimportsinquiry@fda.hhs.gov .

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

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at 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, Office of Compliance, Imports Branch.***

Product Description:

Medical devices (see attachment)

Charge:

For Class III device:

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 appears to be a post 1976 device for which a Section 510(k) application has not been determined substantially equivalent or a 510(k) has not been filed [Misbranding, Section 502(o)]."

OASIS charge code - NO 510(k)

Countries

MULTIPLE COUNTRIES (PODS ONLY)

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

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


ARGENTINA


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

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


ARMENIA


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

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

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

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


AUSTRALIA


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 - - - -- Radiological
Date Published: 09/16/2009

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


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.


BRITISH VIRGIN ISLANDS


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

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.


BULGARIA


BTL Industries Limited Bulgaria
Date Published : 07/30/2010
Peshtersko Shouse Blvd 30 , Plovdiv, Plovdiv BULGARIA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 07/30/2010

Desc:AWT-5000 and AWT-6000; Shockwave devices
Notes:Class III; This firm recently received a Promotion and Advertising Warning Letter for these shockwave devices. FDA believes these devices are Class 3 and need a PMA. Please verify when products make entry.

89 O - - OV Evopace system and accessories
Date Published: 07/30/2010

Desc:AWT-5000 and AWT-6000; Shockwave devices
Notes:Class III; This firm recently received a Promotion and Advertising Warning Letter for these shockwave devices. FDA believes these devices are Class 3 and need a PMA. Please verify when products make entry.


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
87 H - - ST Apparatus, Traction, Non-Powered
Date Published: 07/21/2017

Desc:Chisoft Neck Stretcher

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

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 Drive , Etobicoke, ON 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 - - - -- Radiological
Date Published: 09/16/2009

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

BLS Systems Ltd
Date Published : 01/14/2010
1124 South Service Road West , Oakville, ON CANADA
73 K - - GB Mask, Oxygen, Non-Rebreathing
Date Published: 01/14/2010

Desc:Faceshield with one-way valve and filter
Notes:Class II

73 L - - YM Device, CPR Assist
Date Published: 01/14/2010

Desc:Faceshield with one-way valve and filter
Notes:Class II

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

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

Desc:Injectable Bio-Pulmonic Pulmonic 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
76 L - - YD Stimulator, Electromagnetic Bone Growth for Dental Use
Date Published: 09/16/2009

Notes:Bone Growth Stimulator 10/28/2005

89 L - - OE Stimulator, Invasive Bone Growth
Date Published: 09/16/2009

Notes:Bone Growth Stimulator 10/28/2005

89 L - - OF Stimulator, Bone Growth, Non-Invasive
Date Published: 09/16/2009

Notes:Bone Growth Stimulator. 10/28/2005

Cardston Medical Research
Date Published : 08/15/2014
1718 Edinburgh St , New Westminster, BC CANADA
84 N - - HH 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)
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)
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)
Date Published: 08/15/2014

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

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

Desc:Magnetic Pulser (1Amp Fuse; 110VAC) Device
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: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:Tri-Medica (modes; gem zapper; colloidial silver; blood electrifier)
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: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:Electric massager (part 1 & 2; HIC 9019-1020 & HIC 9010-1020); TDP CP-27IR-Heater Lamp
Notes:Class II

89 N - - HH 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

89 N - - HH device, discharge, electrostatic (for pain relief)
Date Published: 08/15/2014

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

89 N - - HH 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 N - - HH 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

89 N - - HH 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

Comptronics Devices Limited
Date Published : 09/16/2009
9008-51 Avenue , Edmonton, Alberta, CANADA
84 J - - XK Stimulator, Cranial Electrotherapy
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
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

Desc:Stimulator Electro-Acupuncture
Notes:Class III

Datrend Systems Inc
Date Published : 03/20/2012
5355 Parkwood Place , Richmond, BC 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:Vitalift System (Electric Therapeutic Massager)
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 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
176 Bullock Dr #13 , Markham, Ontario CANADA
87 H - - ST Apparatus, Traction, Non-Powered
Date Published: 10/01/2010

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
R.R. 2, Viking , Burnt River, Ontario CANADA
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

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. DWI = 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 - - - -- Radiological
Date Published: 09/16/2009

Globus Media
Date Published : 09/16/2009
9390 PIE IX Blvd. , Montreal, QC CANADA
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

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 - - - -- Radiological
Date Published: 09/16/2009

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

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. DWI = 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 - - - -- Radiological
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. DWI = 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 - - - -- Radiological
Date Published: 09/16/2009

Innovatech Designs
Date Published : 09/29/2009
460 Hampton Court , Dollards Des Ormeaux, PQ , Montreal, 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

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

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

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.

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 - - - -- Radiological
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: 11/28/2011

Desc:Andro Penis Extender

78 - - - -- Gastroenterological & Urological
Date Published: 11/28/2011

Desc:Vimax System
Notes:Class II

Oped Canada Distribution
Date Published : 09/16/2009
344 Townsend Ave , Burlington, ON CANADA
76 L - - YD Stimulator, Electromagnetic Bone Growth for Dental Use
Date Published: 09/16/2009

Notes:The manufacturers website                         and the user manual shipped with the product states the product

89 L - - OE Stimulator, Invasive Bone Growth
Date Published: 09/16/2009

Notes:The manufacturers website                         and the user manual shipped with the product states the product

89 L - - OF Stimulator, Bone Growth, Non-Invasive
Date Published: 09/16/2009

Notes:The manufacturers website                         and the user manual shipped with the product states the product

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)

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 - - - -- Radiological
Date Published: 09/16/2009

Pronto Innovations
Date Published : 03/09/2012
601 Gordon Baker Rd , Toronto, 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

Ropack, Inc.
Date Published : 09/20/2016
10801 Mirabeau St , Anjou, Quebec CANADA
76 L - - FD Saliva, Artifical
Date Published: 09/20/2016

Desc:NeutraSal (Artificial Saliva)

Seville Marketing
Date Published : 09/16/2009
P.O. Box 16047 , 3017 Mountain Highway , North Vancouver, BC 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, Ltd.
Date Published : 09/20/2013
2185 Michelin , Laval, QC 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
Date Published: 09/20/2013

Desc:Lipomax RF
Notes:class II

89 I - - LY Lamp, Infrared
Date Published: 09/20/2013

Desc:Lumicell Wave
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 - - - -- Radiological
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 Solution Inc
Date Published : 10/01/2010
145 Anderson Ave , Markham, Ontario CANADA
87 H - - ST Apparatus, Traction, Non-Powered
Date Published: 10/01/2010

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
87 H - - ST Apparatus, Traction, Non-Powered
Date Published: 10/01/2010

Desc:Neck Comforter
Notes:Class I

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

Desc:Neck Comforter
Notes:Class I

X4 Laboratories, Incorporated
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

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 Street , Vancouver, BC 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

Ycy Health Centre
Date Published : 09/14/2011
9253 Shaughnessy Street St , Vancouvervancouver, 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

Zengar Institute Inc
Date Published : 01/10/2017
545a Boul Grand , L'ile-perrot, QC CANADA
84 H - - CC Device, Biofeedback
Date Published: 01/10/2017

Desc:NeuroOptimal Advanced Brain Training Systems


CHINA


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

Ageless Health Industrial Ltd.
Date Published : 05/12/2014
3F, A1 Bldg, Madongshen Ind. Area , No. 33 Shenbei Road, Sima Village , Changping Town, 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

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 Tongzhou Electronic Sci-Tech Co., Ltd.
Date Published : 06/02/2011
No. 539 Wangjiang West Road , Hefei, CHINA
89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 06/02/2011

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 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 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 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.

BEIJING ADSS DEVELOPMENT CO., LTD.
Date Published : 04/24/2013
Building 36 Jinyuanlu , DAXING ECONOMIC DEVELOPMENT ZONE , Daxingqu, Beijingshi CHINA
79 G - - EX Laser Instrument, Surgical, Powered
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

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

80 L - - DQ Device, General Medical
Date Published: 12/14/2011

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

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

89 N - - ZF Massager, cosmetic, static electricity-emitting
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 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 Laser Instrument, Surgical, Powered
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 Globalipl Development Co.
Date Published : 04/04/2012
A312, KaiChi Bldg., JinFu Rd. No. 2, , DaXing Economic Development Zone , Beijing, CHINA
79 G - - EX Laser Instrument, Surgical, Powered
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 Globalipl Develpoment Co Ltd
Date Published : 11/01/2013
B503 Kai Chi Bldg Jing Fu Rd No2 , DaXing Economic Development Zone , 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 Goldenlaser Development Co.
Date Published : 05/29/2012
Rm A905 Fangqun Gongyusouth 3rd Ring , Beijingbeijing, 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 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

80 L - - DQ Device, General Medical
Date Published: 08/22/2016

Desc:IPL SHR E-Light device

Beijing Shhb Technology Co Limited
Date Published : 09/20/2016
No 485 Zhonghau North Street , Handan City, 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
87 H - - ST Apparatus, Traction, Non-Powered
Date Published: 10/01/2010

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 - - - -- 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 - - - -- Radiological
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.

Biocare Electronics Co., Ltd.
Date Published : 09/16/2009
5/F Taohuaguan High-Tech , Innovation Park , Shenzhen, CHINA
85 L - - QT Doppler Ultrasound For Fetal Evaluation
Date Published: 09/16/2009

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

85 L - - XE Fetal Doppler Ultrasound
Date Published: 09/16/2009

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

85 M - - AA Monitor, Fetal Doppler Ultrasound
Date Published: 09/16/2009

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

90 L - - QT Doppler Ultrasound for Fetal Evaluation
Date Published: 09/16/2009

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

90 L - - XE Doppler, Fetal, Ultrasound
Date Published: 09/16/2009

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

90 M - - AA Monitor, Fetal Doppler Ultrasound
Date Published: 09/16/2009

Notes:BU-908 Electronic Convex Ultrasound Scanner. 12/8/2004.

Chang Zhou Kakoo Tea Food Stuff
Date Published : 03/19/2012
Xin Chang Rd 168-08 , Chang Zhou, CHINA
31 K - - 02 Tea, Green
Date Published: 03/19/2012

Desc:Green Tea
Notes:China

Changzhou Kakoo Tea Foodstuff Cp Ltd
Date Published : 03/19/2012
Weishu Beigang , Changzhou, CHINA
31 K - - 02 Tea, Green
Date Published: 03/19/2012

Desc:Green Tea
Notes:china

China National Agricultural Machinery
Date Published : 09/16/2009
unknown , unknown , Shenzhen, 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 - - - -- Radiological
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 - - - -- Radiological
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

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

89 N - - ZF Massager, cosmetic, static electricity-emitting
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

Creata (Shenzhen) Ltd
Date Published : 01/20/2012
5015 Shennan Road 19f Benyuan Bl , Shenzhen, CHINA
80 L - - DQ Device, General Medical
Date Published: 01/20/2012

Desc:Ultra Power LED Light Device
Notes:class II

89 I - - LY Lamp, Infrared
Date Published: 07/13/2012

Desc:Pimple Remover
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 : 03/27/2015
¿¿¿ No. 50 Longquanbei Road , Dajiahe Town, Ning Hai, 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

DONG TIAN YANG INDUSTRIAL CO., LTD
Date Published : 08/10/2016
Dachong Industrial District , Lishui Town , 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

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

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

74 L - - OS System, ECG Analysis,
Date Published: 07/20/2012

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

80 L - - DQ Device, General Medical
Date Published: 07/20/2012

Desc:Electro-acupuncture Machine Unclassified/(Sub-Health Diagnosis Require PMA Therapy Device)

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 City Meizhi Wiring Co., LTD.
Date Published : 08/08/2011
Mange Zone, Dongguan City, Tiantoujiao , Qiaotou Town , Dongguan, CHINA
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

84 M - - IO Light, Therapy, SAD (Seasonal Affective Disorder)
Date Published: 08/08/2011

Desc:Color Ray Beauty Light Therapy Device
Notes:Class II

84 N - - ZY Light, lymphadema reduction, low energy
Date Published: 08/08/2011

Desc:Color Ray Beauty Light Therapy Device
Notes:Class II

E-M Medical Treatment And Electron (Suzhou) Co Ltd
Date Published : 09/09/2014
# 18 Chun Qiu Road , 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:                                                                                                                                                                                                                                            ***

Electronic Instrument Factory
Date Published : 03/08/2011
Unknown Street , Beijing Haidian District, Donghua CHINA
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

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, 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).

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

79 G - - FE Brush, Dermabrasion
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

Foshan Nanhai Newface Beauty Instrument Factory
Date Published : 05/24/2016
Lishui Town , Xiang Gang Hu Tou Wei Hai Bian; Nanhai , Foshan City, Guangdong CHINA
89 L - - YG Massager, Therapeutic, Manual
Date Published: 05/24/2016

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.

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

79 G - - FE Brush, Dermabrasion
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

Fuangzhou Balstar Machinery Co
Date Published : 11/28/2011
Bldg Guangdong Shop T4163b 4fl A , Tianjian, CHINA
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

89 N - - ZF Massager, cosmetic, static electricity-emitting
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.

GENIUS CHIP (SHEN ZHEN) LIMITED
Date Published : 01/17/2013
A303,XUEFU ROAD, ZHONGRUN BUILDING , 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

GUANGZHOU RUIMEI TECHNOLOGY CO. LTD.
Date Published : 07/11/2011
ROOM 1019, HENGSHENG BUILDING B, HUANSHI , ZHONG ROAD NO. 25, YUEXIU DISTRICT , GUANGZHOU, CHINA
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 04/05/2013

Desc:Facial Beauty 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-08XLTB; 5.1 in 1 Mult-Function 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

79 G - - FE Brush, Dermabrasion
Date Published: 07/11/2011

Desc:SYL-08XLT; 4 IN 1 Diamond Dermabrasion System
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 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

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-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-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-08XLT; 4 IN 1 Diamond Dermabrasion System
Notes:Class II

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-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

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-60 (NV-60); Diamond Dermabrasion Machine
Notes:Class II

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:Class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 07/11/2011

Desc:SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine
Notes:Class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 07/11/2011

Desc:SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine
Notes:Class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 07/11/2011

Desc:SYL-60 (NV-60); Diamond Dermabrasion Machine
Notes:Class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 07/11/2011

Desc:SYL-08XLT; 4 IN 1 Diamond Dermabrasion System
Notes:Class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 07/11/2011

Desc:SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine
Notes:Class II

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 - - XZ Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene
Date Published: 09/16/2009

Notes:Pulse Generator; Pacemaker. 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

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 Beco Electronic
Date Published : 10/30/2013
113 South Huadi Ave , Guangzhou, CHINA
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

89 N - - ZF Massager, cosmetic, static electricity-emitting
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
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 12/21/2010

Desc:Massage Ultrasound Equipment
Notes:Class III

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 12/21/2010

Desc:Therapeutic Skin Ultrasound Devices
Notes:Class III

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
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

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

Guangzhou Cnsipot Co., Ltd
Date Published : 06/25/2015
C204-205, Hetai Plastic Materail Agora , Hetai Road, Baiyun District , Guangzhou, 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 Health And Medical Equipment Co Ltd
Date Published : 10/17/2013
1000 Xingang East Road , Guangzhou, 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 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
6 Floor 1 Building No. 14 Zhi Cun Indust , 2 Road Dashi Street, Panyu , Guangzhou City, 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 - - - -- Radiological
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 West Guangyuan Road , Meibo City, Guangzhou 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 Minsheng Electronic Technical Co., Ltd.
Date Published : 11/03/2016
No. 8 Fenghe Street , Renhe Town, Baiyun District , 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
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 L - - DQ Device, General Medical
Date Published: 06/23/2010

Desc:Detoxification Food Spa

Guangzhou Wadami Beauty Equipment Co Ltd
Date Published : 10/03/2013
330 Guang Cong Yi Road, Baiyun Dist , Guangzhou, 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 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
1-3 F, G#, Haan Bian Industrial Zone , 128#, Dong Huan Road, Pan Yu District , Guangzhou, 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
N. 23, 1st Floor, Mid Building, , TianfengPlaza #133-141 Baiyn Avenue No , Guangzhou, 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 - - - -- Radiological
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

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

Hangzhou Ausia Biological Techni
Date Published : 02/03/2012
1# No 1 Street Hanzhou Ecomic An , Hangzhou, CHINA
82 M - - ZF Test, HIV Detection
Date Published: 02/03/2012

Desc:HIV test kit
Notes:class II

Hangzhou Singclean Medical Products Co Ltd
Date Published : 04/28/2017
No 125 (E) 10th Street, Hangzhoui , Economic & Technological Development Zon , 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: 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: 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 Care Massage Branch of Zhangzhou Easepal Ind Co, Ltd.
Date Published : 03/19/2014
Bldg. 1 F 1-5 , 228 Jiaosong Road; Taiwanese Inv. Zone , Zhangzhou, Fujian CHINA
73 K - - FZ Humidifier, Non-Direct Patient Interface (Home-Use)
Date Published: 03/19/2014

Desc:Oxysonic Eye Spa

89 I - - RT Pad, Heating, Powered
Date Published: 03/19/2014

Desc:Oxysonic Eye Spa

89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/19/2014

Desc:Oxysonic Eye Spa

97 R - - AL Massager, Ultrasonic Non-Medical Devices
Date Published: 03/19/2014

Desc:Oxysonic Eye Spa

97 R - - AM Humidifier, Ultrasonic Non-Medical Devices
Date Published: 03/19/2014

Desc:Oxysonic Eye Spa

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

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

89 N - - ZF Massager, cosmetic, static electricity-emitting
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

80 L - - DQ Device, General Medical
Date Published: 12/14/2011

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

89 N - - ZF Massager, cosmetic, static electricity-emitting
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 Canwin Li Health Products
Date Published : 04/20/2016
2nd Floor , Chuangyujindidatechnology , Shenzhen, CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 04/20/2016

Desc:PowerUp Penis Pump

Hongkong Phenitech Co Ltd
Date Published : 04/07/2013
2709 West Tower 12069 Shenan Rd , Shenzhen, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/07/2013

Desc:Digital Therapy Machine Tens Unit
Notes:Class II

Hsin Ten Health and Wealth Industry (HEFEI) Co., Ltd.
Date Published : 09/16/2009
669 Changjiang West Road , Heifei, CHINA
89 I - - LY Lamp, Infrared
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

INTCO MEDICAL HK CO LTD
Date Published : 03/10/2017
3RD FLOOR BUILDING 9 NO , AN RD , SHANGHAI, CHINA
79 F - - XX Mask, Surgical
Date Published: 03/10/2017

Desc:Face Mask
Notes:Device Classification is unknown.

Intec Products, Inc. (Xiamen)
Date Published : 05/12/2014
332 Xinguang Rd., , Xin Yang Industrial Area , Haicang, Xiamen, Fujian Prov., CHINA
81 M - - TK Kit, Sample Collection, HIV
Date Published: 05/12/2014

Desc:HIV Home Test Kit
Notes:Class III

Jian Peng Zhou
Date Published : 06/11/2015
16-2-601 Luxing , Jining, 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
77 L - - RK Device, Anti-Snoring
Date Published: 03/07/2016

Desc:Snore Strip

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

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

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
Qian Wang Tuan Industry Park Chengyang , Qingdao, 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

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

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

Lucky Beauty Equipment Co., LTD.
Date Published : 01/17/2014
Room 2508, huaqiao build, , 1# Daqiao north road , Nanjing, CHINA
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:Lipolaser Machine
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:Lbs12 Vertical RF
Notes:class II

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:Lbs54 lipo Laser Fat Burning
Notes:Class II

79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 01/17/2014

Desc:Lipolaser Machine
Notes:Class II

79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 01/17/2014

Desc:Lbs12 Vertical RF
Notes:class II

79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 01/17/2014

Desc:Panda B; RF Beauty
Notes:Class II

79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 01/17/2014

Desc:LBS11 RF Skin Lift
Notes:Class II

79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 01/17/2014

Desc:Lbs54 lipo Laser Fat Burning
Notes:Class II

79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 01/17/2014

Desc:Lbs56 Lipolaser
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:Panda B; RF Beauty
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:Lipolaser Machine
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:Lbs12 Vertical RF
Notes:class II

89 I - - LY Lamp, Infrared
Date Published: 01/17/2014

Desc:Lbs12 Vertical RF
Notes:class II

89 I - - LY Lamp, Infrared
Date Published: 01/17/2014

Desc:Lbs54 lipo Laser Fat Burning
Notes:Class II

89 I - - LY Lamp, Infrared
Date Published: 01/17/2014

Desc:Panda B; RF Beauty
Notes:Class II

89 I - - LY Lamp, Infrared
Date Published: 01/17/2014

Desc:LBS11 RF Skin Lift
Notes:Class II

89 I - - LY Lamp, Infrared
Date Published: 01/17/2014

Desc:Lipolaser Machine
Notes:Class II

89 I - - LY Lamp, Infrared
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: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: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:Lbs56 Lipolaser
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:Lipolaser Machine
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: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:Lbs12 Vertical RF
Notes:class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/17/2014

Desc:Lipolaser Machine
Notes:Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 01/17/2014

Desc:Lbs56 Lipolaser
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
79 F - - XX Mask, Surgical
Date Published: 08/30/2013

Desc:Surgical Mask
Notes:Class II

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
Huanshi 205 Qilinzhonglu , Yanzhoushi, Yandongsheng 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

Mychway Co. Ltd.
Date Published : 05/05/2013
Room 1701, Pengdu Building , Nanguang Road 126, , Shenzhen, Guangdong, CHINA
79 G - - FE Brush, Dermabrasion
Date Published: 05/05/2013

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

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 05/05/2013

Desc:Laser Lipolysis Device
Notes:class II

Mychway Company
Date Published : 05/18/2015
F 406 4 , NO 6 Bldg Zhongxing Indus , Shenzhen, CHINA
79 G - - EX Laser Instrument, Surgical, Powered
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

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:Facial Brush and Vacuum
Notes:Class II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/20/2010

Desc:Vaporizer
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:Cosmetic Vibrator
Notes:Class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/20/2010

Desc:Massage Hammer
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

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 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

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

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
4/F Zone A, Lingnan Square, 19-Yingbin St , Panyu District , Guangzhou, CHINA
76 E - - HD Unit, X-Ray, Extraoral With Timer
Date Published: 08/07/2017

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

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

80 L - - DQ Device, General Medical
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 Dong Feng Xi Road , Guangzhou, 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: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

80 L - - DQ Device, General Medical
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.

Pioway Medical Lab Equipment Co. Ltd.
Date Published : 03/10/2014
Rm 615a Xinwanli Bldg No. 9 Aixia Rd , Nanjing, CHINA
85 L - - QT Doppler Ultrasound For Fetal Evaluation
Date Published: 03/10/2014

Desc:Digital Ultrasound Scanner
Notes:Class II

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)

REIA MEDTECH XIAMEN, INC.
Date Published : 03/01/2011
1776 LV Ling Road , Xiamen, 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

RELA MEDTECH XIAMEN, INC
Date Published : 03/01/2011
1776 LV LING ROAD , Xiamen, 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

Race Beauty Equipment Co., Ltd.
Date Published : 09/14/2012
No23 Fenghuang 4 Rd , Jiulong Industrial Park , Guangzhou City, CHINA
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

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 09/14/2012

Desc:Biolift Beauty Machine
Notes:class II

Re Chan Industry Co Ltd
Date Published : 09/02/2011
3f Bldg A1 Fuqiao 6th Ind Park Fuyong , Shenzhen, CHINA
89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/02/2011

Desc:Magic Masseuse (Electronic Stimulation Massage unit)
Notes:Class II

SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
Date Published : 03/09/2012
Building A 3 , NO 388 Yindoulu; Xuhui , Shanghai, Shanghai CHINA
79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 03/09/2012

Desc:Intense Pulsed Light (IPL) Systems

79 O - - NF Powered light based non-laser surgical instrument with thermal effect
Date Published: 01/28/2014

Desc:Intense Pulsed Light (IPL) System
Notes:class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 03/09/2012

Desc:Intense Pulsed Light (IPL) Systems

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

SHENZEN JUMEIFENG TECHNOLOGY CO., LTD.
Date Published : 11/16/2016
28 Xingnong Road , Shenzhen City, Guangdong CHINA
79 M - - DM Instrument, Manual, General Surgical
Date Published: 11/16/2016

Desc:Electric Microneedle Derma Pen System

79 M - - DM Instrument, Manual, General Surgical
Date Published: 11/16/2016

Desc:Microneedle Face Roller System

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/16/2016

Desc:Microneedle Face Roller System

80 M - - QX Needle, Acupuncture, Single Use
Date Published: 11/16/2016

Desc:Electric Microneedle Derma Pen System

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

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/18/2014

Desc:Massager
Notes:Class II

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 04/18/2014

Desc:Massager
Notes:Class II

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)

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.

Salon Art Company Limited
Date Published : 04/08/2015
7 D 22 Royalpark Plaza Helong Road First , Guangzhou, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/08/2015

Desc:Air Pressure Body Slimming Suit
Notes:Class II device

Shandong Medicines & Health Products Import /Export Corp.
Date Published : 09/16/2009
16 Baoding Road , Box 42 , Qingdao, 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.

Shanghai Angel Electronic Equipment Co., Ltd.
Date Published : 12/14/2015
Bldg. 5 F 4 , NO. 1135 Baotoulu , Shanghai City, Shanghaishi 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

80 L - - DQ Device, General Medical
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 INTCO Medical Supply Co., Ltd.
Date Published : 03/10/2017
1358 Hubin Lu , Fengxian , Shanghai, Shanghai CHINA
79 F - - XX Mask, Surgical
Date Published: 03/10/2017

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 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

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 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

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: 09/16/2009

Notes:7/20/2005. BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator.

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes:7/20/2005. BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator.

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 09/16/2009

Notes:7/20/2005. BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator.

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes:7/20/2005. BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator.

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: 09/16/2009

Notes:11/8/2007 Ultrasound Scanner

85 L - - QT Doppler Ultrasound For Fetal Evaluation
Date Published: 09/16/2009

Notes:11/8/2007 Ultrasound Scanner

85 L - - XE Fetal Doppler Ultrasound
Date Published: 09/16/2009

Notes:11/8/2007 Ultrasound Scanner

85 M - - AA Monitor, Fetal Doppler Ultrasound
Date Published: 09/16/2009

Notes:11/8/2007 Ultrasound Scanner

90 L - - QT Doppler Ultrasound for Fetal Evaluation
Date Published: 09/16/2009

Notes:11/8/2007 Ultrasound Scanner

90 L - - XE Doppler, Fetal, Ultrasound
Date Published: 09/16/2009

Notes:11/8/2007 Ultrasound Scanner

90 M - - AA Monitor, Fetal Doppler Ultrasound
Date Published: 09/16/2009

Notes:11/8/2007 Ultrasound Scanner

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 Breo Technology Co., Ltd
Date Published : 02/13/2013
Daqing Building Room 13RS , Che Kung Temple, Futian , Shenzhen, Guangdong CHINA
84 M - - VV Device, Acupressure
Date Published: 03/18/2016

Desc:ISee108 Eye Massager

84 M - - VV Device, Acupressure
Date Published: 04/01/2016

Desc:IDream3 Eye and Head Massager

89 I - - RO Vibrator, Therapeutic
Date Published: 02/13/2013

Desc:iComfort Eye-Z Eye and Temple Massager
Notes:class II

89 I - - RO Vibrator, Therapeutic
Date Published: 02/13/2013

Desc:uCrown Pro Head
Notes:class II

89 I - - RO Vibrator, Therapeutic
Date Published: 12/16/2015

Desc:iSee4 massager

89 I - - RO Vibrator, Therapeutic
Date Published: 04/01/2016

Desc:IDream3 Eye and Head Massager

89 I - - RT Pad, Heating, Powered
Date Published: 12/16/2015

Desc:iSee4 massager

89 I - - RT Pad, Heating, Powered
Date Published: 04/01/2016

Desc:IDream3 Eye and Head Massager

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 - - 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: 03/18/2016

Desc:ISee108 Eye 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: 12/16/2015

Desc:iSee4 massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/01/2016

Desc:IDream3 Eye and Head Massager

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 L - - DQ Device, General Medical
Date Published: 03/07/2016

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 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

74 L - - OS System, ECG Analysis,
Date Published: 07/20/2012

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

80 L - - DQ Device, General Medical
Date Published: 07/20/2012

Desc:Electro-acupuncture Machine Unclassified (Sub-Health Diagnosis Require PMA Therapy Device)

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

Desc:Iriscope (Iriscopio)
Notes:Class II

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 Kanger Technology Co Lt
Date Published : 09/16/2009
4th Bldg, 3rd Industrial Zone , Shajing Town Shenzhen, CHINA
66 B - - 44 Nicotine Delivery System
Date Published: 09/16/2009

Notes:Electronic Cigarettes and Components 7/9/2009

66 B - - 99 Stimulant N.E.C.
Date Published: 09/16/2009

Notes:Electronic Cigarettes and Components 7/9/2009

77 E - - PN Pump, Nebulizer, Manual
Date Published: 09/16/2009

Notes:Electronic Cigarettes and Components 7/9/2009

77 K - - CO Inhaler, Nasal
Date Published: 09/16/2009

Notes:Electronic Cigarettes and Components 7/9/2009

89 M - - ZX Stimulator, Electrical for smoking cessation
Date Published: 09/16/2009

Notes:Electronic Cigarettes and Components 7/9/2009

91 D - - LC Atomizer, Tlc
Date Published: 09/16/2009

Notes:Electronic Cigarettes and Components 7/9/2009

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
No.25, 1st Industry Zone, Fenghuang Road , Xikeng Village, Henggang Town, Longgang , 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 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 , XINSHENG,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 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
Bldg 3 , Longhua New District , Shenzhen City, 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

Shijiazhuang Star Plastic Co., Ltd
Date Published : 11/03/2010
Rm101, Unit 3, #38 Building, Rose Garden , #88 Huaian West Rd. , Shijiazhuang, CHINA
80 F - - MC Glove, Patient Examination
Date Published: 11/03/2010

Desc:Synthetic Exam Gloves
Notes:class II

80 L - - YY Glove, Patient Examination, Latex
Date Published: 11/03/2010

Desc:Synthetic Exam Gloves
Notes:class II

80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 11/03/2010

Desc:Synthetic Exam Gloves
Notes:class II

80 L - - ZA Glove, Patient Examination, Poly
Date Published: 11/03/2010

Desc:Synthetic Exam Gloves
Notes:class II

80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 11/03/2010

Desc:Synthetic Exam Gloves
Notes:class II

80 N - - PC Glove, Patient Examination, Powder Free,
Date Published: 11/03/2010

Desc:Synthetic Exam Gloves
Notes:class II

Stareast Beauty & Health Mfg
Date Published : 08/01/2011
No 9 Bixi Road Daliang , Guangdong, CHINA
79 G - - EX Laser Instrument, Surgical, Powered
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 , Miaogao Town , Suichang City 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
2f ,No.14 Jialuo Road,Lane 1661 , Shanghaishanghai, CHINA
79 G - - EX Laser Instrument, Surgical, Powered
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.

Surefine Ningbo Medcare Co Ltd
Date Published : 09/16/2009
168 Baizhang Road , Ningbo, CHINA
80 F - - MC Glove, Patient Examination
Date Published: 09/16/2009

Notes:Patient Examination Gloves 9/23/2005

80 L - - YY Glove, Patient Examination, Latex
Date Published: 09/16/2009

Notes:Patient Examination Gloves 9/23/2005

80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 09/16/2009

Notes:Patient Examination Gloves 9/23/2005

80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 09/16/2009

Notes:Patient Examination Gloves 9/23/2005

Suzhou Armocon Technology Co.Ltd
Date Published : 12/10/2012
3F No.77 Suhong Middle Road, SIP , Jiangsu, CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 05/22/2014

Desc:Penis Ring
Notes:Class II; 12/10/12

Suzhou Medical Appliance Factory
Date Published : 03/21/2017
No.18, Huatuo Road , SSTT 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

Tang Shuwei Dongti
Date Published : 09/16/2009
102 Xiatangxincun , 54 # Lujing Xilu Yuexiuqu , Guangzhou City, 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 & Technology Co., Ltd
Date Published : 04/07/2017
D-18 Huigu Science Nd Technology Park , Tianjin, CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 04/07/2017

Desc:Detox Foot Pads (Luminositie)

Tianjin Fuqin Science And Technology Co Ltd
Date Published : 04/07/2017
Tower Ab Xinmao Science Rm. E7 F 5 , Huayuan Industry Zone , Nankai, Tianjin CHINA
79 K - - GX Tape And Bandage, Adhesive
Date Published: 04/07/2017

Desc:Detox Foot Pads (Luminositie)

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
Industry Development Area, , 107 Country Road, West, Shihling Town , Hua-du City Guangdong, 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 Glasses
Notes:Class II

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 05/22/2012

Desc:Pinhole Sunglasses
Notes:Class II

WUHAN GUANGDUN TECHNOLOGY CO LTD
Date Published : 08/04/2017
3F, 303 OPTICAL VALLEY AVENUE , WUHAN, CHINA
79 G - - EX Laser Instrument, Surgical, Powered
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

89 O - - NH Powered laser non-themal instrument with non-heating effect for adjunctive use in path therapy
Date Published: 08/04/2017

Desc:Medical Laser
Notes:Class II

WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
Date Published : 09/02/2014
NO. 35 Baiqiao Rd. , Xishan District , Wuxi, CHINA
80 M - - QX Needle, Acupuncture, Single Use
Date Published: 07/07/2016

Desc:7 Star Needles
Notes:Only the firm?s 7 Star Needles are subject to dwpe under this alert- their other acupuncture needles are not subject to this IA. Verify the needles are the 7 Star Needles prior to dwpe. The device may be described as 7 Star Acupuncture Needles; 7 Star Dermal Needles; or Seven-Stars Needles.

Wei Cia Ma Kang Co Ltd
Date Published : 01/17/2014
Wang Yu Jie , Wei Cia, CHINA
79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 01/17/2014

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

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 01/17/2014

Desc:Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles
Notes:class II

Weifang Huamei Electronics Co Ltd
Date Published : 06/28/2011
454# Yuanfei Rd Kuiwen Distweifang , Wei Fangwei Fang, 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
2656 Tongyin Street, Gaoxin District , Weifang, 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

89 I - - SA Massager, Therapeutic, Electric
Date Published: 03/08/2013

Desc:Massager
Notes:Class II

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 11/02/2011

Desc:Ultrasound Beauty Machine
Notes:Class; II

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
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

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 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 Industrial Zone , Shenzhen, CHINA
79 G - - FE Brush, Dermabrasion
Date Published: 10/14/2015

Desc:Dermaroller
Notes:class II

Wuhan Gigaa Optronics Technology Co., Ltd.
Date Published : 10/08/2013
High Tech Medicall Park Building B8, Un , # 818 Gaoxin Road , Wuhan, Hubei CHINA
79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 10/08/2013

Desc:Medical Diode Laser

95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 10/08/2013

Desc:Medical Diode Laser

Xiamen Electronic Instrument Plant
Date Published : 03/08/2011
Unknown , Fujian, CHINA
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

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

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
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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 07/13/2012

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

Yall Store
Date Published : 07/13/2012
(N3p)Yue Ao Pu Hua Technology Parkda , 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 - - - -- Radiological
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 - - - -- Radiological
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
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.

89 N - - ZF Massager, cosmetic, static electricity-emitting
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.

ZHANGJIAGANG FULULAI RUBBER-PLASTIC CO., LTD.
Date Published : 10/09/2015
FENGHUANG TOWN , ZHANGJIAGANG, Jiangsu CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 10/09/2015

Desc:Black Lightning Powder Free Nitrile Gloves pH 5.5 (sizes M; L; XL; XXL)
Notes:Class I

ZHONGSHAN QUANDE ELECTRIC FACTORY
Date Published : 07/11/2011
TANBEI INDUSTRIAL ZONE , TANBEL YUANXING ROAD, DONGSHENG , Zhongshan, CHINA
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 08/17/2015

Desc:Electric Acupuncture Pen
Notes:Class II

79 G - - EX Laser Instrument, Surgical, Powered
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

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 Lu , Hangzhou, Zhejiang CHINA
89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 06/02/2011

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

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 - - - -- Radiological
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

Zhuhai Haishen Import Export Co. Ltd
Date Published : 07/21/2017
161 Summer Beauty Rd , Zhuhai, Guangdong CHINA
87 H - - ST Apparatus, Traction, Non-Powered
Date Published: 07/21/2017

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


CZECH REPUBLIC


Ela Moravia
Date Published : 06/23/2011
18 Polanka , Trebic, CZECH REPUBLIC
80 D - - WL Stocking, Medical Support
Date Published: 06/23/2011

Desc:Medical Support Stockings
Notes:Class II

WAKE SPOL. S.R.O.
Date Published : 11/14/2011
ARBESOVA 797/3 , ROKYCANY, 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 , Praha 10, CZ-NOTA 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

Danamedic Aps
Date Published : 09/16/2009
Bostamose Oesterstraede 1a , Klampenborg, 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

Sorribesonline.Com
Date Published : 03/28/2012
Jyllingehoej 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 L - - DQ Device, General Medical
Date Published: 01/21/2014

Desc:Saltarium Salt Cocoon
Notes:Class II

SkandiaLife Manufacturing
Date Published : 09/29/2009
Varbola kula, Marjamaa vald , Raplamaa, ESTONIA
89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 09/29/2009

Desc:Sybaritic Inc. (Sybaritic) Hydration Station
Notes:Class II


FINLAND


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


FRANCE


Burnet Laboratoire Pharmaceutique
Date Published : 09/16/2009
El Medico Chirurgical , 56 Avenue De La Republique , La Ferte Bernard, FRANCE
79 K - - GO Surgeon's Gloves
Date Published: 09/16/2009

Notes:Sterile Surgical Gloves.

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

LARS
Date Published : 09/16/2009
5 Rue de La Fontaine , Arc Surtille , Arc Sur Tille, FRANCE
87 L - - ML Ligaments And Tendons, Synthetic
Date Published: 09/16/2009

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

Laboratoire Nycomed Ingenor Sa
Date Published : 09/16/2009
25, Quai De La Gare - C.E. No. 19 , Paris Cedex, 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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 09/16/2009

Orthomed
Date Published : 09/16/2009
256 Rue Vignes Dardelain , Marsannay La Cote, 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 S.A.S
Date Published : 09/16/2009
Parc d'affaires NOVEOS , 4, avenue Reaumur , Clamart, 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
89 H - - TM Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
Date Published: 09/16/2009

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


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

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.

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

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 - - - -- Radiological
Date Published: 03/13/2013

Notes:All Devices;class I/II/III

Demask Dortmund
Date Published : 03/01/2011
Hamburger Str 120 , 44135 Dortmund , Dortmund, Nordrhein-westfalen 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

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

Instrumed Gmbh
Date Published : 08/28/2014
Unter Buchsteig 3 , Tuttlingen, GERMANY
74 D - - RC Trocar
Date Published: 08/28/2014

Desc:Thoracic Trocar
Notes:Class 2

74 D - - WP Dilator, Vessel, Surgical
Date Published: 08/28/2014

Desc:Vascular Dialators
Notes:Class 2

74 D - - WP Dilator, Vessel, Surgical
Date Published: 08/28/2014

Desc:Vascular Tunnelers
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; 12mm; 8 teeth; tapered (Item# VM NL180)
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: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:Hudson Burr 14mm; (Item# VM NL2SO)
Notes:Class 2

85 H - - DC Tenaculum, Uterine
Date Published: 08/28/2014

Desc:Uterine Tenaculum Forceps
Notes:Class 2

85 H - - DC Tenaculum, Uterine
Date Published: 08/28/2014

Desc:Uterine Tenaculum Hook
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

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 >>> Leibinger L.P. 14540 Beltwood Parkway East Dallas, Texas 75244 <<<

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 - - - -- Radiological
Date Published: 09/16/2009

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 365 Vario Ultraviolet Lamp;
Notes:                                                                                                                                                                                                                                  

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 365 Corneal Cross-Linking System
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 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 Vario Demo Unit
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 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 Vario Ultraviolet Lamp
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 Corneal Cross-Linking System
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:                                                                                                                                                                                                                                  

95 R - - EG Suntan Lamp, Sunlamp Products (Certified), Non-Medical
Date Published: 10/16/2015

Desc:UV Lamp
Notes:                                                                                                                                                                                                                                

95 R - - EG Suntan Lamp, Sunlamp Products (Certified), Non-Medical
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 for Animal Use
Notes:                                                                                                                                                                                                                                  

95 R - - HW Uv lamp for home or business uses
Date Published: 10/16/2015

Desc:UV Lamp
Notes:                                                                                                                                                                                                                                  

Morcher Gmbh
Date Published : 09/16/2009
Kapuzinerweg 12 , Stuttgart, GERMANY
86 H - - QL Lens, Intraocular
Date Published: 09/16/2009

Notes:Aniridia Implant Devices (Modified Intraocular Lenses)2/9/2004

86 M - - RJ Ring, Endocapsular
Date Published: 09/16/2009

Desc:modified intracular lenses or capsular tension rings) 5/31/2001
Notes:Aniridia Implant (ie

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

80 L - - DQ Device, General Medical
Date Published: 04/24/2017

Desc:Microneedling device
Notes:Class II

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 - - - -- Radiological
Date Published: 09/16/2009

Nu Life Enterprise Ltd. & Co.
Date Published : 09/16/2009
Atrikastr 2 , Hohenkirchen Siegertsbrunn, 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-w¿rttemberg 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 Guard (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 Plug (surgical mesh)
Notes:Class II device without 510k

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:TiSURE (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 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 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 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 Strip (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 Guard Set (surgical mesh)
Notes:Class II device without 510k

Pero-System Mebgerate Gmbh
Date Published : 05/17/2016
Lise-Meitner-Str 1-9 , Wuppertal, 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 - - - -- Radiological
Date Published: 09/16/2009

Rayonex Biomedical Gmbh
Date Published : 07/13/2016
Sauerland-Pyramiden 1 , Lennestadt, Nordrhein-westfalen GERMANY
68 X - - 20 Device/Diag Prod For Animal Used More Than 1 Species
Date Published: 07/13/2016

Desc:Fabric Detector

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)
Date Published: 07/13/2016

Desc:Fabric Detector

84 N - - HH Device, Discharge, Electrostatic (for Pain Relief)
Date Published: 07/13/2016

Desc:RAYOCOMP PS 10

Reimers & Janssen Gmbh
Date Published : 08/30/2013
22 Fabrikstrasse , Waldkirch, Baden-w¿rttemberg GERMANY
68 X - - 20 Device/Diag Prod For Animal Used More Than 1 Species
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).

68 X - - 99 Other Animal, N.E.C. Device/Diag Prod For Animal
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).

89 I - - LY Lamp, Infrared
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).

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)

Reimers & Janssen Gmbh
Date Published : 10/11/2013
Reichenbergerstrasse 147 , Berlin, Berlin GERMANY
89 I - - LY Lamp, Infrared
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)

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)

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 - - - -- Radiological
Date Published: 09/16/2009

Sorin Group Deutschland GmbH
Date Published : 01/15/2016
Lindberghstr. 25 , Munich, Bavaria GERMANY
74 D - - WC Controller, Temperature, Cardiopulmonary Bypass
Date Published: 01/15/2016

Desc:Cardiopulmonary Bypass Temperature Controller
Notes:                                                                                                                                                                                             

74 D - - WJ System, Thermal Regulating
Date Published: 01/15/2016

Desc:Thermal Regulating System
Notes:                                                                                                                                                                                               

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 - - - -- Radiological
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
89 M - - OZ Acid, Hyaluronic, Intraarticular
Date Published: 09/16/2009

Notes:Synvisc Hylan Syringe Kits. (Product has European label which contains indications for use not yet approved in the United States) 6/20/2006.

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


HONG KONG


A & A Worldwide C/O Jp
Date Published : 11/28/2011
Room E 11/F West, Aidi Buildingbinhe , Hong Konghong Kong, HONG KONG
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

89 N - - ZF Massager, cosmetic, static electricity-emitting
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
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: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

80 L - - DQ Device, General Medical
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
89 - - - -- Physical Medicine
Date Published: 08/01/2011

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

Asia Pacific Beauty Group Ltd
Date Published : 03/16/2012
Carnarvon Pl 15fl-20 Carnarvon , Tsimshatsui Kowloon, FN HONG KONG
79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 03/16/2012

Desc:Bio-Synthesis Light activated facial rejuvenation system
Notes:Class II

79 G - - EX Laser Instrument, Surgical, Powered
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

79 G - - FD Dermatome
Date Published: 04/23/2012

Desc:Bio Hydroderm Hydrodermabrasion System
Notes:Class II

79 G - - FD Dermatome
Date Published: 04/04/2012

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

Asia Unlimited
Date Published : 09/16/2009
Unknown , Hong Kong, HONG KONG
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 2706 , Mega Trade Centre; 1 Mei Wan St. , Tsuen Wan, New Territories HONG KONG
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 206 Blk B Hi Tech Ind Ctr491-501 , Tsuen Wantsuen Wan, HONG KONG
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
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 - - - -- Radiological
Date Published: 09/16/2009

Azad International (HK) Ltd
Date Published : 09/16/2009
33 Canton Road , TRW 1 Room 2103 , Kowloon, HONG KONG
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).

Bestview St Limited
Date Published : 10/27/2011
610 Nathan Road Rm 1318-19 Hollywood , Kowloon, HONG KONG
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

Bleosense Technology Co Ltd
Date Published : 05/29/2015
33 Mong Kok Road , Kowloon, HONG KONG
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
89 I - - OB Lamp, Infrared, Physical Medicine
Date Published: 09/16/2009

Notes:Hothouse FIR Health Builder 11/26/2001

Create Eyewear
Date Published : 12/06/2010
Unit 206, Block B491-501 Castle Peak , Tsuen Wantsuen Wan, HONG KONG
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

Creative Concepts Manufacturing Ltd
Date Published : 03/11/2015
Suite F2,3rd Floor,Hang Fung , Kowloon, HONG KONG
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

E Concept Technology Co Ltd
Date Published : 05/11/2015
Floor 33 Laws Comm Plaza 788 Cheung Sha , Cheung Sha Wancheung Sha Wan, HONG KONG
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/11/2015

Desc:Portable High Frequency LZ-006A

80 L - - DQ Device, General Medical
Date Published: 05/11/2015

Desc:Portable High Frequency LZ-006A

E-Y Laboratories, (H.K.) Ltd.
Date Published : 09/16/2009
1/F, 23 Mei Wan Street , Tsuen Wan, N.T., HONG KONG
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.

Foshan Nanhai Newface Beauty Instruments
Date Published : 01/09/2013
G/F Fat Lee Ind Bldg , Tai Road , Kowloon Bay, Kwun Tong HONG KONG
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 01/09/2013

Desc:Facial Beauty Machine
Notes:class II

89 L - - OF Stimulator, Bone Growth, Non-Invasive
Date Published: 01/09/2013

Desc:Facial Beauty Machine
Notes:Class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 01/09/2013

Desc:Facial Beauty Machine
Notes:Class II

90 L - - MC Camera, Multi Format, radiological
Date Published: 01/09/2013

Desc:Facial Beauty Machine
Notes:class II

Foshan Nanhai Xin Cheng Hardware
Date Published : 04/05/2013
G/F Fat Lee Ind Bldg Tai Road,Kowloon , Kwun Tongkwun Tong, HONG KONG
79 G - - ED Brush, Dermabrasion, Manual
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

79 G - - FE Brush, Dermabrasion
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

89 N - - ZF Massager, cosmetic, static electricity-emitting
Date Published: 04/05/2013

Desc:Facial Beauty Machine
Notes:class II

Free Flying International Ltd
Date Published : 04/18/2014
5/F Bldg 11 Tongfuyu Industrial Zon E , Kwai Chungkwai Chung, HONG KONG
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

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/18/2014

Desc:Massager
Notes:Class II

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 04/18/2014

Desc:Massager
Notes:Class II

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
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 - - - -- Radiological
Date Published: 07/13/2012

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

HK Aosom International Trading Co. Ltd.
Date Published : 03/25/2016
RM 19C LOCKHART CTR , 301-307 LOCKHART RD , WAN CHAI, HONG KONG
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.

Mayu Technology Group Co., Ltd.
Date Published : 11/13/2012
Unit 2401a, 24/f., Park-in Comm. Ctr. , 56 Dundas St., , Mongkok, HONG KONG
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
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

Promis Asla Hk
Date Published : 07/20/2012
Shop 62a Nd Floor Mirrador Mansion , Kowloon, HONG KONG
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 - - - -- Radiological
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
79 M - - WZ Expander, Breast, External
Date Published: 04/18/2017

Desc:Breast Massager

89 I - - LY Lamp, Infrared
Date Published: 04/18/2017

Desc:Breast Massager

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/18/2017

Desc:Breast Massager

Soft Lines
Date Published : 09/16/2009
1 Science Museum Rd , East Kowloon, HONG KONG
74 M - - NW Analyzer, Body Composition
Date Published: 09/16/2009

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
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.

Tega Industrial Company Ltd.
Date Published : 10/20/2010
Room 1202 Tower 2 Harbour Centre8 Hok , Hong Kong, HONG KONG
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
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
80 M - - QX Needle, Acupuncture, Single Use
Date Published: 12/11/2013

Desc:Micro Needle Skin Roller
Notes:class II

YI Shing Co., Ltd.
Date Published : 09/16/2009
Flat 102-3, 1/F, Tung Chai Building , 86-90 Wellington Street , Hong Kong, HONG KONG
76 K - - KO Ring, Teething, Fluid-Filled
Date Published: 09/16/2009

Notes:cool Ring Teether (Ring; Teething; Fluid-Filled) 2/9/2006

Zero Plus International Limited
Date Published : 07/11/2011
71 75 Container Port Rd , ROOM 1004, 10/F JOIN IN HANG SING CENTRE , Kwai Chung, HONG KONG HONG KONG
79 G - - EX Laser Instrument, Surgical, Powered
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


Eclosion KFT.
Date Published : 09/16/2009
Kalvaria Ter. 2 , Budapest, HUNGARY
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.

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.


INDIA


Aegis Lifesciences
Date Published : 03/10/2014
215/216 Mahagujrat Industrial , Phase III, Changodar, Moraiy , Ahmedabad, 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

HEALTH CARE LATEX LTD.
Date Published : 09/16/2009
A-33/A SECTOR-8 , Noida (U.P.), INDIA
85 H - - IR Perineometer
Date Published: 09/16/2009

Notes:Latex Condoms 7/6/1992

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 Est. , Palam Rd , Mumbai, INDIA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes:All devices DWI = 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 - - - -- Radiological
Date Published: 09/16/2009

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

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


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, Hamerkaz 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, TEL-AVIV ISRAEL
89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Date Published: 09/16/2009

Notes:Pollogen Regan 5/12/2009

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
Shatner Center 3 , Jerusalem, ISRAEL
82 - - - -- Immunology
Date Published: 09/16/2009

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.


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 F. Angrisani 18A , Agropoli, SA ITALY
79 G - - EX Laser Instrument, Surgical, Powered
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

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)
Date Published: 11/22/2011

Desc:Physia Pain Relief Machine
Notes:class II

Medical Electronic Devices International Co (MEDICO ITALIA)
Date Published : 09/16/2009
Via Pitagora 15 35030 , Rubano, 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: 09/29/2009

Notes:Class III (8/18/09)

86 L - - WL Fluid, Intraocular
Date Published: 09/29/2009

Notes:Class III (8/18/09)

Quadra Medical SRL
Date Published : 11/21/2012
Via Nardi, 98 Romano d'Ezzelino , Vience, 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 - - - -- Radiological
Date Published: 11/21/2012

Notes:All medical devices class I/II/III

Quadra Medical Srl
Date Published : 11/21/2012
Str Com Cartigliana 143 B , Bassano Del Grappabassano Del Grappa, 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 - - - -- Radiological
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, 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

RI. MOS S.R.L.
Date Published : 09/16/2009
Viale Gramsci, N.29 , Mirandola, MO 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

S. M. E. I. Srl
Date Published : 09/16/2009
Via F. Negri 15 , (Surg Med Aesthetic Supplies) , Casale Monferrato, AL ITALY
85 M - - GI Aspirator, Ultrasonic
Date Published: 09/16/2009

Notes:Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/1999

Sa Mas. S.r.l.
Date Published : 09/16/2009
Via Tarlazzi, 5 , 31014 Colle Umberto (TV) , 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:HBV 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

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

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

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


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
9-11,Showa-Cho , Higashiosaka-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
5-5-21 Nihonbashi,Naniwa-Ku , 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 - - - -- Radiological
Date Published: 09/16/2009

Hirayama Manufacturing Corp.
Date Published : 09/16/2009
2-16-16, Yushima, Bunkyo-Ku , Tokyo 113, 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 - - - -- Radiological
Date Published: 09/16/2009

Repro-Support Medical Research
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


KOREA, REPUBLIC OF (SOUTH)


ABATON IND
Date Published : 07/13/2011
SEOJUNG-DONG , Pyungtaek City, KOREA, REPUBLIC OF (SOUTH)
89 I - - LY Lamp, Infrared
Date Published: 07/13/2011

Desc:Abaton Far Infrared Massage Bed II Models (800 DX; MS and 800 SA)
Notes:Class II

BNB MEDICAL CO., LTD.
Date Published : 08/22/2011
#404 HYUNDAI HYEL , 779-11 JAYANG-DONG, GWANGJIN-GU , SEOUL, KOREA, REPUBLIC OF (SOUTH)
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

Bridget Lifescience Co Ltd
Date Published : 11/30/2011
12TH FL., SHINWOONG TOWER , 719 YEOKSAM2-DONG , GANGNAM-GU, SEOUL TEUGBYEOLSI KOREA, REPUBLIC OF (SOUTH)
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

Ceragem Medisys In
Date Published : 06/03/2015
16, Jeongjai-Gil, , Cheonan-si, KOREA, REPUBLIC OF (SOUTH)
79 G - - EX Laser Instrument, Surgical, Powered
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, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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
542-1 Daman-Ri, Jinrye-Myun , Gimhae, KOREA, REPUBLIC OF (SOUTH)
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, Busong 1-gil, Jiksan-eup, Seobuk-gu , Cheonan-si , Chungcheongnam-do, KOREA, REPUBLIC OF (SOUTH)
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

Dfi Co Ltd
Date Published : 01/04/2016
388 25 Gomoro Jill , Gyeongsangnam, KOREA, REPUBLIC OF (SOUTH)
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

DongBang Medical Co. Ltd.
Date Published : 10/22/2015
30 Saneopdanji-gil , Ungcheon-eup , Boryeong-si, Chungcheongnam-do KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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
Yangsan-si , 10 Yeongdong 2-GIL , Yangsan, Gyeongsangnam-do KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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

Enskin
Date Published : 10/11/2013
210 C-Dong, 145 Bundang Techo Park , Sungnam, Gyeonggi KOREA, REPUBLIC OF (SOUTH)
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
#1102-5 Hanra Sigma Valley Gasan-Dong , Seoul, KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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 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

G & G Contact Lens Co.
Date Published : 07/27/2010
4 Fl., Bummel Building 1287-1 , Bummel-Dong, Susung-Gu , Daegu, KOREA, REPUBLIC OF (SOUTH)
86 M - - ZD System, In-Office Tinting, Contact Lenses
Date Published: 07/27/2010

Desc:Circle Lenses
Notes:Class II

GS STANDARD ENG
Date Published : 11/29/2010
1006, BYUCKSAN 2CHA, 481-10 , GASAN-DONG, GEUMCHEON-GU , SEOUL, KOREA, REPUBLIC OF (SOUTH)
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

HANSOL MEDICAL
Date Published : 03/05/2012
344-2 YOUNG TAI RI , WOL RONG MYUN PAJU CITY KYOUNG GI-DO Kor , KYOUNG GI-DO, KR-41 KOREA, REPUBLIC OF (SOUTH)
84 M - - VV Device, Acupressure
Date Published: 03/05/2012

Desc:Bio Magnetic Cupping Set
Notes:class II

89 K - - NM Device, Pressure Applying
Date Published: 03/05/2012

Desc:Bio Magnetic Cupping Set
Notes:class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 03/05/2012

Desc:Bio Magnetic Cupping Set
Notes:class II

Hansol Medical
Date Published : 03/05/2012
89-12 Tongilro620beon-Gil , Weolrong-myeon , Paju-si, Gyeonggi-do KOREA, REPUBLIC OF (SOUTH)
84 M - - VV Device, Acupressure
Date Published: 03/05/2012

Desc:Bio Magnetic Cupping Set
Notes:Class II

89 K - - NM Device, Pressure Applying
Date Published: 03/05/2012

Desc:Bio Magnetic Cupping Set
Notes:Class II

89 L - - YG Massager, Therapeutic, Manual
Date Published: 03/05/2012

Desc:Bio Magnetic Cupping Set
Notes:Class II

Hesung Medical Supply Co., Ltd.
Date Published : 09/16/2009
517-4 Sangdaewon-Dong , CPO Box 9880 , Seongnom City, Seoul KOREA, REPUBLIC OF (SOUTH)
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes:All devices. DWI = 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 - - - -- Radiological
Date Published: 09/16/2009

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, REPUBLIC OF (SOUTH)
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

Interojo Inc.
Date Published : 05/23/2016
28 & 25 Sandan-Ro 15 Beon-Gil , Pyongtaek-citypyongtaek-city, KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
87 M - - QV Filler, Calcium Sulfate Preformed Pellets
Date Published: 01/27/2016

Desc:PolyBone Original (Bone Graft Substitute)

89 M - - BP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Date Published: 01/27/2016

Desc:PolyBone Original (Bone Graft Substitute)

LAON CO, LTD
Date Published : 10/29/2013
Siwha Industrial Complex , 2172-5 Jeongwang-Dong , Siheung, KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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 - - - -- Radiological
Date Published: 07/31/2012

Notes:All device products; Class I/II/III

Megatrend International
Date Published : 12/06/2010
207 Seowoo Bldg #497sangdo-1dong , Dongjak-kudongjak-ku, KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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

Neo Vision Co Ltd
Date Published : 11/09/2012
1667-5 Donghwa-Ri Munmak Eup , Gangwon-do, KOREA, REPUBLIC OF (SOUTH)
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

Neo Vision Co., Ltd.
Date Published : 11/09/2012
93 Jeungsin-ro , Iceon-si, Gyeonggi-do KOREA, REPUBLIC OF (SOUTH)
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

Nuga Medical Co., Ltd.
Date Published : 09/16/2009
185 Jiraeul-ro , Jijeong-myeon , Weonju-si, Gangweon-do KOREA, REPUBLIC OF (SOUTH)
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

Polytouch Co Ltd
Date Published : 11/20/2014
108-1 Hyeopseok-Ri Namcheon-Myeon , Gyeongsan-si, KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
73 B - - WI Needle, Acupuncture
Date Published: 02/13/2013

Desc:C-Cure skin pricking instrument with needles
Notes:class II

79 G - - ED Brush, Dermabrasion, Manual
Date Published: 02/13/2013

Desc:C-Cure skin pricking instrument with needles
Notes:class II

79 G - - FE Brush, Dermabrasion
Date Published: 02/13/2013

Desc:C-Cure skin pricking instrument with needles
Notes:class II

79 O - - UH Skin resurfacing rf applicator
Date Published: 02/13/2013

Desc:C-Cure skin pricking instrument with needles
Notes:class II

84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief
Date Published: 02/13/2013

Desc:C-Cure skin pricking instrument with needles
Notes:class II

84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes
Date Published: 02/13/2013

Desc:C-Cure skin pricking instrument with needles
Notes:class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 02/13/2013

Desc:C-Cure skin pricking instrument with needles
Notes:class II

SKINREX CO., LTD
Date Published : 11/25/2013
507HO JOONGANDINDUSPIA 2 , 144-5 SANGDAEWON-DONG, JUNGWON-GU , SEONGNAM-SI, KOREA, REPUBLIC OF (SOUTH)
89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/27/2016

Desc:Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT

89 I - - SA Massager, Therapeutic, Electric
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: 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

SONIC WORLD CO., LTD.
Date Published : 11/20/2015
131 Donghwagongdan-ro , Wonju-si, Gangwon-do KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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

Seju Engineering Co., Ltd.
Date Published : 09/16/2009
611-1, Guam-dong, , Yusung-gu , Daejon City, Chuongnam, KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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

The Standard Company
Date Published : 11/29/2010
1007 Byucksan 2cha, 481-10 , Gasan-dong, Geumcheaon-gu , Seoul, KOREA, REPUBLIC OF (SOUTH)
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
726-74 Hannam-Dong, Suit 1009, , Seoul, KOREA, REPUBLIC OF (SOUTH)
86 - - - -- Ophthalmic
Date Published: 07/27/2010

Desc:All Contact Lenses
Notes:Class II; III

Theg Korea, Inc.
Date Published : 07/27/2010
Suite 1508 Taechidong 889 5 , Seoul, Seoul Teugbyeolsi KOREA, REPUBLIC OF (SOUTH)
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 , Gangnae-Myeon , Cheongju Si, KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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 - - - -- Radiological
Date Published: 09/16/2009

Vassen Co. Ltd.
Date Published : 11/18/2011
260-1 Habuk-Ri Jinwee-Myun , Pyongtaek City, Gyeonggi-di KOREA, REPUBLIC OF (SOUTH)
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
212 2nd Fl Garo Gongwon Rd Hwagok 1 , Seoul, KOREA, REPUBLIC OF (SOUTH)
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

WON TECHNOLOGY CO., LTD.
Date Published : 09/29/2009
538, DAEDEOK TECHNO VALLEY , YONGSAN-DONG, YUSUNG-GU, KOREA, REPUBLIC OF (SOUTH)
79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 09/29/2009

Desc:SkinClear SRVH
Notes:Class II

Winners Co., Ltd.
Date Published : 05/10/2012
2F, 76-1, Yeongtong-dong , Yeongtong-gu , Suwon-Si, GyeongGi-Dong KOREA, REPUBLIC OF (SOUTH)
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 - - - -- Radiological
Date Published: 05/10/2012

Notes:All medical devices; class II

Won Industry Co.
Date Published : 12/15/2016
7-12 Bangadari-Gil , Siheung-si, Gyeonggi-do KOREA, REPUBLIC OF (SOUTH)
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

Young Chemical Co., Ltd.
Date Published : 06/08/2017
80-93, Golden root-ro , Juchon-myeon , Gimhae-si, Gyeongsangnamdo KOREA, REPUBLIC OF (SOUTH)
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


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


LUXEMBOURG


Biotech Industry
Date Published : 09/16/2009
212 Bernard Haal , Luxembourg, 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


Alang Bidara Industries Sdn Bhd
Date Published : 09/16/2009
2574 Kampong Olak Lembit , Kuala Langat, MALAYSIA
80 F - - MC Glove, Patient Examination
Date Published: 09/16/2009

Notes:Latext patient Examination Gloves

80 L - - YY Glove, Patient Examination, Latex
Date Published: 09/16/2009

Notes:Latext patient Examination Gloves

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 - - - -- Radiological
Date Published: 09/29/2011

Notes:All devices; Class II/III

Innolatex Sdn. Bhd.
Date Published : 08/14/2012
Lot 594, Pandamaran Industrial Estate , Persiaran Raja Lumu , Port Klang, Selangor MALAYSIA
85 M - - SC Barrier, Std, Oral Sex
Date Published: 08/14/2012

Desc:Dams Female Condoms
Notes:class II

85 O - - BU Female condom, repeated use
Date Published: 08/14/2012

Desc:Dams Female Condoms
Notes:class II

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

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 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 & GOZO


ORBISAN LTD
Date Published : 05/23/2012
UB3A INDUSTRIAL ESTATE , San Gwann, SAN GWANN MALTA & GOZO
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
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
175-101 Cuernavaca , Col Condesa , Mexico City, 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
JOSE BENITEZ 2704 , MONTERREY, MX-HID MEXICO
89 O - - NH Powered laser non-themal instrument with non-heating effect for adjunctive use in path therapy
Date Published: 08/30/2013

Desc:Acupuntador
Notes:class II

Industrias Manufactureras De Tamaulipas S.A. de C.V.
Date Published : 01/22/2010
Zaragoza #203 , 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.


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 L - - DQ Device, General Medical
Date Published: 11/03/2016

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

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


NETHERLANDS ANTILLES


Metradco MV
Date Published : 03/08/2011
Unknown Street , Curacao, NETHERLANDS ANTILLES
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

Desc:Stimulator Electro-Acupuncture
Notes:Class III


PAKISTAN


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
80 L - - DQ Device, General Medical
Date Published: 11/16/2016

Desc:Sleep Mask

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


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


Genelabs Diagnostics Pte Ltd.
Date Published : 09/16/2009
85 Science Park Drive ,#04-01 the Cavend , Singapore Science Park , Singapore, SINGAPORE
55 Y - - 99 Pharmaceutic Necessities and Containers, N.E.C.
Date Published: 09/16/2009

Notes:Ora Screen 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.

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

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: 09/16/2009

Notes:Blood Pressure Monitors Massagers Muscle Stimulators 4/29/2005

74 D - - XQ Cuff, Blood-Pressure
Date Published: 09/16/2009

Notes:Blood Pressure Monitors Massagers Muscle Stimulators 4/29/2005

84 G - - ZI Stimulator, Neuromuscular, External Functional
Date Published: 09/16/2009

Notes:Blood Pressure Monitors Massagers Muscle Stimulators 4/29/2005

89 M - - PH Stimulator, Electrical, Muscle
Date Published: 09/16/2009

Notes:Blood Pressure Monitors Massagers Muscle Stimulators 4/29/2005

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes:Blood Pressure Monitors Massagers Muscle Stimulators 4/29/2005


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 RD, BEACONVALE PAROW , 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 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. ; ;

80 L - - DQ Device, General Medical
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. ;

89 N - - ZF Massager, cosmetic, static electricity-emitting
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. ;

Health Technology (Pty) Ltd
Date Published : 04/02/2014
Unit 3, 6 Palmfield Road , Springfield Park, SOUTH AFRICA
89 I - - LY Lamp, Infrared
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

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

91 N - - ED Kit, Test, Malaria,
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

91 N - - ED Kit, Test, Malaria,
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

91 N - - ED Kit, Test, Malaria,
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

91 N - - ED Kit, Test, Malaria,
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

91 N - - ED Kit, Test, Malaria,
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 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.

80 L - - DQ Device, General Medical
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.

89 N - - ZF Massager, cosmetic, static electricity-emitting
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.


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)

Orkla Care AB
Date Published : 05/19/2011
Kanalvagen 5 A , Upplands Vasby, 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, SWEDEN
75 L - - ZX Acid, Sodium Hyaluronic
Date Published: 09/16/2009

Notes:Perlane Sodium Hyaluronic Acid 6/3/2002

80 L - - DQ Device, General Medical
Date Published: 09/16/2009

Notes:Perlane Sodium Hyaluronic Acid 6/3/2002

89 L - - ZX Acid, Sodium Hyaluronic, Intra-articular
Date Published: 09/16/2009

Notes:Perlane Sodium Hyaluronic Acid 6/3/2002

89 M - - OZ Acid, Hyaluronic, Intraarticular
Date Published: 09/16/2009

Notes:Perlane Sodium Hyaluronic Acid 6/3/2002

Scandicare Products Ab
Date Published : 09/16/2009
Box 24 , Andestorp, 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.


SWITZERLAND


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 - - - -- Radiological
Date Published: 09/16/2009

Compex Sa
Date Published : 09/16/2009
Zi Larges Pieces , Ecublens, SWITZERLAND
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 09/16/2009

Notes:Compex 2 Iontophotoresis.

Connectorate Ag
Date Published : 10/28/2010
Bernstrasse 390 , Dietikon, SWITZERLAND
76 K - - OK Sterilizer, Endodontic Dry Heat
Date Published: 10/28/2010

Desc:Glass bead sterilizers
Notes:Class III

Corange International
Date Published : 09/16/2009
Hamilton Cham Branch Hinterbergstrasse 9 , Postbach 5146 , Cham, 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

Hamo Ag
Date Published : 09/16/2009
Bielstrasso 76 Ch 2542 , Pieterlen, SWITZERLAND
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes:All devices. DWI = 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 - - - -- Radiological
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
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 09/16/2009

Notes:Zepter Cosmetics Electro-Acupuncture Device 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 - - - -- Radiological
Date Published: 07/21/2017

Notes:All Devices

Mediatronic S.A.
Date Published : 09/16/2009
5C Route Des Jeunes , 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 - - - -- Radiological
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

Peschke Meditrade Gmbh
Date Published : 10/16/2015
Boesch 65 , Huenenberg, SWITZERLAND
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 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:                                                                                                                                                                                                                                

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 Vario Demo Unit
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 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 Vario Demo Unit
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:Phoenix 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 Vario Demo For Trade Show
Notes:                                                                                                                                                                                                                                  

95 R - - EG Suntan Lamp, Sunlamp Products (Certified), Non-Medical
Date Published: 10/16/2015

Desc:UV Lamp
Notes:                                                                                                                                                                                                                                

95 R - - HW Uv lamp for home or business uses
Date Published: 10/16/2015

Desc:UV Lamp
Notes:                                                                                                                                                                                                                                  

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

Teoxane S.A.
Date Published : 03/08/2013
Rue De Lyon 105 , Gen¿ve, Ge SWITZERLAND
73 - - - -- Anesthesiology
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

74 - - - -- Cardiovascular
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

76 - - - -- Dental
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

77 - - - -- Ear,Nose And Throat
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

78 - - - -- Gastroenterological & Urological
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 03/08/2013

Desc:Teosyal PureSense Deep Lines (TS27L)
Notes:class II

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 03/08/2013

Desc:Teosyal PureSense Ultra Deep (TSUL)
Notes:class II

79 L - - MH Implant, Dermal, Collagen for Aesthetic Use
Date Published: 03/08/2013

Desc:Teosyal PureSense Global Action (TS30L)
Notes:class II

79 - - - -- General & Plastic Surgery
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

80 - - - -- General Hospital/Personal Use
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

84 - - - -- Neurological
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

85 - - - -- Obstetrical & Gynecological
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

86 - - - -- Ophthalmic
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

87 - - - -- Orthopedic
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

89 - - - -- Physical Medicine
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III

90 - - - -- Radiological
Date Published: 06/05/2013

Notes:All Devices; Class I, II, III


TAIWAN


Acute Ideas Co., Ltd.
Date Published : 09/16/2009
5F - 10, No. 3 Tien Mu West Road , 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. >>> HTI Inc. 10002 W. Markham Little Rock, Arkansas 72205 <<< >>> IMCO Technologies, Inc. 10002 W. Markham, Suite 200 Little Rock, Arkansas 72205 <<<

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 - - - -- Radiological
Date Published: 09/16/2009

General Biologicals
Date Published : 01/22/2016
No 6 Innovation First Rd Science-Based , 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

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

Kenmajor Ent. Co.,
Date Published : 06/13/2012
Sec.5 Sinty , Taipei City, TAIWAN
52 A - - 36 Glass tumbler, drinking glass (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

80 L - - DQ Device, General Medical
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 - - - -- Radiological
Date Published: 09/16/2009

Measure Technology Co., Ltd.
Date Published : 07/21/2017
7F,NO. 86, 88 & 88-1, SEC.1 , KWANG FU ROAD SAN CHUNG DIST , Taipei Hsien, TAIWAN
79 M - - YH System, Non-Coherent Light, Photodynamic Therapy
Date Published: 07/21/2017

Desc:Nasal Relief Pinguin

Mesure Technology Co., Ltd
Date Published : 07/21/2017
NO. 4, 6 F , Lane 83, Sec. 1; Kwang Fu Road , San Chung City, Taipei, 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
No 2 Lane 63 Wu Hwa St , San Chung City, TAIWAN
79 G - - FD Dermatome
Date Published: 06/04/2012

Desc:M-399 Diamond Peel Dematome; Massager
Notes:Class II

Taiwan Creations
Date Published : 03/08/2011
112 Chung Shan Rd , Taipei, TAIWAN
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

Desc:Alpha-wave Healthtronic; MuscleStimulator and Slimming Device
Notes:Class III

Taiwan Creations
Date Published : 03/08/2011
No 7 Pao Chiao Rd. , Shin-Tien, TAIWAN
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

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
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

Desc:Alpha-wave Healthtronic; MuscleStimulator and Slimming Device
Notes:Class III

Taiwan Creations Joe L. Co., Ltd.
Date Published : 03/08/2011
5F, No. 7, Lane 235, Pao-Chiao Road , Shin-Tien City, Taipei, TAIWAN
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

Desc:Alpha-wave Healthtronic; MuscleStimulator and Slimming Device
Notes:Class III

Taiwan Creations Joe L. Co., Ltd.
Date Published : 03/08/2011
6 Fl No. 5 Alley 235 Pao Chiao Rd. , Hsin Tien City Taipei Taiwan, TAIWAN
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

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
82 M - - VZ System, Test, Home, HIV-1
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.

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
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

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
11F, No. 288, Sec. 3, San Min Road , Taoyuan City, TAIWAN
89 I - - LY Lamp, Infrared
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


TURKEY


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.


UKRAINE


Consultative & Commercial Center " INVET"
Date Published : 09/16/2009
Ac. Zabolotny Str 35/37 , Odessa, UKRAINE
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


UNITED KINGDOM


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.

Auto-Compute Trading Ltd
Date Published : 03/08/2011
Southall , Middlesex, England UNITED KINGDOM
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

Desc:Stimulator Electro-Acupuncture
Notes:Class III

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

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

Bodywise Limited
Date Published : 08/22/2016
Unit 8, Enterprise Way Somerto Trading , Cowes, Isle Of White, 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: 09/16/2009

Notes:Lipdren Muscle Stimulator 7/20/2005

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes:Lipdren Muscle Stimulator 7/20/2005

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 09/16/2009

Notes:Lipdren Muscle Stimulator 7/20/2005

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes:Lipdren Muscle Stimulator 7/20/2005

CACI International
Date Published : 07/19/2011
CACI House 9 Spring Villa Park, , Spring Villa Road , Edgware, UNITED KINGDOM
80 L - - DQ Device, General Medical
Date Published: 07/19/2011

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

89 N - - ZF Massager, cosmetic, static electricity-emitting
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

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

Daysoft Limited
Date Published : 08/01/2011
5 Livingstone Blvd , North Lanarkshi, 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
Unit 55 Halifax Way , 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)

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

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

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 - - - -- Radiological
Date Published: 12/01/2011

Notes:Massager; Class II

Good Night Snoring
Date Published : 12/22/2014
Po Box 1438 , Surrey, UNITED KINGDOM
77 L - - RK Device, Anti-Snoring
Date Published: 12/22/2014

Desc:Anti Snoring Ring

84 M - - VV Device, Acupressure
Date Published: 12/22/2014

Desc:Anti Snoring Ring

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 - - - -- Radiological
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 - - - -- Radiological
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
57 Victoria Street , 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

Itinstock
Date Published : 12/01/2011
1 & 1a Chase Side Works , 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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 12/01/2011

Notes:Massager; Class II

Kays Electronics Ltd
Date Published : 11/30/2011
85 Cavendish Street , Ipswichipswich, 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 - - - -- Radiological
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 - - XI Cuff, Nerve
Date Published: 09/16/2009

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

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
80 L - - DQ Device, General Medical
Date Published: 07/19/2011

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

89 N - - ZF Massager, cosmetic, static electricity-emitting
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

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 - - - -- Radiological
Date Published: 12/01/2011

Notes:Massager; Class II

Optipak Limited
Date Published : 09/16/2009
49-53 York Street , Twickenham, Middlesex, UNITED KINGDOM
86 L - - RX Case, Contact Lens
Date Published: 09/16/2009

Notes:"I clean" antibacterial contact lens soaking case 9/3/2008

Perfector Skincare
Date Published : 12/01/2011
26-32 Oxford Rd , 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 - - - -- Radiological
Date Published: 12/01/2011

Notes:Massager; Class II

Perfector Skincare Ltd./Arasys Ltd.
Date Published : 12/01/2011
Home Life House, , 26-32 Oxford 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 - - - -- Radiological
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: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

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: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

Puretone Ltd.
Date Published : 09/16/2009
9-10 Henley Business Park , Trident Close, Medway City Estate , Rochester, 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
73 B - - WK Stimulator, Electro-Acupuncture
Date Published: 03/08/2011

Desc:Stimulator Electro-Acupuncture
Notes:Class III

Sauflon Pharmaceuticals Limited
Date Published : 09/16/2009
49-53 York Street , Twickenham Middlesex, 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, 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

Smilegems Ltd
Date Published : 07/23/2012
5 Market Place Long Buckbylong , Northamptonnorthampton, UNITED KINGDOM
76 D - - YH Adhesive, Bracket And Tooth Conditioner, Resin
Date Published: 07/23/2012

Desc:Smilegems Temporary Tooth Jewels
Notes:Class II

T&H Manufacturing Ltd
Date Published : 12/01/2011
Unit 5 Ventura Centre , Upton, 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 - - - -- Radiological
Date Published: 12/01/2011

Notes:Massager; Class II

The Garden Pharmacy
Date Published : 09/16/2009
119 Long Acre , London, UNITED KINGDOM
85 M - - EE Device, Fertility Diagnostic, Contraceptive
Date Published: 09/16/2009

Notes:Shipper for Unipath Ltd. Personal Contraceptive Monitor. 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
Date Published : 06/15/2010
Mallard Ind Pk Ch , Wakefield, UNITED KINGDOM
78 L - - KY Device, External Penile Rigidity
Date Published: 06/15/2010

Desc:Penis Pump
Notes:Class III

Um Products Ltd
Date Published : 01/17/2014
Units 4-6 Mallard Industrial Park , Wakefield, UNITED KINGDOM
78 L - - KY Device, External Penile Rigidity
Date Published: 01/17/2014

Desc:Penis Pump
Notes:class III

Unipath Limited
Date Published : 09/16/2009
Business Park Stannard Way Priory Busine , Bedford, UNITED KINGDOM
85 M - - EE Device, Fertility Diagnostic, Contraceptive
Date Published: 09/16/2009

Notes:Personal Contraceptive Monitor 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)

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


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

80 L - - DQ Device, General Medical
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 Health Llc
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

Micro Current Technology Inc
Date Published : 04/23/2012
2244 1st Ave S , Seattle, WA 98134-1408 UNITED STATES
79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 04/23/2012

Desc:Bio Synthesis Light activated
Notes:class II

79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 04/23/2012

Desc:Bio Hydroderm V2 Microderm Abrasion units
Notes:class II

79 G - - EX Laser Instrument, Surgical, Powered
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 Hydrodermabrasion System
Notes:Class II

79 G - - FD Dermatome
Date Published: 04/23/2012

Desc:Bio Hydroderm V2 Microderm Abrasion units
Notes:Class II

79 G - - FD Dermatome
Date Published: 04/23/2012

Desc:Bio Synthesis Light activated
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)