Import Alert 89-04
(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 # 89-04
Published Date: 11/21/2024
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements"
Reason for Alert:
Note:
Revisions of this Import Alert dated 05/10/2021 updated the reason for alert section, guidance section, product description section, and charge section. Changes are bracketed by asterisks (***).
Foreign inspection of device manufacturers are being performed and detention without physical examination (DWPE) may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's). Detention Without Physical Examination (DWPE) may be appropriate when an FDA foreign inspection of a device manufacturer has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).
DWPE may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveal conditions or practices warranting detention of either particular products or all products manufactured by a firm. DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by re-inspection or submission of appropriate documentation to the FDA.
Revisions of this Import Alert dated 05/10/2021 updated the reason for alert section, guidance section, product description section, and charge section. Changes are bracketed by asterisks (***).
Foreign inspection of device manufacturers are being performed and detention without physical examination (DWPE) may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's). Detention Without Physical Examination (DWPE) may be appropriate when an FDA foreign inspection of a device manufacturer has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).
DWPE may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveal conditions or practices warranting detention of either particular products or all products manufactured by a firm. DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by re-inspection or submission of appropriate documentation to the FDA.
Guidance:
***Divisions may detain, without physical examination, products from the manufacturers identified in the Red List for this import alert.***
A recommendation for addition to detention without physical examination and background information should be forwarded to DIO. DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH Imports and Registration & Listing Team (IRLT).
Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: CDRH Import Mailbox cdrhimport@fda.hhs.gov
"
A recommendation for addition to detention without physical examination and background information should be forwarded to DIO. DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH Imports and Registration & Listing Team (IRLT).
Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: CDRH Import Mailbox cdrhimport@fda.hhs.gov
"
Product Description:
***All medical devices***
Charge:
***The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act [Adulteration, Section 501(h)]OASIS charge code: DEVICEGMPS***
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
ARGENTINA
Cidal Sa
Date Published : 09/16/2009
Avenida Dr Rodolfo Freyre 1635
, Santa Fe,
Santa Fe ARGENTINA
85 H - - IS Condom
Date Published: 02/15/2019
Desc: Latex Condoms
Notes: 12/27/1994
F.P. Rubinstein Y Cia SRL
Date Published : 04/20/2016
Calle David Luque 519
, Cordoba,
Cordoba ARGENTINA
73 - - - -- Anesthesiology
Date Published: 04/20/2016
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 04/20/2016
Notes: All medical devices
76 - - - -- Dental
Date Published: 04/20/2016
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 04/20/2016
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 04/20/2016
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 04/20/2016
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 04/20/2016
Notes: All medical devices
84 - - - -- Neurological
Date Published: 04/20/2016
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 04/20/2016
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 04/20/2016
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 04/20/2016
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 04/20/2016
Notes: All medical devices
90 - - - -- Radiology
Date Published: 04/20/2016
Notes: All medical devices
Unimed
Date Published : 09/16/2009
Calle 97, N. 2156, Exfelix Ballister 23
, San Martin,
ARGENTINA
74 D - - XE Catheter, Embolectomy
Date Published: 02/07/2019
Notes: Embolectomy Catheter; Classification Name - Catheter; Embolectomy; Classification Number - 74DXE; Class II Regulation Citation - 21CFR 870.5150; 11/5/1993
78 F - - GE Stents, drains and dilators for the biliary ducts
Date Published: 02/07/2019
Notes: Biliary Catheter; Classification name; catheter; billiary; classificaton number 78fGE; Class II. Regulation 21 CFR 876.5010; 11/5/1993
79 G - - BQ Catheter, Continuous Irrigation
Date Published: 02/07/2019
Notes: Pleural Drain: Classification Name; Catheter; Continuous Irrigation Classification Number 79GBQ Class II Regulation Citation CFR 878.42000 ; 11/5/1993
AUSTRALIA
Advanced Surgical Design & Manufacture, Ltd.
Date Published : 12/06/2010
U 2 12 Frederick St
, St Leonards,
New South Wales AUSTRALIA
79 L - - RP Tray, Surgical
Date Published: 08/31/2011
Desc: Active Total Knee System and associated surgical tools
87 H - - RY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Date Published: 12/06/2010
Desc: Active Total Knee System and associated surgical tools
87 H - - WC Screw, Fixation, Bone
Date Published: 08/31/2011
Desc: Active Total Knee System and associated surgical tools
87 J - - WH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Date Published: 12/06/2010
Desc: Active Total Knee System and associated surgical tools
87 L - - XH Orthopedic Manual Surgical Instrument
Date Published: 08/31/2011
Desc: Active Total Knee System and associated surgical tools
89 I - - SY Joint, Knee, External Limb Component
Date Published: 08/31/2011
Desc: Active Total Knee System and associated surgical tools
CIGWELD
Date Published : 09/16/2009
85 Chifley Dr
, Preston,
Victoria AUSTRALIA
73 B - - TM Ventilator, Emergency, Manual (Resuscitator)
Date Published: 09/16/2009
Notes: 9/25/1998
TFS MANUFACTURING PTY LTD
Date Published : 01/26/2016
3 Charles St
, Allenby Gardens,
South Australia AUSTRALIA
73 - - - -- Anesthesiology
Date Published: 01/26/2016
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 01/26/2016
Notes: All medical devices
76 - - - -- Dental
Date Published: 01/26/2016
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 01/26/2016
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 01/26/2016
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 01/26/2016
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 01/26/2016
Notes: All medical devices
84 - - - -- Neurological
Date Published: 01/26/2016
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 01/26/2016
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 01/26/2016
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 01/26/2016
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 01/26/2016
Notes: All medical devices
90 - - - -- Radiology
Date Published: 01/26/2016
Notes: All medical devices
Telectronics Pty., Ltd.
Date Published : 09/16/2009
2 Sirius Road
, Lane Cove,
NSW AUSTRALIA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: All devices ; Exempt Implantable cardiverter defibrillators model numbers 4211, 4215, 4310. Product code : 74LWS ; (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996;
75 - - - -- Chemistry
Date Published: 02/06/2019
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
76 - - - -- Dental
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
81 - - - -- Hematology
Date Published: 02/06/2019
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
82 - - - -- Immunology
Date Published: 02/06/2019
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
83 - - - -- Microbiology
Date Published: 02/06/2019
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
88 - - - -- Pathology
Date Published: 02/06/2019
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
91 - - - -- Toxicology
Date Published: 02/06/2019
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
92 - - - -- Molecular Genetics
Date Published: 02/06/2019
Notes: All devices except implantable cardiverter defibrillators model numbers 4211,
4215, 4310. (7/17/1995);
Revised product information 5/6/96;
Parts Used in model 9600 network programmer printed circuit boards:
a. 9600 main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised product information on 5/6/1996
BELGIUM
Belgium Hospital Services N.V.
Date Published : 09/16/2009
Boomsesteenweg 939
, Antwerp,
Wilrijk BELGIUM
80 B - - RZ Set, Blood Transfusion
Date Published: 09/16/2009
Notes: 9/11/1992
BRAZIL
Laboratorios B. Braun S.A.
Date Published : 09/16/2009
Avenida Doutor Eugenio Borges, 1092
, Sao Goncalo,
Rio de Janeiro BRAZIL
89 - - - -- Physical Medicine
Date Published: 09/16/2009
BULGARIA
X12 Co., LTD.
Date Published : 04/05/2017
J&L Center, Fl. 4, Rm. 418 , 46 Lubliana Str.
, Sofia,
Sofia BULGARIA
73 - - - -- Anesthesiology
Date Published: 04/05/2017
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 04/05/2017
Notes: All medical devices
76 - - - -- Dental
Date Published: 04/05/2017
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 04/05/2017
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 04/05/2017
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 04/05/2017
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 04/05/2017
Notes: All medical devices
84 - - - -- Neurological
Date Published: 04/05/2017
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 04/05/2017
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 04/05/2017
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 04/05/2017
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 04/05/2017
Notes: All medical devices
90 - - - -- Radiology
Date Published: 04/05/2017
Notes: All medical devices
CANADA
Activa Brand Products, Inc.
Date Published : 09/16/2009
112 W B Macphail Dr
, Cornwall,
Prince Edward Island CANADA
80 K - - ZE Injector, Fluid, Non-Electrically Powered
Date Published: 09/16/2009
Notes: 8/15/2007
Aiken Enterprises
Date Published : 09/16/2009
577 Four Winds Way
, Mississauga,
Ontario CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Biosig Instruments Inc.
Date Published : 01/30/2019
440 - 19th Ave Suite 100
, Lachine,
QC CANADA
74 - - - -- Cardiovascular
Date Published: 01/30/2019
Notes: Intra - pulse Heart Rate Monitor; 105; 107; 201; 302; 303; Telepulse (T.M) Radio Telemetry Heart Rate Monitor Model 803; Antache (R) Anti-Headache Device (EMG Biofeedback System) Atense (R) Anti-tension Device (EMG Biofeedback System) Model 701; 08/05/1993
Canix Sterilizer Inc.
Date Published : 09/16/2009
7085 Tomken Road
, Mississauga,
ON CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices.
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Cyex Medical Technologies Inc
Date Published : 09/16/2009
91 Kelfield St Unit 5
, Etobicoke,
ON CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: Sterile Device Class II 5/15/1996
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Gmp Inc
Date Published : 09/16/2009
1100 Invicta Dr
, Oakville,
ON CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Hedy Canada
Date Published : 09/16/2009
#r1350 42 Ave Se
, Calgary,
CANADA
80 F - - MC Glove, Patient Examination
Date Published: 02/11/2019
Desc: Latex Examination Gloves (non-sterile)
Notes: 7/1/1997
80 L - - YY Glove, Patient Examination, Latex
Date Published: 02/11/2019
Desc: Latex Examination Gloves (non-sterile)
Notes: 7/1/1997
IND Diagnostic Inc.
Date Published : 02/25/2013
1629 Foster's Way
, Delta,
British Columbia CANADA
73 - - - -- Anesthesiology
Date Published: 02/25/2013
Notes: All Medical devices
74 - - - -- Cardiovascular
Date Published: 02/25/2013
Notes: All Medical devices
76 - - - -- Dental
Date Published: 02/25/2013
Notes: All Medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 02/25/2013
Notes: All Medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 02/25/2013
Notes: All Medical devices
79 - - - -- General & Plastic Surgery
Date Published: 02/25/2013
Notes: All Medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 02/25/2013
Notes: All Medical devices
84 - - - -- Neurological
Date Published: 02/25/2013
Notes: All Medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 02/25/2013
Notes: All Medical devices
86 - - - -- Ophthalmic
Date Published: 02/25/2013
Notes: All Medical devices
87 - - - -- Orthopedic
Date Published: 02/25/2013
Notes: All Medical devices
89 - - - -- Physical Medicine
Date Published: 02/25/2013
Notes: All Medical devices
90 - - - -- Radiology
Date Published: 02/25/2013
Notes: All Medical devices
94 - - - -- Ionizing Non-Medical Devices and Components
Date Published: 02/25/2013
Notes: All Medical devices
95 - - - -- Light Emitting Non-Device Products
Date Published: 02/25/2013
Notes: All Medical devices
96 - - - -- Radio Frequency Emitting Products
Date Published: 02/25/2013
Notes: All Medical devices
97 - - - -- Sound Emitting Products
Date Published: 02/25/2013
Notes: All Medical devices
Med-Ex Diagnostics Of Canada, Inc.
Date Published : 09/16/2009
51 Leeder Avenue
, Coquitlam,
BC CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices.
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
NIPRO CANADA CORPORATION
Date Published : 10/25/2018
199 St. David St
, Lindsay,
Ontario CANADA
78 M - - SD Catheter, Hemodialysis, Implanted
Date Published: 10/25/2018
Desc: Dual Floating Dialysis Catheter/Tray
80 L - - HI Set, I.V. Fluid Transer
Date Published: 10/25/2018
Desc: Phlebotomy Bag with Valve
National Home Products Limited
Date Published : 09/16/2009
188 Limestone Cres
, North York,
Ontario CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
76 - - - -- Dental
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
Progressive Chemical Research, Ltd.
Date Published : 09/16/2009
1410 40th Avenue, N.E. #20
, Calgary,
AB CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices/GPI=DE with the exception of the Alberta Lens S. 8/22/2000
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Shemberg Corp
Date Published : 09/16/2009
49 Belinda Sq
, Scarborough,
ON CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination. 7/5/2000
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
76 - - - -- Dental
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past two years. Entry documentation for devices shipped by the firms should be reviewed to determine if they have been sterilized by Carix Sterilizers and therefore may be subject to detention without physical examination. 7/5/2000
TREXO ROBOTICS HOLDINGS
Date Published : 07/02/2024
5700 Timberlea Blvd , Uni
, Mississauga,
Ontario CANADA
89 - - - -- Physical Medicine
Date Published: 07/02/2024
Desc: All Devices
Trexo Robotics Holdings Inc.
Date Published : 07/02/2024
6705 Millcreek Dr Unit 3
, Mississauga,
Ontario CANADA
89 - - - -- Physical Medicine
Date Published: 07/02/2024
Desc: All Devices
Tube Fab Ltd
Date Published : 09/16/2009
36 Fourth St
, Charlottetown,
Prince Edward Island CANADA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
76 - - - -- Dental
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: This firm may have had products processed by Canix Sterilizer within the past
two years. Entry documentation for devices shipped by the firms should be
reviewed to determine if they have been sterilized by Carix Sterilizers and
therefore may be subject to detention without physical examination.; 7/5/2000
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: Ultrasoft Laboratories is also recommended for DWPE under import alert #89-08.
movingpeople.Net Canada, Inc.
Date Published : 02/07/2019
500 Norfinch Drive
, North York,
ON CANADA
89 I - - NI Vehicle, Motorized 3-Wheeled
Date Published: 02/07/2019
Desc: Power Scooter
Notes: Fortress Models 1700;1704; 2000 and 2001; 9/25/2002
89 I - - NO Chair, Positioning, Electric
Date Published: 02/07/2019
Desc: Corsaire Power Chair
Notes: 9/25/2002
CHINA
Beijing Unisoft Contact Lens Co., Ltd.
Date Published : 01/29/2019
114 Xuanxidajie
, Beijing,
Beijing CHINA
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 01/29/2019
Desc: Soft Contact Lenses
Notes: 2/08/1995
86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 01/29/2019
Desc: Soft Contact Lenses
Notes: 2/08/1995
Beyond Technology Corporation Nanchang
Date Published : 08/29/2016
NO 162 Kejidadao , Qingshanhu
, Nanchang,
CHINA
73 - - - -- Anesthesiology
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
74 - - - -- Cardiovascular
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
76 - - - -- Dental
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
77 - - - -- Ear,Nose And Throat
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
78 - - - -- Gastroenterological & Urological
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
79 - - - -- General & Plastic Surgery
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
80 - - - -- General Hospital/Personal Use
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
84 - - - -- Neurological
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
85 - - - -- Obstetrical & Gynecological
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
86 - - - -- Ophthalmic
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
87 - - - -- Orthopedic
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
89 - - - -- Physical Medicine
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
90 - - - -- Radiology
Date Published: 08/29/2016
Notes: All devices;
Note: Medical device shipments from Beyond Technology Corp with an address of
West Side of Wuhua North Road, Wangchen New District, Nanchang, China are
also subject to this Import Alert.
DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD
Date Published : 10/16/2019
Bihu Ave., Jinqi Rd. Bldg. #3 6 , 7 Floors; Feng Gang Town
, Dongguan,
Guangdong CHINA
85 H - - GH Cannula, Suction, Uterine
Date Published: 10/16/2019
Desc: Micro View Disposable Endoscopic Cannula
Dongguan Jianwei Electronics Products Co., Ltd.
Date Published : 05/18/2017
No. 406 Qing Feng Road , Qing-Xi Town
, Dongguan City,
Guang-Dong CHINA
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 05/18/2017
Desc: Infrared Ear Thermometers
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 05/18/2017
Desc: Digital Thermometers
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 05/18/2017
Desc: Rectal Thermometers
Guilin Zizhu Latex Co., Ltd
Date Published : 08/25/2015
No. 6 Wushan Road
, Guilin,
Guangxizhuangzuzizhiqu CHINA
73 - - - -- Anesthesiology
Date Published: 08/25/2015
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 08/25/2015
Notes: All medical devices
76 - - - -- Dental
Date Published: 08/25/2015
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 08/25/2015
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 08/25/2015
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 08/25/2015
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 08/25/2015
Notes: All medical devices
84 - - - -- Neurological
Date Published: 08/25/2015
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 08/25/2015
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 08/25/2015
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 08/25/2015
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 08/25/2015
Notes: All medical devices
90 - - - -- Radiology
Date Published: 08/25/2015
Notes: All medical devices
HUBEI HONGKANG PROTECTIVE PRODUCTS CO
Date Published : 09/27/2016
NO 1 Qingshuiwan , Xiantao
, Huanggang,
Hubei CHINA
73 - - - -- Anesthesiology
Date Published: 09/27/2016
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 09/27/2016
Notes: All medical devices
76 - - - -- Dental
Date Published: 09/27/2016
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 09/27/2016
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 09/27/2016
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 09/27/2016
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 09/27/2016
Notes: All medical devices
84 - - - -- Neurological
Date Published: 09/27/2016
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 09/27/2016
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 09/27/2016
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 09/27/2016
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 09/27/2016
Notes: All medical devices
90 - - - -- Radiology
Date Published: 09/27/2016
Notes: All medical devices
HanChuan FuMo Plastics Co., Ltd.
Date Published : 06/16/2015
# 56 Zhengjie Rd. Chenghuang
, Hanchuan,
Hubie CHINA
73 - - - -- Anesthesiology
Date Published: 06/16/2015
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 06/16/2015
Notes: All medical devices
76 - - - -- Dental
Date Published: 06/16/2015
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 06/16/2015
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 06/16/2015
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 06/16/2015
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 06/16/2015
Notes: All medical devices
84 - - - -- Neurological
Date Published: 06/16/2015
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 06/16/2015
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 06/16/2015
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 06/16/2015
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 06/16/2015
Notes: All medical devices
90 - - - -- Radiology
Date Published: 06/16/2015
Notes: All medical devices
Hebei Pukang Medical Instruments Co., Ltd.
Date Published : 05/22/2017
Dongshiduan Town , Xushui County
, Baoding,
Hebei CHINA
73 - - - -- Anesthesiology
Date Published: 05/22/2017
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 05/22/2017
Notes: All medical devices
76 - - - -- Dental
Date Published: 05/22/2017
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 05/22/2017
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 05/22/2017
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 05/22/2017
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 05/22/2017
Notes: All medical devices
84 - - - -- Neurological
Date Published: 05/22/2017
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 05/22/2017
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 05/22/2017
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 05/22/2017
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 05/22/2017
Notes: All medical devices
90 - - - -- Radiology
Date Published: 05/22/2017
Notes: All medical devices
Homedics China
Date Published : 09/16/2009
Shi Da Road , Liangbianguanli Liaobuzhen
, Dongguan,
Guangdong CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: All Device 8/22/2008
Update 2/5/2009; *CDRH indicates Blood Pressure Monitors (74D-XN) and Electric Massagers
(89I-SA) are not subject to DWPE under this Import Alert
76 - - - -- Dental
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: All Device 8/22/2008 ;Update 2/5/2009; *CDRH indicates Blood Pressure Monitors (74D-XN) and Electric Massagers (89I-SA) are not subject to DWPE under this Import Alert
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: All devices ; 8/22/08
JIANGSU BAIDE MEDICAL INSTRUMENT CO.,LTD.
Date Published : 04/02/2018
No.29,North Guotai Road,Ecomomic&Technological Development , South Side Of Dongqi Road
, Zhangjiagang,
Jiangsu CHINA
73 - - - -- Anesthesiology
Date Published: 04/03/2018
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 04/03/2018
Notes: All medical devices
76 - - - -- Dental
Date Published: 04/03/2018
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 04/03/2018
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 04/03/2018
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 04/03/2018
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 04/03/2018
Notes: All medical devices
84 - - - -- Neurological
Date Published: 04/03/2018
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 04/03/2018
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 04/03/2018
Notes: All medical devices
87 H - - RS Plate, Fixation, Bone
Date Published: 04/02/2018
Desc: Interlocking Plate System (K150009)
87 H - - WC Screw, Fixation, Bone
Date Published: 04/02/2018
Desc: Interlocking Plate System (K150009)
87 - - - -- Orthopedic
Date Published: 04/03/2018
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 04/03/2018
Notes: All medical devices
90 - - - -- Radiology
Date Published: 04/03/2018
Notes: All medical devices
Jiangsu Angel Medical Instrument Co., Ltd.
Date Published : 04/07/2017
168 Jinyanghe Road , Zhangjiagang
, Suzhou,
Jiangsu CHINA
73 - - - -- Anesthesiology
Date Published: 04/07/2017
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 04/07/2017
Notes: All medical devices
76 - - - -- Dental
Date Published: 04/07/2017
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 04/07/2017
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 04/07/2017
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 04/07/2017
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 04/07/2017
Notes: All medical devices
84 - - - -- Neurological
Date Published: 04/07/2017
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 04/07/2017
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 04/07/2017
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 04/07/2017
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 04/07/2017
Notes: All medical devices
90 - - - -- Radiology
Date Published: 04/07/2017
Notes: All medical devices
Jiangsu Caina Medical Co., Ltd
Date Published : 04/03/2024
No. 23 Huan West Rd , Zhutangzhen Jiangyin
, Wuxi,
Jiangsu CHINA
80 F - - MF Syringe, Piston
Date Published: 04/03/2024
Desc: Piston Syringes
Notes: ALL Human Use and Veterinary Use Piston Syringes
Jiangsu Ideal Medical Science & Technology Co. Ltd.
Date Published : 04/10/2018
East Area, Jinfeng Industry Park
, Zhangjiagang,
Jiangsu CHINA
73 - - - -- Anesthesiology
Date Published: 04/10/2018
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 04/10/2018
Notes: All medical devices
76 - - - -- Dental
Date Published: 04/10/2018
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 04/10/2018
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 04/10/2018
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 04/10/2018
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 04/10/2018
Notes: All medical devices
84 - - - -- Neurological
Date Published: 04/10/2018
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 04/10/2018
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 04/10/2018
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 04/10/2018
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 04/10/2018
Notes: All medical devices
90 - - - -- Radiology
Date Published: 04/10/2018
Notes: All medical devices
Jiangsu Shenli Medical Production Co., Ltd.
Date Published : 04/10/2024
No. 20 Changzheng Road , Zhengluzhen Wujin
, Changzhou,
Jiangsu CHINA
78 P - - NR Enteral Syringes with enteral specific connectors
Date Published: 07/16/2024
Desc: Enteral Syringes With Enteral Specific Connectors
Notes:
80 F - - MF Syringe, Piston
Date Published: 04/10/2024
Desc: All Piston Syringes
Notes: All piston syringes from this firm are subject to DWPE under this import alert
Jiangsu Tong Zhou City Weaving Factory
Date Published : 09/16/2009
Xing Ren Town
, Tong Zhou City,
CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices. 3/3/1995
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Jiangyan Medical Products Factory
Date Published : 09/16/2009
Baoqu, Jinagyan
, Taizhou,
Jiangsu CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 6/9/1997
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Kwonnie Electrical Products Limited
Date Published : 09/16/2009
3rd Industrial Estate , Qingxi
, Dongguan Guangdong,
CHINA
76 J - - EQ Toothbrush, Powered
Date Published: 09/16/2009
Notes: 2/20/08
89 I - - MC Bath, Paraffin
Date Published: 09/16/2009
Notes: 2/20/2008
NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD.
Date Published : 08/14/2012
JIANGSHAN TOWN , YINZHOU SECTION
, NINGBO,
CHINA
74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive
Date Published: 08/14/2012
Desc: Blood Pressure Monitor
74 O - - FE Central venous blood pressure kit
Date Published: 08/14/2012
Desc: Blood Pressure Monitor
80 F - - LK Thermometer, Clinical Mercury
Date Published: 08/14/2012
Desc: Mercury Thermometer
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 08/14/2012
Desc: Clinical Electronic Thermometer
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 08/14/2012
Desc: Infrared Thermometer
Nantong City Xin Kai Weaving Factory
Date Published : 09/16/2009
Zhao Yang Road
, Nantong City,
Jiangsu CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 3/14/1995
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Ningbo Textiles Imp And Exp Corp
Date Published : 09/16/2009
188 South Jie Fang Road
, Ningbo,
CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 10/25/2001
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Rossmax (Shanghai) Inc., Ltd.
Date Published : 09/16/2009
No. 6018 Huyi Highway , Jiading
, Shanghai,
Shanghai CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All Devices. 5/27/08.
AKA Rossmax Shanghai International
AKA Rossmax Medical
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD.
Date Published : 09/16/2009
No. 36 , Fengxian District
, Shanghai,
Shanghai CHINA
80 F - - MC Glove, Patient Examination
Date Published: 02/23/2024
Desc: All Latex Examination and Surgeon's Gloves (Sterile and Non-sterile)
Notes: 1/25/1996
80 K - - GO Surgeon's Gloves
Date Published: 02/23/2024
Desc: All Latex Examination and Surgeons Gloves (Sterile and Non-sterile)
Notes: 1/25/1996
80 L - - YY Glove, Patient Examination, Latex
Date Published: 02/23/2024
Desc: All Latex Examination and Surgeon's Gloves (Sterile and Non-sterile)
Notes: 1/25/1996
80 O - - IG Rubber examination gloves, powder-free
Date Published: 02/23/2024
Desc: All Latex Examination and Surgeons Gloves (Sterile and Non-sterile)
Notes: 1/25/1996
Shandong Zibo Shanchuan Medical Instrument Co. Ltd.
Date Published : 01/20/2012
No. 88 Shanchuan Road; Chengnan Town Zichuan District
, Zibo,
Shandong CHINA
80 F - - MF Syringe, Piston
Date Published: 01/20/2012
Desc: Piston Syringe (Sterile) Piston Syringes; Hipodermic Needle Insulin Syringe (Sterile)
80 F - - MI Needle, Hypodermic, Single Lumen
Date Published: 01/20/2012
Desc: Piston Syringe (Sterile) Piston Syringes; Hipodermic Needle Insulin Syringe (Sterile)
Shandong Zibo Shanchuan Medical Instrument Co. Ltd.
Date Published : 10/23/2012
No. 88 Shanchuan Road; Chengnan Town Zichuan District
, Zibo,
Shandong CHINA
80 F - - MF Syringe, Piston
Date Published: 10/23/2012
Desc: Piston Syringe Sterile; Piston Syringes; Hypodermic Needles; Insulin Syringe Sterile ;
80 F - - MI Needle, Hypodermic, Single Lumen
Date Published: 10/23/2012
Desc: Piston Syringe Sterile; Piston Syringes; Hypodermic Needles; Insulin Syringe Sterile ;
Shanghai Kindly Enterprise Development Group Co., Ltd
Date Published : 05/16/2024
No. 658 Gaochao Road
, Jiading,
Shanghai CHINA
80 F - - MF Syringe, Piston
Date Published: 05/16/2024
Desc: All Piston Syringes
Shanghai Lord International Trade Co., Ltd.
Date Published : 09/16/2009
Rm. C, Floor 22, Zhi Yuan Bldg., , No. 768 Xie Tu Road
, Shanghai,
CHINA
74 D - - XQ Cuff, Blood-Pressure
Date Published: 02/14/2019
Desc: Sphygmomanometers
Notes: 5/26/2009
Shanghai Ruike Sports Goods Co., LTD.
Date Published : 03/10/2016
No. 518 Baopan Road
, Shanghai,
Shanghai CHINA
89 I - - NI Vehicle, Motorized 3-Wheeled
Date Published: 03/10/2016
Desc: Motorized Scooters
Notes: Models 331 and 3431
Sinochem Ningbo Latex Gloves
Date Published : 09/16/2009
Hua Lian Bldg. Floor 11-12 , 21 Jiangxia Street
, Ningbo,
CHINA
73 - - - -- Anesthesiology
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
74 - - - -- Cardiovascular
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
76 - - - -- Dental
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
77 - - - -- Ear,Nose And Throat
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
78 - - - -- Gastroenterological & Urological
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
79 - - - -- General & Plastic Surgery
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
80 - - - -- General Hospital/Personal Use
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001;
Exempt Patient Examination Gloves; Product code: 80LYY, 80LZA, 80LZC, 80LYZ, 80FMC; 11/14/2001
84 - - - -- Neurological
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
85 - - - -- Obstetrical & Gynecological
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
86 - - - -- Ophthalmic
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
87 - - - -- Orthopedic
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
89 - - - -- Physical Medicine
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
90 - - - -- Radiology
Date Published: 02/06/2019
Notes: All Medical Devices ; 11/14/2001
Suzhou Du Fa Medical Dressing Factory
Date Published : 09/16/2009
No 9-1 Inside Road South Gate
, Suzhou,
Jiangsu CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All medical devices from Zhang Jia Gang City Medica Cloth Factory #2 5/02/1995
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Suzhou Gemmed Medical Instrument Co. Ltd.
Date Published : 04/10/2018
A22&26 Science & Technology Development , Jinfeng Town ; Jinnan Rd; Zhangjiagang
, Suzhou,
Jiangsu CHINA
73 - - - -- Anesthesiology
Date Published: 04/10/2018
Notes: All medical devices;
74 - - - -- Cardiovascular
Date Published: 04/10/2018
Notes: All medical devices;
76 - - - -- Dental
Date Published: 04/10/2018
Notes: All medical devices;
77 - - - -- Ear,Nose And Throat
Date Published: 04/10/2018
Notes: All medical devices;
78 - - - -- Gastroenterological & Urological
Date Published: 04/10/2018
Notes: All medical devices;
79 - - - -- General & Plastic Surgery
Date Published: 04/10/2018
Notes: All medical devices;
80 - - - -- General Hospital/Personal Use
Date Published: 04/10/2018
Notes: All medical devices;
84 - - - -- Neurological
Date Published: 04/10/2018
Notes: All medical devices;
85 - - - -- Obstetrical & Gynecological
Date Published: 04/10/2018
Notes: All medical devices;
86 - - - -- Ophthalmic
Date Published: 04/10/2018
Notes: All medical devices;
87 - - - -- Orthopedic
Date Published: 04/10/2018
Notes: All medical devices;
89 - - - -- Physical Medicine
Date Published: 04/10/2018
Notes: All medical devices;
90 - - - -- Radiology
Date Published: 04/10/2018
Notes: All medical devices;
Teamedics (Taishan) Manufacturing Co., Ltd.
Date Published : 09/16/2009
Hang Chen Industrial Area, Qian Jing Lu , Xi Xiang Town, Zone #112
, Shezhen,
CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 2/27/2008
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Teamedics Manufacturing
Date Published : 09/16/2009
Block 6/13, He Dong Industrial Village
, Xin An Town Bao An Country Shenzhen,
CHINA
73 - - - -- Anesthesiology
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
74 - - - -- Cardiovascular
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
76 - - - -- Dental
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
77 - - - -- Ear,Nose And Throat
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
78 - - - -- Gastroenterological & Urological
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
79 - - - -- General & Plastic Surgery
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
80 - - - -- General Hospital/Personal Use
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
84 - - - -- Neurological
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
85 - - - -- Obstetrical & Gynecological
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
86 - - - -- Ophthalmic
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
87 - - - -- Orthopedic
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
89 - - - -- Physical Medicine
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
90 - - - -- Radiology
Date Published: 02/06/2019
Notes: All Devices; 3/3/2008
Textus Ningbo Manufacturing Co., Ltd.
Date Published : 09/16/2009
Baidu , Fenghua
, Ningbo,
Zhejiang CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices. 8/4/2000
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Tianjin Bolang Science-Technology Development Co., Ltd.
Date Published : 07/22/2021
High-Tech Green Industry Base , D-401; Industrial Area
, Hua Yuan,
Tianjin CHINA
73 - - - -- Anesthesiology
Date Published: 07/22/2021
Notes: All Medical Devices
74 - - - -- Cardiovascular
Date Published: 07/22/2021
Notes: All Medical Devices
76 - - - -- Dental
Date Published: 07/22/2021
Notes: All Medical Devices
77 - - - -- Ear,Nose And Throat
Date Published: 07/22/2021
Notes: All Medical Devices
78 - - - -- Gastroenterological & Urological
Date Published: 07/22/2021
Notes: All Medical Devices
79 - - - -- General & Plastic Surgery
Date Published: 07/22/2021
Notes: All Medical Devices
80 - - - -- General Hospital/Personal Use
Date Published: 07/22/2021
Notes: All Medical Devices
84 - - - -- Neurological
Date Published: 07/22/2021
Notes: All Medical Devices
85 - - - -- Obstetrical & Gynecological
Date Published: 07/22/2021
Notes: All Medical Devices
86 - - - -- Ophthalmic
Date Published: 07/22/2021
Notes: All Medical Devices
87 - - - -- Orthopedic
Date Published: 07/22/2021
Notes: All Medical Devices
89 - - - -- Physical Medicine
Date Published: 07/22/2021
Notes: All Medical Devices
90 - - - -- Radiology
Date Published: 07/22/2021
Notes: All Medical Devices
Tong Zhou City Medical
Date Published : 09/16/2009
Health Factory #2 , Heng Gang Town East
, Tong Zhou,
Jiangsu CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 3/3/1995
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Wenzhou Hongshun Industries and Trade Co.
Date Published : 09/16/2009
No 801, 8/F Bldg 5 north Zone, 2 Phase , Nature Garden Wenzhou
, Zhejiang,
CHINA
74 D - - XQ Cuff, Blood-Pressure
Date Published: 09/16/2009
Notes: 5/26/2009
Xiantao Tongda Non-woven Products Co., Ltd.
Date Published : 01/06/2016
South Of Xiansha Road , Peng Changzhen Xiantao
, Huanggang,
Hubei CHINA
73 - - - -- Anesthesiology
Date Published: 01/06/2016
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 01/06/2016
Notes: All medical devices
76 - - - -- Dental
Date Published: 01/06/2016
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 01/06/2016
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 01/06/2016
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 01/06/2016
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 01/06/2016
Notes: All medical devices
84 - - - -- Neurological
Date Published: 01/06/2016
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 01/06/2016
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 01/06/2016
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 01/06/2016
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 01/06/2016
Notes: All medical devices
90 - - - -- Radiology
Date Published: 01/06/2016
Notes: All medical devices
Xue Xia Health Products
Date Published : 09/16/2009
Gaobu Town , Shaoxing
, Shaoxing,
Zhejiang CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All medical deviced 3/3/1995
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Zhang Jia Gang City Medical Cloth Factory #2
Date Published : 09/16/2009
Gaoqiao Houcheng Township , Jingangzhen Zhangjiagang
, Suzhou,
Jiangsu CHINA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All medical devices GPI-DE 5/02/1995
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
DENMARK
Faaborg Rehab Technic Aps
Date Published : 09/16/2009
Smedemestervej 9
, Faaborg,
Syddanmark DENMARK
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 10/21/2004
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
FRANCE
Alseal
Date Published : 12/08/2016
2 rue Professeur Paul Milleret
, Besancon,
Doubs FRANCE
74 D - - YB Introducer, Catheter
Date Published: 12/08/2016
Desc: Catheter Introducer
Bio Ms
Date Published : 09/16/2009
Parc D'Activites Pau Pyrenees
, Pau,
FRANCE
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 4/26/1993
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Kontron Instruments Sa
Date Published : 09/16/2009
2 Avenue Due Manet
, Montigny,
FRANCE
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 6/25/1992
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Poly Implant Protheses, S.A.
Date Published : 09/16/2009
337 Avenue De Bruxelles
, La Seyne Sur Mer,
VAR FRANCE
79 F - - WM Prosthesis, Breast, Inflatable, Internal, Saline
Date Published: 09/16/2009
Notes: 10/28/2005
Saint Gobain Ceramiques Avancees Desmarquest
Date Published : 09/16/2009
Z.I. No. 1, Rue De L'Industrie
, Evreux,
FRANCE
87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
Date Published: 09/16/2009
Notes: Ziconia Ceremic Femoral Head. 7/9/2002
Schiller Medical
Date Published : 09/16/2009
4 Rue Louis Pasteur
, Wissembourg,
Bas-Rhin FRANCE
74 D - - RK Dc-Defibrillator, High Energy, (Including Paddles)
Date Published: 09/16/2009
74 L - - DD Dc-Defibrillator, Low-Energy, (Including Paddles)
Date Published: 09/16/2009
74 L - - WS Defibrillator, Automatic Implantable Cardioverter
Date Published: 09/16/2009
74 M - - KJ Automated external defibrillators (non-wearable)
Date Published: 09/16/2009
Sebbin Laboratories
Date Published : 02/14/2019
62 Rue Saint Martin
, Pontoise,
Val d'Oise FRANCE
79 F - - TR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Date Published: 02/14/2019
Desc: Breast Implants
Notes: 10/2/1990
79 F - - WM Prosthesis, Breast, Inflatable, Internal, Saline
Date Published: 02/14/2019
Desc: Breast Implants
Notes: 10/2/1990
Telectronics Sa
Date Published : 09/16/2009
11 Rue Andre Charles Boulle
, Chatellerault,
Vienne FRANCE
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 11/5/1993
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
GERMANY
Biodynamics International
Date Published : 09/16/2009
Industriestrasse 6 , D-91077
, Neunkerchen,
GERMANY
73 - - - -- Anesthesiology
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994
74 - - - -- Cardiovascular
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
76 - - - -- Dental
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
77 - - - -- Ear,Nose And Throat
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
78 - - - -- Gastroenterological & Urological
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
79 - - - -- General & Plastic Surgery
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
80 - - - -- General Hospital/Personal Use
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
84 - - - -- Neurological
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
85 - - - -- Obstetrical & Gynecological
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
86 - - - -- Ophthalmic
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
87 - - - -- Orthopedic
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
89 - - - -- Physical Medicine
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
90 - - - -- Radiology
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
Biodynamics International (Corp offices)
Date Published : 09/16/2009
Langemarckplatz 3
, Erlangen,
Bavaria GERMANY
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: "Tutoplast Dura" (Dura Mater) All models/lots, including 68006, 68007, 68013,
68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112. 5/5/1994
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Biodynamics International (Deutchland) GmbH
Date Published : 09/16/2009
Postfach 1243
, Erlangen,
Bavaria GERMANY
73 - - - -- Anesthesiology
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
74 - - - -- Cardiovascular
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
76 - - - -- Dental
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
77 - - - -- Ear,Nose And Throat
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
78 - - - -- Gastroenterological & Urological
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
79 - - - -- General & Plastic Surgery
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
80 - - - -- General Hospital/Personal Use
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
84 - - - -- Neurological
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
85 - - - -- Obstetrical & Gynecological
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
86 - - - -- Ophthalmic
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
87 - - - -- Orthopedic
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
89 - - - -- Physical Medicine
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
90 - - - -- Radiology
Date Published: 01/29/2019
Notes: Tutoplast Dura (Dura Mater); All models/lots including 68006, 68007, 68013, 68065, 68005, 68001, 68009, 68004, 68002, 68111, 68112; 5/05/1994 ;
Dewe and Company
Date Published : 09/16/2009
Verbandstoff-Fabrik Dr D-6532
, Wermelskirchen,
GERMANY
79 K - - GX Tape And Bandage, Adhesive
Date Published: 09/16/2009
Notes: 8/29/1994
MERCK, GMBH
Date Published : 02/13/2019
PHILIPP-REISS STRASSE 8/13 , D-61273
, DARMSTADT,
GERMANY
87 L - - OD Bone Cement
Date Published: 02/13/2019
Desc: All Bone Cements
Notes: Distributor; 1/9/1998
Mela Gmbh Elektromedizin
Date Published : 09/16/2009
Schatzbogen 38
, Munich,
Bavaria GERMANY
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Serag-Wiessner Gmbh
Date Published : 09/16/2009
Zum Kugelfang
, Naila,
GERMANY
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All sterile devices for veterinary use.
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Spiegelberg Gmbh & Co. KG
Date Published : 08/23/2016
Tempowerkring 4
, Hamburg,
Hamburg GERMANY
73 - - - -- Anesthesiology
Date Published: 08/23/2016
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 08/23/2016
Notes: All medical devices
76 - - - -- Dental
Date Published: 08/23/2016
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2016
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 08/23/2016
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 08/23/2016
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 08/23/2016
Notes: All medical devices
84 - - - -- Neurological
Date Published: 08/23/2016
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 08/23/2016
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 08/23/2016
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 08/23/2016
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 08/23/2016
Notes: All medical devices
90 - - - -- Radiology
Date Published: 08/23/2016
Notes: All medical devices
HONG KONG SAR
Teamedics Manufacturing Co Ltd
Date Published : 09/16/2009
22/F , Corporation Park Block A
, Sha Tin,
New Territories HONG KONG SAR
73 - - - -- Anesthesiology
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
74 - - - -- Cardiovascular
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
76 - - - -- Dental
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
77 - - - -- Ear,Nose And Throat
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
78 - - - -- Gastroenterological & Urological
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
79 - - - -- General & Plastic Surgery
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
80 - - - -- General Hospital/Personal Use
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
84 - - - -- Neurological
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
85 - - - -- Obstetrical & Gynecological
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
86 - - - -- Ophthalmic
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
87 - - - -- Orthopedic
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
89 - - - -- Physical Medicine
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
90 - - - -- Radiology
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
Teamedics Manufacturing Co. Ltd.
Date Published : 09/16/2009
St. Paul's Cathloic Day Nursery , 212 Wan Tau Street
, Tai Po,
New Territories HONG KONG SAR
73 - - - -- Anesthesiology
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
74 - - - -- Cardiovascular
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
76 - - - -- Dental
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
77 - - - -- Ear,Nose And Throat
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
78 - - - -- Gastroenterological & Urological
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
79 - - - -- General & Plastic Surgery
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
80 - - - -- General Hospital/Personal Use
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
84 - - - -- Neurological
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
85 - - - -- Obstetrical & Gynecological
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
86 - - - -- Ophthalmic
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
87 - - - -- Orthopedic
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
89 - - - -- Physical Medicine
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
90 - - - -- Radiology
Date Published: 02/06/2019
Notes: All Devices ; 3/3/2008
HUNGARY
MANDELAY KFT
Date Published : 03/09/2020
Huba Utca 25-2
, Tokol,
Pest HUNGARY
73 - - - -- Anesthesiology
Date Published: 03/09/2020
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 03/09/2020
Notes: All medical devices
76 - - - -- Dental
Date Published: 03/09/2020
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 03/09/2020
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 03/09/2020
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 03/09/2020
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 03/09/2020
Notes: All medical devices
84 - - - -- Neurological
Date Published: 03/09/2020
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 03/09/2020
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 03/09/2020
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 03/09/2020
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 03/09/2020
Notes: All medical devices
90 - - - -- Radiology
Date Published: 03/09/2020
Notes: All medical devices
INDIA
RFB Gloves
Date Published : 09/16/2009
78-80 Noida Special Economic Zone , Sdf No. C-08(C)
, Noida, Uttar Pradesh,
INDIA
79 K - - GO Surgeon's Gloves
Date Published: 09/16/2009
Notes: Sterile Latex Surgical & Examination Gloves; 9/8/1999
80 F - - MC Glove, Patient Examination
Date Published: 09/16/2009
Notes: Sterile Latex Surgical & Examination Gloves; 9/8/1999
80 L - - YY Glove, Patient Examination, Latex
Date Published: 09/16/2009
Notes: Sterile Latex Surgical & Examination Gloves; 9/8/1999
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 09/16/2009
Notes: Sterile Latex Surgical & Examination Gloves; 9/8/1999
80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 09/16/2009
Notes: Sterile Latex Surgical & Examination Gloves; 9/8/1999
Vinyas Innovative Technologies Pvt., Ltd.
Date Published : 01/12/2015
KIADB Plot No. 19, Sy. No. 26 & 273-P , Koorgally Industrial Area
, Mysore,
Karnataka INDIA
73 - - - -- Anesthesiology
Date Published: 01/12/2015
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 01/12/2015
Notes: All medical devices
76 - - - -- Dental
Date Published: 01/12/2015
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 01/12/2015
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 01/12/2015
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 01/12/2015
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 01/12/2015
Notes: All medical devices
84 - - - -- Neurological
Date Published: 01/12/2015
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 01/12/2015
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 01/12/2015
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 01/12/2015
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 01/12/2015
Notes: All medical devices
90 - - - -- Radiology
Date Published: 01/12/2015
Notes: All medical devices
INDONESIA
P T Gotong Rojong Djaja
Date Published : 09/16/2009
29, 31, 33, Jalan Hindu
, Medan,
INDONESIA
80 F - - MC Glove, Patient Examination
Date Published: 09/16/2009
Notes: Patient Examination Gloves; Class I; 6/5/1996
80 L - - YY Glove, Patient Examination, Latex
Date Published: 09/16/2009
Notes: Patient Examination Gloves; Class I; 6/5/1996
P.T. Saptindo Surgica
Date Published : 09/16/2009
Jl, Raya Serang Km 65 , Cikande Serang
, Jawa Barat,
INDONESIA
80 K - - GO Surgeon's Gloves
Date Published: 03/12/2021
Desc: Surgeon's Gloves
Notes: 9/22/1999
Pt. Krisna Mulia Nusantara
Date Published : 09/16/2009
P.O. Box 1396 Jat
, Jakarta,
INDONESIA
80 K - - ZH Introducer, Syringe Needle
Date Published: 09/16/2009
Notes: 3/26/1996
IRELAND
Amicon Ireland, Ltd.
Date Published : 09/16/2009
Raheen
, Limerick,
Co. CLARE IRELAND
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices)
2/8/1995
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
75 - - - -- Chemistry
Date Published: 01/29/2019
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
76 - - - -- Dental
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
81 - - - -- Hematology
Date Published: 01/29/2019
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
82 - - - -- Immunology
Date Published: 01/29/2019
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
83 - - - -- Microbiology
Date Published: 01/29/2019
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
88 - - - -- Pathology
Date Published: 01/29/2019
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
91 - - - -- Toxicology
Date Published: 01/29/2019
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
92 - - - -- Molecular Genetics
Date Published: 01/29/2019
Notes: Sterile Hemofiluer and other devices (EXCEPT In-Vitro Diagnostic Devices) 2/8/1995
Virtus, Ltd.
Date Published : 09/16/2009
Adamstown, Lucan Co.
, Dublin,
IRELAND
74 J - - OW Sleeve, Limb, Compressible
Date Published: 09/16/2009
Notes: 10/19/2000
ISRAEL
Hi-Tec Implants
Date Published : 09/16/2009
5 Maskit Street , Industrial Zone
, Herzlia,
ISRAEL
76 D - - ZE Implant, Endosseous
Date Published: 09/16/2009
Notes: Smooth Fit Dental Implants 5/1/1997
ITALY
Flametal S.P.A.
Date Published : 09/16/2009
Via G. Di Vittorio 51
, Fornovo Di Taro,
PR ITALY
Micromeccanica Di Bianchi Lucia
Date Published : 09/16/2009
Via Petrarca, 17
, Ceriano Laghetto,
MI ITALY
76 D - - ZE Implant, Endosseous
Date Published: 02/13/2019
Desc: Hydroxyapatitic Endosseous (Dental Implants)
Notes: 8/24/1999
RIMOS SRL
Date Published : 08/14/2012
VIA MANUZIO 15
, Mirandola,
Modena ITALY
73 - - - -- Anesthesiology
Date Published: 08/14/2012
74 - - - -- Cardiovascular
Date Published: 08/14/2012
76 - - - -- Dental
Date Published: 08/14/2012
77 - - - -- Ear,Nose And Throat
Date Published: 08/14/2012
78 - - - -- Gastroenterological & Urological
Date Published: 08/14/2012
79 - - - -- General & Plastic Surgery
Date Published: 08/14/2012
80 - - - -- General Hospital/Personal Use
Date Published: 08/14/2012
84 - - - -- Neurological
Date Published: 08/14/2012
85 - - - -- Obstetrical & Gynecological
Date Published: 08/14/2012
86 - - - -- Ophthalmic
Date Published: 08/14/2012
87 - - - -- Orthopedic
Date Published: 08/14/2012
89 - - - -- Physical Medicine
Date Published: 08/14/2012
90 - - - -- Radiology
Date Published: 08/14/2012
STERIL MILANO S.R.L. - REGGIOLO
Date Published : 05/24/2021
Via Giovanni Caboto 38-40
, Reggiolo,
Reggio Emilia ITALY
73 - - - -- Anesthesiology
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
74 - - - -- Cardiovascular
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
76 - - - -- Dental
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
77 - - - -- Ear,Nose And Throat
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
78 - - - -- Gastroenterological & Urological
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
79 - - - -- General & Plastic Surgery
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
80 - - - -- General Hospital/Personal Use
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
84 - - - -- Neurological
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
85 - - - -- Obstetrical & Gynecological
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
86 - - - -- Ophthalmic
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
87 - - - -- Orthopedic
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
89 - - - -- Physical Medicine
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
90 - - - -- Radiology
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
STERIL MILANO, SRL
Date Published : 05/24/2021
Via Pompei 6
, Monza,
Monza E della Brianza ITALY
73 - - - -- Anesthesiology
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
74 - - - -- Cardiovascular
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
76 - - - -- Dental
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
77 - - - -- Ear,Nose And Throat
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
78 - - - -- Gastroenterological & Urological
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
79 - - - -- General & Plastic Surgery
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
80 - - - -- General Hospital/Personal Use
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
84 - - - -- Neurological
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
85 - - - -- Obstetrical & Gynecological
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
86 - - - -- Ophthalmic
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
87 - - - -- Orthopedic
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
89 - - - -- Physical Medicine
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
90 - - - -- Radiology
Date Published: 05/24/2021
Notes: Ethylene Oxide (ETO) Sterilized Medical Devices;
All Ethylene oxide (ETO) Sterilized Medical Devices
Sclavo Diagnostics SRL
Date Published : 09/16/2009
Unknown
, Rosia,
ITALY
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
75 - - - -- Chemistry
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
76 - - - -- Dental
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
81 - - - -- Hematology
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
82 - - - -- Immunology
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
83 - - - -- Microbiology
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
88 - - - -- Pathology
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
91 - - - -- Toxicology
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
92 - - - -- Molecular Genetics
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
Sclavo Diagnostics SRL
Date Published : 09/16/2009
Via Fiorentina 1
, Siena,
SI ITALY
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
75 - - - -- Chemistry
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
76 - - - -- Dental
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
81 - - - -- Hematology
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
82 - - - -- Immunology
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
83 - - - -- Microbiology
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
88 - - - -- Pathology
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: All Devices; 3/2/1993
91 - - - -- Toxicology
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
92 - - - -- Molecular Genetics
Date Published: 02/05/2019
Notes: All Devices; 3/2/1993
Sclavo Spa
Date Published : 02/20/2019
Via Fiorentina 1
, Siena,
Siena ITALY
73 - - - -- Anesthesiology
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
74 - - - -- Cardiovascular
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
75 - - - -- Chemistry
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
76 - - - -- Dental
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
77 - - - -- Ear,Nose And Throat
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
78 - - - -- Gastroenterological & Urological
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
79 - - - -- General & Plastic Surgery
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
80 - - - -- General Hospital/Personal Use
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
81 - - - -- Hematology
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
82 - - - -- Immunology
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
83 - - - -- Microbiology
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
84 - - - -- Neurological
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
85 - - - -- Obstetrical & Gynecological
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
86 - - - -- Ophthalmic
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
87 - - - -- Orthopedic
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
88 - - - -- Pathology
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
89 - - - -- Physical Medicine
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
90 - - - -- Radiology
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
91 - - - -- Toxicology
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
92 - - - -- Molecular Genetics
Date Published: 02/20/2019
Notes: All Devices; 3/2/1993
JAPAN
Ishikawa Manufactory Co., Ltd.
Date Published : 09/16/2009
1647 Ohashi
, Dano,
JAPAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices.
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Izumo Health Co., Ltd.
Date Published : 09/16/2009
Nanaki 6057 , Ohaza
, Higashichikumagun,
JAPAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: 8/5/1993
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: 8/5/1993
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: 8/5/1993
Mackie 3M Specialties
Date Published : 09/16/2009
1 Chome 30-5 , Yanagibashi
, Taito,
Tokyo JAPAN
74 D - - RK Dc-Defibrillator, High Energy, (Including Paddles)
Date Published: 09/16/2009
Notes: 6/3/1993
74 L - - DD Dc-Defibrillator, Low-Energy, (Including Paddles)
Date Published: 09/16/2009
Notes: 6/3/1993
74 L - - WS Defibrillator, Automatic Implantable Cardioverter
Date Published: 09/16/2009
Notes: 6/3/1993
NEC San-Ei Instruments, Ltd.
Date Published : 09/16/2009
1-57 Tecjin-Cho
, Kodaira City,
Tokyo JAPAN
74 D - - RK Dc-Defibrillator, High Energy, (Including Paddles)
Date Published: 09/16/2009
Notes: 6/3/1993
74 L - - DD Dc-Defibrillator, Low-Energy, (Including Paddles)
Date Published: 09/16/2009
Notes: 6/3/1993
74 L - - WS Defibrillator, Automatic Implantable Cardioverter
Date Published: 09/16/2009
Notes: 6/3/1993
NEC Tochigi, Ltd
Date Published : 09/16/2009
484 Harigaya-Cho
, Utsunohiya City,
Tochigi Pref. JAPAN
74 D - - RK Dc-Defibrillator, High Energy, (Including Paddles)
Date Published: 09/16/2009
Notes: 6/3/1993
74 L - - DD Dc-Defibrillator, Low-Energy, (Including Paddles)
Date Published: 09/16/2009
Notes: 6/3/1993
74 L - - WS Defibrillator, Automatic Implantable Cardioverter
Date Published: 09/16/2009
Notes: 6/3/1993
Sanden Medical Co.,Ltd.
Date Published : 09/18/2013
6 17 9 Shikahama , Adachi-Ku,
, Adachi-ku,
Tokyo-to JAPAN
74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive
Date Published: 09/18/2013
Desc: Aneroid Sphygmomanometers
KOREA (THE REPUBLIC OF)
Boin Medica Co., Ltd.
Date Published : 09/16/2009
293 Gongdan - Dong
, Kumi City, Kyungbuk,
KOREA (THE REPUBLIC OF)
80 F - - MF Syringe, Piston
Date Published: 09/16/2009
Notes: Disposable syringes Sterile. Class II. 7/31/1995
Dong Bang Medical Supplies Corporation
Date Published : 09/16/2009
5-27 Shin Kong Dok-Dong , Mapo-Ku
, Seoul,
KOREA (THE REPUBLIC OF)
80 F - - MF Syringe, Piston
Date Published: 09/16/2009
Notes: Sterile Disposable Syringes; 3/21/1996
Kyungwon Medical Co., Ltd.
Date Published : 01/07/2013
765, Jeongjungyeonje-ro
, Osong-eup,
Chungcheongbuk-do KOREA (THE REPUBLIC OF)
84 G - - XP Methyl Metacrylate For Cranioplasty
Date Published: 01/07/2013
Desc: Polybone bone substitue
87 M - - NH Orthosis, Spondyloisthesis Spinal Fixation
Date Published: 01/07/2013
Desc: Tyche pedicle screw fixation system
Philosys Co. Ltd
Date Published : 09/21/2020
28-5 Gwangwol-Gil , Okgu-Eup
, Gunsan,
Jeonrabuk KOREA (THE REPUBLIC OF)
75 C - - GA Glucose Oxidase, Glucose
Date Published: 09/21/2020
Desc: Gmate Voice Blood Glucose Monitoring System
75 C - - GA Glucose Oxidase, Glucose
Date Published: 09/21/2020
Desc: Gmate Test Strips
75 C - - GA Glucose Oxidase, Glucose
Date Published: 09/21/2020
Desc: Gmate Smart (iOS) Blood Glucose Monitoring System
75 C - - GA Glucose Oxidase, Glucose
Date Published: 09/21/2020
Desc: Gmate (Step) Mini Blood Glucose Monitoring System
75 C - - GA Glucose Oxidase, Glucose
Date Published: 09/21/2020
Desc: Gmate Smart (Android) Blood Glucose Monitoring System
75 C - - GA Glucose Oxidase, Glucose
Date Published: 09/21/2020
Desc: Gmate Origin Blood Glucose Monitoring System
75 C - - GA Glucose Oxidase, Glucose
Date Published: 09/21/2020
Desc: GlucoTrack Test Strips
75 C - - GA Glucose Oxidase, Glucose
Date Published: 09/21/2020
Desc: Gmate Step Blood Glucose Monitoring System
75 N - - BW System, Test, Blood Glucose, Over the Counter
Date Published: 09/21/2020
Desc: GlucoTrack Test Strips
75 N - - BW System, Test, Blood Glucose, Over the Counter
Date Published: 09/21/2020
Desc: Gmate Smart (iOS) Blood Glucose Monitoring System
75 N - - BW System, Test, Blood Glucose, Over the Counter
Date Published: 09/21/2020
Desc: Gmate Origin Blood Glucose Monitoring System
75 N - - BW System, Test, Blood Glucose, Over the Counter
Date Published: 09/21/2020
Desc: Gmate Voice Blood Glucose Monitoring System
75 N - - BW System, Test, Blood Glucose, Over the Counter
Date Published: 09/21/2020
Desc: Gmate Test Strips
75 N - - BW System, Test, Blood Glucose, Over the Counter
Date Published: 09/21/2020
Desc: Gmate Step Blood Glucose Monitoring System
75 N - - BW System, Test, Blood Glucose, Over the Counter
Date Published: 09/21/2020
Desc: Gmate Smart (Android) Blood Glucose Monitoring System
75 N - - BW System, Test, Blood Glucose, Over the Counter
Date Published: 09/21/2020
Desc: Gmate (Step) Mini Blood Glucose Monitoring System
Sam Woo Corporation Ltd
Date Published : 09/16/2009
231-6 Kuk Jul-Ri , Jungnam-Myun Kwasung-Gun
, Kyounggi-Do,
KOREA (THE REPUBLIC OF)
80 F - - MF Syringe, Piston
Date Published: 09/16/2009
Notes: Syringes; disposable
80 F - - MI Needle, Hypodermic, Single Lumen
Date Published: 09/16/2009
Notes: Disposable needles (14-27 gauge) 80 F MI 5/23/01
Sometech Incorporated
Date Published : 08/25/2011
2f, Byuksan Digital Valley Iii , 212-13, Gurodong, Guro-Ku
, Seoul,
KOREA (THE REPUBLIC OF)
73 - - - -- Anesthesiology
Date Published: 08/25/2011
Notes: All devices
74 - - - -- Cardiovascular
Date Published: 08/25/2011
Notes: All devices
76 - - - -- Dental
Date Published: 08/25/2011
Notes: All devices
77 - - - -- Ear,Nose And Throat
Date Published: 08/25/2011
Notes: All devices
78 - - - -- Gastroenterological & Urological
Date Published: 08/25/2011
Notes: All devices
79 - - - -- General & Plastic Surgery
Date Published: 08/25/2011
Notes: All devices
80 - - - -- General Hospital/Personal Use
Date Published: 08/25/2011
Notes: All devices
84 - - - -- Neurological
Date Published: 08/25/2011
Notes: All devices
85 - - - -- Obstetrical & Gynecological
Date Published: 08/25/2011
Notes: All devices
86 - - - -- Ophthalmic
Date Published: 08/25/2011
Notes: All devices
87 - - - -- Orthopedic
Date Published: 08/25/2011
Notes: All devices
89 - - - -- Physical Medicine
Date Published: 08/25/2011
Notes: All devices
90 - - - -- Radiology
Date Published: 08/25/2011
Notes: All devices
Won Industry Co. LTD
Date Published : 09/25/2019
Wonsaneop , 7-12 Bangadari-Gil
, Siheung,
Gyeonggi KOREA (THE REPUBLIC OF)
73 - - - -- Anesthesiology
Date Published: 09/25/2019
Notes: All Devices
74 - - - -- Cardiovascular
Date Published: 09/25/2019
Notes: All Devices
76 - - - -- Dental
Date Published: 09/25/2019
Notes: All Devices
77 - - - -- Ear,Nose And Throat
Date Published: 09/25/2019
Notes: All Devices
78 - - - -- Gastroenterological & Urological
Date Published: 09/25/2019
Notes: All Devices
79 - - - -- General & Plastic Surgery
Date Published: 09/25/2019
Notes: All Devices
80 - - - -- General Hospital/Personal Use
Date Published: 09/25/2019
Notes: All Devices
84 - - - -- Neurological
Date Published: 09/25/2019
Notes: All Devices
85 - - - -- Obstetrical & Gynecological
Date Published: 09/25/2019
Notes: All Devices
86 - - - -- Ophthalmic
Date Published: 09/25/2019
Notes: All Devices
87 - - - -- Orthopedic
Date Published: 09/25/2019
Notes: All Devices
89 - - - -- Physical Medicine
Date Published: 09/25/2019
Notes: All Devices
90 - - - -- Radiology
Date Published: 09/25/2019
Notes: All Devices
MALAYSIA
Alang Bidara Industries Sdn Bhd
Date Published : 09/16/2009
Lot 2574 , Kampong Olak Lempit
, Banting, Selangor,
MALAYSIA
80 F - - MC Glove, Patient Examination
Date Published: 09/16/2009
Notes: 9/4/1996
80 L - - YY Glove, Patient Examination, Latex
Date Published: 09/16/2009
Notes: 9/4/1996
Cranberry (M) Sdn Bhd
Date Published : 09/16/2009
Lot 85
, Ipoh,
Perak MALAYSIA
79 K - - GO Surgeon's Gloves
Date Published: 09/16/2009
Notes: 1/6/2000
80 F - - MC Glove, Patient Examination
Date Published: 09/16/2009
Notes: 1/6/2000
80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 09/16/2009
Notes: 1/6/2000
Dongkuk Techco Rubber Ind. Sdn Bhd
Date Published : 02/01/2019
7th Floor Mayban Trust Bldg , 3 Pehang Street
, Penang 10200,
MALAYSIA
73 - - - -- Anesthesiology
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
74 - - - -- Cardiovascular
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
76 - - - -- Dental
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
77 - - - -- Ear,Nose And Throat
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
78 - - - -- Gastroenterological & Urological
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
79 - - - -- General & Plastic Surgery
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
80 - - - -- General Hospital/Personal Use
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
84 - - - -- Neurological
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
86 - - - -- Ophthalmic
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
87 - - - -- Orthopedic
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
89 - - - -- Physical Medicine
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
90 - - - -- Radiology
Date Published: 02/01/2019
Notes: All Devices; 3/11/2009
Dongkuk Techco Rubber Industries Sdn. Bhd.
Date Published : 09/16/2009
Sungai Petani
, Sungai Petani,
Kedah MALAYSIA
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
76 - - - -- Dental
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
85 H - - IS Condom
Date Published: 02/01/2019
Desc: Condoms and other rubber medical devices
Notes: 11/08/1991
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: All devices. GPI = DE 3/11/2009
Rj Medical Products (M) Sdn Bhd
Date Published : 09/16/2009
Lot 723 , Batu 5 1/2, Jalan Kapar
, Klang,
MALAYSIA
80 L - - YY Glove, Patient Examination, Latex
Date Published: 09/16/2009
Notes: 2/1/1999
Sime Healthcare Sdn Bhd
Date Published : 09/16/2009
65-66 Senawang Ind Est
, Negeri Sembilan,
MALAYSIA
85 H - - IS Condom
Date Published: 09/16/2009
Notes: 11/21/1995
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes: 11/21/1995
MEXICO
Covidien
Date Published : 09/16/2009
Boulevard De Los Insurgentes 19030 , Col. Libramiento, Tijuana
, Tijuana,
Baja California MEXICO
73 C - - CK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Date Published: 09/16/2009
Notes: 4/6/2005, CapnoProbe SLS Sublingual CO2 Sensor (K010795)
DeGasa, S.A. de C.V.
Date Published : 09/16/2009
Calle Avenida Prolongacion Canal De Miramontes # 3775 , Col. Los Colorines, Tlalpan
, Ciudad De Mexico,
Ciudad de Mexico MEXICO
73 - - - -- Anesthesiology
Date Published: 04/27/2012
Notes: All sterile medical devices
74 - - - -- Cardiovascular
Date Published: 04/27/2012
Notes: All sterile medical devices
76 - - - -- Dental
Date Published: 04/27/2012
Notes: All sterile medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 04/27/2012
Notes: All sterile medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 04/27/2012
Notes: All sterile medical devices
79 - - - -- General & Plastic Surgery
Date Published: 04/27/2012
Notes: All sterile medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 04/27/2012
Notes: All sterile medical devices
84 - - - -- Neurological
Date Published: 04/27/2012
Notes: All sterile medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 04/27/2012
Notes: All sterile medical devices
86 - - - -- Ophthalmic
Date Published: 04/27/2012
Notes: All sterile medical devices
87 - - - -- Orthopedic
Date Published: 04/27/2012
Notes: All sterile medical devices
89 - - - -- Physical Medicine
Date Published: 04/27/2012
Notes: All sterile medical devices
90 - - - -- Radiology
Date Published: 04/27/2012
Notes: All sterile medical devices
Derivados De Gasa, Sa De Cv
Date Published : 02/01/2019
Calle Henry Ford No 366 , Col. Bondojito, Gustavo A. Madero
, Ciudad De Mexico,
Ciudad de Mexico MEXICO
73 - - - -- Anesthesiology
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
74 - - - -- Cardiovascular
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
75 - - - -- Chemistry
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
76 - - - -- Dental
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
77 - - - -- Ear,Nose And Throat
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
78 - - - -- Gastroenterological & Urological
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
79 - - - -- General & Plastic Surgery
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
80 - - - -- General Hospital/Personal Use
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
81 - - - -- Hematology
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
82 - - - -- Immunology
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
83 - - - -- Microbiology
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
84 - - - -- Neurological
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
85 - - - -- Obstetrical & Gynecological
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
86 - - - -- Ophthalmic
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
87 - - - -- Orthopedic
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
88 - - - -- Pathology
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
89 - - - -- Physical Medicine
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
90 - - - -- Radiology
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
91 - - - -- Toxicology
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
92 - - - -- Molecular Genetics
Date Published: 02/01/2019
Notes: All Devices; 3/9/1994
Guantes Quirurgicos S A de C V
Date Published : 09/16/2009
Av Centenario No 15 , 62500 Civac Jiutepec
, Cuernavaca,
Moreles MEXICO
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 3/9/1994
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
75 - - - -- Chemistry
Date Published: 02/05/2019
Notes: All devices 3/9/1994 ;
76 - - - -- Dental
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
81 - - - -- Hematology
Date Published: 02/05/2019
Notes: All devices 3/9/1994 ;
82 - - - -- Immunology
Date Published: 02/05/2019
Notes: All devices 3/9/1994 ;
83 - - - -- Microbiology
Date Published: 02/05/2019
Notes: All devices 3/9/1994 ;
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
88 - - - -- Pathology
Date Published: 02/05/2019
Notes: All devices 3/9/1994 ;
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: All devices 3/9/1994 ;
91 - - - -- Toxicology
Date Published: 02/05/2019
Notes: All devices 3/9/1994 ;
92 - - - -- Molecular Genetics
Date Published: 02/05/2019
Notes: All devices 3/9/1994 ;
Supertex Industrial, S.A. de C.V.
Date Published : 09/16/2009
Carretera A Bosques De San Isidro # 1136
, Zapopan,
Jalisco MEXICO
80 F - - MC Glove, Patient Examination
Date Published: 09/16/2009
Notes: Examination Gloves; 1/25/1999
80 L - - YY Glove, Patient Examination, Latex
Date Published: 09/16/2009
Notes: Examination Gloves; 1/25/1999
NETHERLANDS
European Medical Contract Mfg.
Date Published : 09/16/2009
Middenkampweg 17
, Nijmegen,
Gelderland NETHERLANDS
84 M - - LQ Inhibitor, Peridural Fibrosis (Adhesion Barrier)
Date Published: 03/11/2021
Desc: Adcon-L
Future Diagnostics Solutions B.V.
Date Published : 11/21/2024
Nieuweweg 279
, Wijchen,
Gelderland NETHERLANDS
75 - - - -- Chemistry
Date Published: 11/21/2024
Desc: All Devices
Gliatech EMCM Bv
Date Published : 09/16/2009
Gerstweg 2
, Nijmegen,
Gelderland NETHERLANDS
84 M - - LQ Inhibitor, Peridural Fibrosis (Adhesion Barrier)
Date Published: 03/11/2021
Desc: ADCON-L Anti-Adhesion Barrier
Notes: 11/3/1999; Update 12/12/2001
Gliatech Inc (E.M.C.M. Bv)
Date Published : 09/16/2009
Middenkampweg 17
, Nijmegen,
Gelderland NETHERLANDS
84 M - - LQ Inhibitor, Peridural Fibrosis (Adhesion Barrier)
Date Published: 03/11/2021
Desc: ADCON-L Anti-Adhesion Barrier
Notes: 11/3/1999; Update 12/12/2001
Orthoton BV
Date Published : 09/16/2009
Avelingen-West 27c
, Gorinchem,
Zuid-Holland NETHERLANDS
76 D - - ZB Headgear, Extraoral, Orthodontic
Date Published: 09/16/2009
Notes: T-Gear. 7/19/2004
PAKISTAN
Alframed Corp.
Date Published : 09/16/2009
72-C-Industrial Estate
, Sialkot,
PAKISTAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices GPI=DE 6/8/05
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Ess Zee Industries
Date Published : 09/16/2009
Roras Road
, Sialkot,
PAKISTAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: 9/23/2004
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Everbright Industries, Ltd.
Date Published : 09/16/2009
P.O. Box 336
, Sialkot,
PAKISTAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
75 - - - -- Chemistry
Date Published: 02/05/2019
Notes: All devices including stainless steel surgical instruments; 5/20/1994
76 - - - -- Dental
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
81 - - - -- Hematology
Date Published: 02/05/2019
Notes: All devices including stainless steel surgical instruments; 5/20/1994
82 - - - -- Immunology
Date Published: 02/05/2019
Notes: All devices including stainless steel surgical instruments; 5/20/1994
83 - - - -- Microbiology
Date Published: 02/05/2019
Notes: All devices including stainless steel surgical instruments; 5/20/1994
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
88 - - - -- Pathology
Date Published: 02/05/2019
Notes: All devices including stainless steel surgical instruments; 5/20/1994
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments; 5/20/1994
91 - - - -- Toxicology
Date Published: 02/05/2019
Notes: All devices including stainless steel surgical instruments; 5/20/1994
92 - - - -- Molecular Genetics
Date Published: 02/05/2019
Notes: All devices including stainless steel surgical instruments; 5/20/1994
Muhkam Trading Corporporation
Date Published : 09/16/2009
Anwar Khawaja Road Near Wapda Grid Sta. , P.O. Box 850
, Sialkot,
Punjab PAKISTAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 9/23/2004
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Subhani Surgical Corp.
Date Published : 09/16/2009
Mohllallah Naya Miani Pura Chah Sayan , P O BOX 821
, Sialkot,
PAKISTAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
75 - - - -- Chemistry
Date Published: 02/06/2019
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
76 - - - -- Dental
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
81 - - - -- Hematology
Date Published: 02/06/2019
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
82 - - - -- Immunology
Date Published: 02/06/2019
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
83 - - - -- Microbiology
Date Published: 02/06/2019
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
88 - - - -- Pathology
Date Published: 02/06/2019
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
91 - - - -- Toxicology
Date Published: 02/06/2019
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
92 - - - -- Molecular Genetics
Date Published: 02/06/2019
Notes: All devices including stainless steel surgical instruments.; 5/25/1994
PERU
Cirugia S.A.
Date Published : 09/16/2009
Avenida Maquinarias 2414
, Lima,
Lima PERU
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 8/9/2005
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 G - - AK Suture, Absorbable
Date Published: 09/16/2009
Notes: 7/21/2000
79 G - - AO Suture, Nonabsorbable
Date Published: 09/16/2009
Notes: 7/21/2000
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
PHILIPPINES
C WORLD KSG CORPORATION
Date Published : 11/02/2016
NO 2 8th Street Golden Mile Business Par
, Cavite,
Calabarzon PHILIPPINES
73 - - - -- Anesthesiology
Date Published: 11/02/2016
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 11/02/2016
Notes: All medical devices
76 - - - -- Dental
Date Published: 11/02/2016
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 11/02/2016
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 11/02/2016
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 11/02/2016
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 11/02/2016
Notes: All medical devices
84 - - - -- Neurological
Date Published: 11/02/2016
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 11/02/2016
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 11/02/2016
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 11/02/2016
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 11/02/2016
Notes: All medical devices
90 - - - -- Radiology
Date Published: 11/02/2016
Notes: All medical devices
SPAIN
Global Medical Technology SL
Date Published : 02/16/2023
Nave 51 , Calle Isla Alegranza 2
, San Sebastian de los Reyes,
Madrid SPAIN
79 O - - NF Powered light based non-laser surgical instrument with thermal effect
Date Published: 02/16/2023
Desc: Platinum Medical IPL System
IDEMSA
Date Published : 09/16/2009
Nicodedes Garcia
, Segovia,
SPAIN
81 K - - HG Whole Blood Hemoglobin Determination
Date Published: 09/16/2009
Notes: 5/2/1995
Knickerbocker Laboratories
Date Published : 09/16/2009
Calle Comte Borrell 158
, Barcelona,
Barcelona SPAIN
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this
revision with specific concern for the firms VDRL Antigen) 5/16/1995
74 - - - -- Cardiovascular
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this
revision with specific concern for the firms VDRL Antigen) 5/16/1995
75 - - - -- Chemistry
Date Published: 02/05/2019
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
76 - - - -- Dental
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
81 - - - -- Hematology
Date Published: 02/05/2019
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
82 - - - -- Immunology
Date Published: 02/05/2019
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
83 - - - -- Microbiology
Date Published: 02/05/2019
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
84 - - - -- Neurological
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
86 - - - -- Ophthalmic
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
87 - - - -- Orthopedic
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
88 - - - -- Pathology
Date Published: 02/05/2019
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
90 - - - -- Radiology
Date Published: 09/16/2009
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
91 - - - -- Toxicology
Date Published: 02/05/2019
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
92 - - - -- Molecular Genetics
Date Published: 02/05/2019
Notes: All in vitro devices (CDRH has requested all devices be included under this revision with specific concern for the firms VDRL Antigen) 5/16/1995
Madespa S.A.
Date Published : 09/16/2009
Calle Jarama 120
, Toledo,
Toledo SPAIN
76 D - - ZS Capsule, Dental, Amalgam
Date Published: 09/16/2009
Notes: 11/11/2008
76 E - - BD Coating, Filling Material, Resin
Date Published: 09/16/2009
Notes: 11/11/2008
76 E - - BI Resin, Denture, Relining, Repairing, Rebasing
Date Published: 09/16/2009
Notes: 11/11/2008
76 E - - MA Cement, Dental
Date Published: 09/16/2009
Notes: 11/11/2008
SWITZERLAND
Argomedical
Date Published : 09/16/2009
Gewerbestrasse 5
, Cham,
Zug SWITZERLAND
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 12/17/2004
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
DJO GLOBAL SWITZERLAND SARL
Date Published : 01/30/2019
ZI Larges Pieces A , Chemin du Devent
, Ecublens,
Vaud SWITZERLAND
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 01/30/2019
Desc: Compex 2 Nerve; Transcutaneous
Notes: 3/02/1999
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 01/30/2019
Desc: Compex 2 Iontophoresis
Notes: 3/02/1999
89 I - - PF Stimulator, Muscle, Powered
Date Published: 01/30/2019
Desc: Compex 2 Muscle Stimulator
Notes: 3/02/1999
Rubimed AG
Date Published : 05/08/2013
Grossmatt 3
, Hergiswil Nw,
Nidwalden SWITZERLAND
84 H - - CC Device, Biofeedback
Date Published: 05/08/2013
Desc: REBA biofeedback device
TAIWAN
BroadMaster Biotech Corp.
Date Published : 09/12/2023
Zhongli District , 1 F.; 2f., No.91, Xiyuan Road
, Taoyuan City,
Taoyuan TAIWAN
73 - - - -- Anesthesiology
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
74 - - - -- Cardiovascular
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
75 - - - -- Chemistry
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
76 - - - -- Dental
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
77 - - - -- Ear,Nose And Throat
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
78 - - - -- Gastroenterological & Urological
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
79 - - - -- General & Plastic Surgery
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
80 - - - -- General Hospital/Personal Use
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
81 - - - -- Hematology
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
82 - - - -- Immunology
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
83 - - - -- Microbiology
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
84 - - - -- Neurological
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
85 - - - -- Obstetrical & Gynecological
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
86 - - - -- Ophthalmic
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
87 - - - -- Orthopedic
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
88 - - - -- Pathology
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
89 - - - -- Physical Medicine
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
90 - - - -- Radiology
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
91 - - - -- Toxicology
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
92 - - - -- Molecular Genetics
Date Published: 09/12/2023
Notes: All Devices and Diagnostics; Veterinary Use Devices are not subject to DWPE under this Import Alert.
E-Care Technology Corp.
Date Published : 04/20/2020
8f-11, No. 35, Hsin-Tai Rd.
, Chubei City,
Hsinchu District TAIWAN
80 F - - LL Thermometer, Electronic, Clinical
Date Published: 04/20/2020
Desc: Infrared Thermometers
Honyee Enterprise Co.
Date Published : 09/16/2009
No. 166-20, Riao-Pu-Li , Box 46-464, Cosmos Bldg, Matou Chen
, Tai-nan,
Taipei TAIWAN
80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 09/16/2009
Notes: Powdered and non-sterile. 11/12/1996
Linsure Industries, Ltd.
Date Published : 02/05/2019
No 56 Wu Chuan 3rd Rd , Wu Ku Industrial Area
, Taipei,
TAIWAN
80 F - - MW Cover, Mattress (Medical Purposes)
Date Published: 02/05/2019
Desc: All alternating pressure mattress systems
Notes: 01/31/1996
80 F - - NM Mattress, Air Flotation, Alternating Pressure
Date Published: 02/05/2019
Desc: All alternating pressure mattress systems
Notes: 01/31/1996
80 F - - OH Mattress, Water, Temperature Regulated
Date Published: 02/05/2019
Desc: All alternating pressure mattress systems
Notes: 01/31/1996
80 I - - KY Mattress, Flotation Therapy, Non-Powered
Date Published: 02/05/2019
Desc: All alternating pressure mattress systems
Notes: 01/31/1996
Rossmax International Ltd.
Date Published : 09/16/2009
12F, No. 189, Kang Chien Road
, Taipei,
TAIWAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: All devices 5/27/2008
aka Rossmax Innotek
aka Rossmax Medical
aka Rossmax Taiwan International
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Taiwan Fuji Latex Co., Ltd.
Date Published : 09/16/2009
Tamshui Zhen 46-3 , Pi-Dao Li
, Taipei Hsien,
TAIWAN
85 H - - IS Condom
Date Published: 09/16/2009
Notes: Condoms; 9/14/2000
85 L - - TZ Condom With Nonoxynol-9
Date Published: 02/15/2019
Desc: Condoms
Notes: 9/14/2000
Wan Shou Rubber Industrial Corp Ltd.
Date Published : 09/16/2009
No 11 Sha Ta An
, Taichung,
TAIWAN
80 K - - GO Surgeon's Gloves
Date Published: 03/17/2021
Desc: Surgeon's Gloves
Notes: 1/23/1996
THAILAND
C. Rubber Co., Ltd.
Date Published : 09/16/2009
162/2 Noo 4, Petchkasane Road, Omnon
, Kratumban,
THAILAND
80 L - - YY Glove, Patient Examination, Latex
Date Published: 09/16/2009
Notes: 11/12/1996
DAH Lee Rubber Industries, Ltd.
Date Published : 01/31/2019
1 , 5; Soi Polpichai Rd Rd Niphutsongkraw
, Hat Yai,
Songkhla THAILAND
80 L - - YY Glove, Patient Examination, Latex
Date Published: 01/31/2019
Desc: Latex Non-Sterile Powdered and Powder Free Medical Exam Gloves
Notes: Class II - 3/6/1996
Mri Co., Ltd.
Date Published : 09/16/2009
314/316 Section 5 , Surasak
, Sriracha, Chonburri,
THAILAND
79 K - - GO Surgeon's Gloves
Date Published: 09/16/2009
Notes: 3/14/1995
80 F - - MC Glove, Patient Examination
Date Published: 09/16/2009
Notes: 3/14/1995
80 L - - YY Glove, Patient Examination, Latex
Date Published: 09/16/2009
Notes: 3/14/1995
80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 09/16/2009
Notes: 3/14/1995
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 09/16/2009
Notes: 3/14/1995
80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 09/16/2009
Notes: 3/14/1995
Royal King Infant Products Co., Ltd.
Date Published : 10/09/2012
73/4 Moo 1 Khaelie , Krathumbaen
, Samutsakhon,
THAILAND
52 E - - 99 Infant Food Items, n.e.c.
Date Published: 10/10/2012
Desc: Fluid-Filled Teething Rings ;
53 A - - 99 Other Baby Products, N.E.C.
Date Published: 10/10/2012
Desc: Fluid-Filled Teething Rings ;
54 E - - 04 Camomille (Herbal & Botanical Teas)
Date Published: 10/10/2012
Desc: Fluid-Filled Teething Rings ;
76 K - - KO Ring, Teething, Fluid-Filled
Date Published: 10/09/2012
Desc: Fluid-Filled Teething Rings
76 M - - EF Ring, Teething, Non-Fluid Filled
Date Published: 10/10/2012
Desc: Fluid-Filled Teething Rings ;
UNITED KINGDOM
APC Medical, Ltd.
Date Published : 09/16/2009
68 Tewin Rd
, Welwyn Garden City,
Hertfordshire UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: all medical devices 10/28/2002
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Arjo Med. AB
Date Published : 09/16/2009
St. Catherine Street
, Gloucester,
UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: all devices 2/11/2005
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Berwickshire Electronic Manufacturing Ltd.
Date Published : 02/26/2016
Unit G Industrial Estate, Station Road , Industrial Estate; Station Road
, Duns,
Berwickshire UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 02/26/2016
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 02/26/2016
Notes: All medical devices
76 - - - -- Dental
Date Published: 02/26/2016
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 02/26/2016
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 02/26/2016
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 02/26/2016
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 02/26/2016
Notes: All medical devices
84 - - - -- Neurological
Date Published: 02/26/2016
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 02/26/2016
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 02/26/2016
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 02/26/2016
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 02/26/2016
Notes: All medical devices
90 - - - -- Radiology
Date Published: 02/26/2016
Notes: All medical devices
Biosil, Ltd.
Date Published : 09/16/2009
127 Deerdykes View , Westfield Ind Estate
, Glasgow,
UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: all devices 5/23/2000
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009
Central Surgical Co. Ltd.
Date Published : 08/24/2013
82a-84a Citizen Road
, London,
UNITED KINGDOM
85 M - - QE Needle, Assisted Reproduction
Date Published: 08/24/2013
Desc: Oocyte Aspiration Needles
GAELTEC DEVICES LTD
Date Published : 08/14/2018
Dunvegan Fire Station , Glendale Road
, Isle Of Skye,
HLD UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 08/14/2018
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 08/14/2018
Notes: All medical devices
76 - - - -- Dental
Date Published: 08/14/2018
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 08/14/2018
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 08/14/2018
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 08/14/2018
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 08/14/2018
Notes: All medical devices
84 - - - -- Neurological
Date Published: 08/14/2018
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 08/14/2018
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 08/14/2018
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 08/14/2018
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 08/14/2018
Notes: All medical devices
90 - - - -- Radiology
Date Published: 08/14/2018
Notes: All medical devices
Implants International Ltd.
Date Published : 03/09/2016
71 Jay Avenue
, Thornaby-On-Tees,
North Riding of Yorkshire UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 03/09/2016
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 03/09/2016
Notes: All medical devices
76 - - - -- Dental
Date Published: 03/09/2016
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 03/09/2016
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 03/09/2016
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 03/09/2016
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 03/09/2016
Notes: All medical devices
84 - - - -- Neurological
Date Published: 03/09/2016
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 03/09/2016
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 03/09/2016
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 03/09/2016
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 03/09/2016
Notes: All medical devices
90 - - - -- Radiology
Date Published: 03/09/2016
Notes: All medical devices
J & J Special Products
Date Published : 09/16/2009
Unit 9B, Clive Works, Edward Street
, Redditch,
Worcestershire UNITED KINGDOM
79 H - - MN Suture, Nonabsorable, Ophthalmic
Date Published: 09/16/2009
Notes: 9/7/1995
79 H - - MO Suture, Absorbable, Ophthalmic
Date Published: 09/16/2009
Notes: 9/7/1995
Medical Industrial Equipment
Date Published : 09/16/2009
Liverton Business Park , Salterton Road, Exmouth
, Devon,
Devon UNITED KINGDOM
73 B - - SZ Gas Machine, Anesthesia
Date Published: 09/16/2009
Notes: 6/13/2000
Omega Laser Systems
Date Published : 03/07/2016
Unit 2 , Deans Hall Business Park; Oak Road
, Halstead,
Essex UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 03/07/2016
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 03/07/2016
Notes: All medical devices
76 - - - -- Dental
Date Published: 03/07/2016
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 03/07/2016
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 03/07/2016
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 03/07/2016
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 03/07/2016
Notes: All medical devices
84 - - - -- Neurological
Date Published: 03/07/2016
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 03/07/2016
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 03/07/2016
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 03/07/2016
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 03/07/2016
Notes: All medical devices
90 - - - -- Radiology
Date Published: 03/07/2016
Notes: All medical devices
Orthodesign Ltd
Date Published : 02/05/2019
Unit 19 Sea Vixen Industrial Estate , Wilverley Road
, Christchurch,
Dorset UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
74 - - - -- Cardiovascular
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
76 - - - -- Dental
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
77 - - - -- Ear,Nose And Throat
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
78 - - - -- Gastroenterological & Urological
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
79 - - - -- General & Plastic Surgery
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
80 - - - -- General Hospital/Personal Use
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
84 - - - -- Neurological
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
85 - - - -- Obstetrical & Gynecological
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
86 - - - -- Ophthalmic
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
87 - - - -- Orthopedic
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
89 - - - -- Physical Medicine
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
90 - - - -- Radiology
Date Published: 02/05/2019
Notes: Titanium Dental Implants; 1/20/1995
Puretone Ltd.
Date Published : 09/16/2009
Unit 9-10 , Henley Business Park; Trident Close
, Rochester,
Kent UNITED KINGDOM
77 E - - SD Hearing-Aid, Air-Conduction
Date Published: 09/16/2009
Notes: 5/26/2009
77 K - - LW Masker, Tinnitis
Date Published: 09/16/2009
Notes: 5/26/2009
Smiths Medical International Ltd.
Date Published : 09/16/2009
Colonial Way
, Watford,
UNITED KINGDOM
80 F - - RN Pump, Infusion
Date Published: 09/16/2009
Notes: 6/19/2006
80 M - - EA Pump, Infusion, Pca
Date Published: 09/16/2009
Notes: 6/19/2006
Sutures Ltd.
Date Published : 09/16/2009
Vauxhall Industrial Estate
, Wrexham,
UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 09/16/2009
Notes: absorbable and non-absorbale surgical sutures
74 - - - -- Cardiovascular
Date Published: 09/16/2009
76 - - - -- Dental
Date Published: 09/16/2009
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009
84 - - - -- Neurological
Date Published: 09/16/2009
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009
86 - - - -- Ophthalmic
Date Published: 09/16/2009
87 - - - -- Orthopedic
Date Published: 09/16/2009
89 - - - -- Physical Medicine
Date Published: 09/16/2009
90 - - - -- Radiology
Date Published: 09/16/2009