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: 06/13/2019
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: The revisions to this import alert dated 10/29/2015 updates the title to be more accurate, and updates the CDRH Import Branch phone number. Changes are bracketed by asterisks (***).

NOTE: The revisions to this import alert dated 10/8/2014 updates the CDRH Import Branch name and contact information, updates contact information for the Office of Regulatory Science and provides additional information on the removal process. Changes are bracketed by asterisks (***).

The revision of this Import Alert, dated 02/25/13 adds information indicating that inspections conducted by foreign or other government inspecting authorities can be a basis for DWPE and guidance on how to remove a firm and product from this alert, and modifies the charge to more closely track the statutory language. Changes are bracketed with asterisks (***).

Foreign inspections 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).

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:

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

Foreign manufacturers listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions and/or practices that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation.

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

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

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

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

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

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

Or
via email: Importalerts2@fda.hhs.gov ***

Product Description:

All medical devices

COUNTRY: All Countries

FIRMS: See Red List



PROBLEM: Failure to Meet Device Good Manufacturing Practices (GMP's)

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) of the FD&C Act]."

OASIS Charge
Code: DEVICE GMPS

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 Freyre 1635 , 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 - - - -- Radiological
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 CHIEFLY DRIVE , 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 - - - -- Radiological
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 - - - -- Radiological
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

EUROMI S.A.
Date Published : 06/22/2018
Z. I. de Lambermont , Rue des Ormes 151 , Lambermont, Liege BELGIUM
73 - - - -- Anesthesiology
Date Published: 06/22/2018

Notes: All medical devices

74 - - - -- Cardiovascular
Date Published: 06/22/2018

Notes: All medical devices

76 - - - -- Dental
Date Published: 06/22/2018

Notes: All medical devices

77 - - - -- Ear,Nose And Throat
Date Published: 06/22/2018

Notes: All medical devices

78 - - - -- Gastroenterological & Urological
Date Published: 06/22/2018

Notes: All medical devices

79 - - - -- General & Plastic Surgery
Date Published: 06/22/2018

Notes: All medical devices

80 - - - -- General Hospital/Personal Use
Date Published: 06/22/2018

Notes: All medical devices

84 - - - -- Neurological
Date Published: 06/22/2018

Notes: All medical devices

85 - - - -- Obstetrical & Gynecological
Date Published: 06/22/2018

Notes: All medical devices

86 - - - -- Ophthalmic
Date Published: 06/22/2018

Notes: All medical devices

87 - - - -- Orthopedic
Date Published: 06/22/2018

Notes: All medical devices

89 - - - -- Physical Medicine
Date Published: 06/22/2018

Notes: All medical devices

90 - - - -- Radiological
Date Published: 06/22/2018

Notes: All medical devices


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 - - - -- Radiological
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, PE 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
Four Winds Way , Mississauga, 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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 09/16/2009

Cardiomed Supplies, Inc.
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

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

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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
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

Starplex Scientific
Date Published : 09/16/2009
50 Steinway Blvd , Etobicoke, 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 - - - -- Radiological
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

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 - - - -- Radiological
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 , Beijingshi, Beijingshi 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 - - - -- Radiological
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 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: Digital Thermometers

80 F - - LL Thermometer, Electronic, Clinical
Date Published: 05/18/2017

Desc: Rectal Thermometers

80 F - - LL Thermometer, Electronic, Clinical
Date Published: 05/18/2017

Desc: Infrared Ear Thermometers

Guilin Zizhu Latex Co., Ltd
Date Published : 08/25/2015
NO. 6 Wushanlu , Guilin City, 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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 05/22/2017

Notes: All medical devices

Homedics China
Date Published : 09/16/2009
Liaobu Liangbian Cun , Industrial Zone , 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 - - - -- Radiological
Date Published: 09/16/2009

Notes: All devices ; 8/22/08

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 - - - -- Radiological
Date Published: 04/07/2017

Notes: All medical devices

Jiangsu BaiDe Medical Instrument Co., Ltd.
Date Published : 04/02/2018
South Side Of Dongqi Road , Zhangjiagang , Suzhou, 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 - - - -- Radiological
Date Published: 04/03/2018

Notes: All medical devices

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 - - - -- Radiological
Date Published: 04/10/2018

Notes: All medical devices

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

Rossmax (Shanghai) Inc., Ltd.
Date Published : 09/16/2009
No 6018 Huyilu , Waigang, Jiading , Shanghaishi, Shanghaishi 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 - - - -- Radiological
Date Published: 09/16/2009

SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD.
Date Published : 09/16/2009
NO. 36,LEIZHOU ROAD, XINGHUO DEVELOPMENT , FENGXIAN DISTRICT , SHANGHAI, SHANGHAI CHINA
79 K - - GO Surgeon's Gloves
Date Published: 09/16/2009

Notes: 1/25/1996

80 F - - MC Glove, Patient Examination
Date Published: 09/16/2009

Notes: 1/25/1996

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

Notes: 1/25/1996

Shandong Zibo Shanchuan Medical Instrument Co. Ltd.
Date Published : 01/20/2012
88 Shanchuan Road , Zichuan, Chengnan Town , 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
88 Shanchuan Road , Zichuan, Chengnan Town , 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 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 Lu , Shanghai City, Shanghaishi 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
21 Jiangxia Street, 11-12 Floor , Hua Lian Bldg. , 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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 09/16/2009

Suzhou Gemmed Medical Instrument Co. Ltd.
Date Published : 04/10/2018
A22&26 Science & Technology Development , Jinfeng Twon ; Jinnanlu; 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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 02/06/2019

Notes: All Devices; 3/3/2008

Textus Ningbo Manufacturing Co., Ltd.
Date Published : 09/16/2009
Baidu, Fenghua City , 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 - - - -- Radiological
Date Published: 09/16/2009

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 - - - -- Radiological
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 , Pengchang Town , Xiantao, 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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 09/16/2009

Zhang Jia Gang City Medical Cloth Factory #2
Date Published : 09/16/2009
Gaoqiao Houcheng Township , Zhang Jia Gang City, Jiangsu Province 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 - - - -- Radiological
Date Published: 09/16/2009


DENMARK


Faaborg Rehab Technic Aps
Date Published : 09/16/2009
Smedemestervej 9 , Faaborg, 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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 09/16/2009

Poly Implant Protheses, S.A.
Date Published : 09/16/2009
337 Avenue De Bruxelles , La Seyne Sur Mer, 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, 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, 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 - - - -- Radiological
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 - - - -- Radiological
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
Langmarckplatz 3 , Erlangen, 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 - - - -- Radiological
Date Published: 09/16/2009

Biodynamics International (Deutchland) GmbH
Date Published : 09/16/2009
Postfach 1243 , Erlangen, 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 - - - -- Radiological
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, 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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 08/23/2016

Notes: All medical devices


HONG KONG


Teamedics Manufacturing Co Ltd
Date Published : 09/16/2009
22/F Block A Corporation Park , 11 On Lai Street, Siu Lek Yuen , Shatin, HONG KONG
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 - - - -- Radiological
Date Published: 02/06/2019

Notes: All Devices ; 3/3/2008

Teamedics Manufacturing Co. Ltd.
Date Published : 09/16/2009
212 Au Pui Wan Street , Shantin, HONG KONG
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 - - - -- Radiological
Date Published: 02/06/2019

Notes: All Devices ; 3/3/2008


INDIA


RFB Latex (Private) Ltd.
Date Published : 09/16/2009
Plot 24, Noida Export Processing Zone , Noida-Dadri Rd., Phase II, Dist. T , Gautam Budh Nagar, Utar 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 - - - -- Radiological
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
Km. 65 , Jl Raya Serang , Serang, Banten INDONESIA
79 K - - GO Surgeon's Gloves
Date Published: 09/16/2009

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 - - - -- Radiological
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


Diffuplast SRL
Date Published : 09/16/2009
Via Piave 48 , Olgiate Olona, VA ITALY
78 K - - NT Tubes, Gastrointestinal (And Accessories)
Date Published: 09/16/2009

Notes: 8/14/2001

80 K - - PE Container, I.V.
Date Published: 09/16/2009

Notes: 8/14/2001

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

RI. MOS S.R.L.
Date Published : 08/14/2012
Viale Gramsci, N.29 , Mirandola, MO 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 - - - -- Radiological
Date Published: 08/14/2012

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 - - - -- Radiological
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
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 - - - -- Radiological
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
V Fiorentina 1 , Siena Si, 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 - - - -- Radiological
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 - - - -- Radiological
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

Kawamoto Corporation
Date Published : 09/16/2009
2 Chome 4-1 Kawaraya-Machi , Chuo; Kawaraya-Machi; Chuo , Osaka, Osaka JAPAN
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: All sterile medical devices product code DE 11/29/1995

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

Mackie 3M Specialties
Date Published : 09/16/2009
30-5 Yanagibashi 1-Chome , Taito-Ku, 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, REPUBLIC OF (SOUTH)


Boin Medica Co., Ltd.
Date Published : 09/16/2009
293 Gongdan - Dong , Kumi City, Kyungbuk, KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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

Nuga Medical Co., Ltd.
Date Published : 01/22/2015
185 Jiraeul-ro , Jijeong-myeon , Weonju-si, Gangweon-do KOREA, REPUBLIC OF (SOUTH)
73 - - - -- Anesthesiology
Date Published: 01/22/2015

Notes: All Medical Devices

74 - - - -- Cardiovascular
Date Published: 01/22/2015

Notes: All Medical Devices

76 - - - -- Dental
Date Published: 01/22/2015

Notes: All Medical Devices

77 - - - -- Ear,Nose And Throat
Date Published: 01/22/2015

Notes: All Medical Devices

78 - - - -- Gastroenterological & Urological
Date Published: 01/22/2015

Notes: All Medical Devices

79 - - - -- General & Plastic Surgery
Date Published: 01/22/2015

Notes: All Medical Devices

80 - - - -- General Hospital/Personal Use
Date Published: 01/22/2015

Notes: All Medical Devices

84 - - - -- Neurological
Date Published: 01/22/2015

Notes: All Medical Devices

85 - - - -- Obstetrical & Gynecological
Date Published: 01/22/2015

Notes: All Medical Devices

86 - - - -- Ophthalmic
Date Published: 01/22/2015

Notes: All Medical Devices

87 - - - -- Orthopedic
Date Published: 01/22/2015

Notes: All Medical Devices

89 - - - -- Physical Medicine
Date Published: 01/22/2015

Notes: All Medical Devices

90 - - - -- Radiological
Date Published: 01/22/2015

Notes: All Medical Devices

Sam Woo Corporation Ltd
Date Published : 09/16/2009
231-6 Kuk Jul-Ri , Jungnam-Myun Kwasung-Gun , Kyounggi-Do, KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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 - - - -- Radiological
Date Published: 08/25/2011

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 - - - -- Radiological
Date Published: 02/01/2019

Notes: All Devices; 3/11/2009

Dongkuk Techco Rubber Industries Sdn. Bhd.
Date Published : 09/16/2009
Plot 31, Jalan 8 Bakar Arang Ind. Estate , 0800 Sungai Petani , Kedah Darul Aman, 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 - - - -- Radiological
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
Blvd. Insurgentes 19030 , Libramiento , 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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
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. (EMCM)
Date Published : 09/16/2009
Middenkampweg 17 , Nijmegen, Gelderland NETHERLANDS
89 M - - LQ Inhibitor, Peridural Fibrosis (Adhesion Barrier)
Date Published: 09/16/2009

Gliatech EMCM Bv
Date Published : 09/16/2009
Gerstweg 2 , Nijmegen, NETHERLANDS
89 M - - LQ Inhibitor, Peridural Fibrosis (Adhesion Barrier)
Date Published: 02/11/2019

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, NETHERLANDS
89 M - - LQ Inhibitor, Peridural Fibrosis (Adhesion Barrier)
Date Published: 02/11/2019

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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
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
P.O. Box 850 , Anwar Khawaja Road Near Wapda Grid Sta. , Sialkot, 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 - - - -- Radiological
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 - - - -- Radiological
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
Maquinarias 2414 , 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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 11/02/2016

Notes: All medical devices


SPAIN


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
Conde De Borrell, 158 , 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 - - - -- Radiological
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

Leventon S. A. U.
Date Published : 10/25/2018
Calle Newton 18 24 , Sant Esteve Sesrovires , Barcelona, SPAIN
80 M - - EB Pump, Infusion, Elastomeric
Date Published: 11/08/2018

Desc: Dosi-Fuser Elastomeric infusion pump

Leventon S.A.U.
Date Published : 11/08/2018
Plaza Europa N 21-23 , L'Hospitalet de Llobregat , Barcelona, SPAIN
80 M - - EB Pump, Infusion, Elastomeric
Date Published: 11/08/2018

Desc: Dosi-Fuser Elastomeric infusion pump

Madespa S.A.
Date Published : 09/16/2009
Rio Jarama, 120 , 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 - - - -- Radiological
Date Published: 09/16/2009

Compex Medical Sa
Date Published : 01/30/2019
ZI Larges Pieces A , Chemin du Devent , Ecublens, 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


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

Taiwan Fuji Latex Co., Ltd.
Date Published : 09/16/2009
46-3 Pi-Dao Li, Tamshui Zhen , 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
79 K - - GO Surgeon's Gloves
Date Published: 09/16/2009

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
5 , 1; Polpichai Soi 1 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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
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, 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 - - - -- Radiological
Date Published: 08/14/2018

Notes: All medical devices

Implants International Ltd.
Date Published : 03/09/2016
Teesside Industrial Est. , 71 Jay Avenue , Stockton-on-Tees, Cleveland 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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
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 - - - -- Radiological
Date Published: 09/16/2009