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US Food and Drug Administration (FDA) - Establishment Registration

FDA Registered Companies - Updated May 2006

What is Establishment Registration?

Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration.
FDA Registrations
FDA Registrations
FDA Registrations
FDA Registrations


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Establishment Owner/Operator
BURNET DISTRIBUTION SA
LE PLESSIS ROBINSON,  FR.
Manufacturer;  
R. M. ALCOCK
PARIS,  FR.
BURNISHINE PRODUCTS
GURNEE,  IL,  US.
Manufacturer;  
WEIMAN PRODUCTS, LLC
GURNEE,  IL ,  US.
BURNSHIELD (PTY) LTD.
WADEVILLE, GERMISTON,  SF.
Manufacturer;  
BURNSHIELD (PTY) LTD.
GERMISTON,  SF.
BURSTENMANN GMBH
STUTZENGRUN,  GM.
Manufacturer;  
BURSTENMANN GMBH
STUTZENGRUN,  GM.
BURTON INDUSTRIES, INC.
MENTOR,  OH,  US.
Contract Manufacturer;  
BURTON INDUSTRIES, INC.
MENTOR,  OH ,  US.
BURTON MEDICAL PRODUCTS CORP.
CHATSWORTH,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
LUXO A.S.
OSLO,  NO.
BUSCH & CO. KG
ENGELSKIRCHEN,  GM.
Manufacturer;  
BUSCH & CO. KG
ENGELSKIRCHEN,  GM.
BUSHNELL, INC.
OVERLAND PARK,  KS,  US.
Initial Importer;  
BUSHNELL PERFORMANCE OPTICS
OVERLAND PARK,  KS ,  US.
BUSINESS & BUSINESS (HK) CO.
SHEUNG WAN,  HK.
Unregistered Foreign Lister;  
BUSINESS & BUSINESS (HK) CO.
SHEUNG WAN,  HK.
BUSINESS POINT, INC.
IRVINE,  CA,  US.
Initial Importer;  
BUSINESS POINT, INC.
IRVINE,  CA ,  US.
BUSINESS SPECIALTIES IMPORTS
NEWPORT BEACH,  CA,  US.
Initial Importer;  
BUSINESS SPECIALTIES IMPORTS
NEWPORT BEACH,  CA ,  US.
BUSNA COMPONENTI PER OCCHIALI DI DELL'OSBELLUIGIA
AGORDO (BL),  IT.
Manufacturer;  
BUSNA COMPONENTI PER OCCHIALI DI DELL'OSBELLUIGIA
AGORDO (BL),  IT.
BUSSE HOSPITAL DISPOSABLES, INC.
HAUPPAUGE,  NY,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
ROBERT BUSSE & CO., INC.
HAUPPAUGE,  NY ,  US.
BUTACAS GUADALAJARA
ZAPOPAN, JALISCO,  MX.
Manufacturer;  
BUTACAS GUADALAJARA
ZAPOPAN, JALISCO,  MX.
BUTH-NA-BODHAIGE, INC.
WAKE FOREST,  NC,  US.
Initial Importer;  
THE BODY SHOP INTERNATIONAL PLC
WEST SUSSEX,  UK.
BUTI SONS INTL.
SIALKOT,  PK.
Unregistered Foreign Lister;  
BUTI SONS INTL.
SIALKOT,  PK.
BUTTERFLY ORIGINALS LTD.
CHERRY HILL,  NJ,  US.
Initial Importer;  
BUTTERFLY ORIGINALS LTD.
CHERRY HILL,  NJ ,  US.
BUTTNER-FRANK GMBH
ERLANGEN,  GM.
Foreign Exporter;   Manufacturer;  
BUTTNER-FRANK GMBH
ERLANGEN,  GM.
BUXTON BIOMEDICAL, INC.
EAST HANOVER,  NJ,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
BUXTON BIOMEDICAL, INC.
EAST HANOVER,  NJ ,  US.
BUXTON MEDICAL EQUIPMENT CORP.
LINDENHURST,  NY,  US.
Manufacturer;  
BUXTON MEDICAL EQUIPMENT CORP.
LINDENHURST,  NY ,  US.
BUY DIRECT PROMOTIONS, INC.
VANCOUVER,B.C.,  CA.
Unregistered Foreign Lister;  
BUY DIRECT PROMOTIONS, INC.
VANCOUVER,B.C.,  CA.
BUY PREGNANCY TESTS
BOONEVILLE,  AR,  US.
Initial Importer;  
BUY PREGNANCY TESTS
BOONEVILLE,  AR ,  US.
BUYMD, INC.
ATLANTA,  GA,  US.
Initial Importer;  
BUYMD, INC.
ATLANTA,  GA ,  US.
BUY-RITE COSTUME JEWELRY, INC.
FREEHOLD,  NJ,  US.
Initial Importer;  
BUY-RITE COSTUME JEWELRY, INC.
FREEHOLD,  NJ ,  US.
BUZTRONICS INC.
INDIANAPOLIS,  IN,  US.
Initial Importer;  
BUZTRONICS INC.
INDIANAPOLIS,  IN ,  US.
BUZZINI EXPORT
CASTELMARTER, COMO,  IT.
Unregistered Foreign Lister;  
BUZZINI EXPORT
CASTELMARTER, COMO,  IT.
BVR TECHNOLOGIES COMPANY
ROCKFORD,  IL,  US.
Manufacturer;  
BVR TECHNOLOGIES COMPANY
ROCKFORD,  IL ,  US.
BW MANUFACTURING CO., INC.
BRISTOL,  CT,  US.
Contract Manufacturer;   Manufacturer;  
BW MANUFACTURING CO., INC.
BRISTOL,  CT ,  US.
BWELL INC.
ALCOA,  TN,  US.
Manufacturer;  
BWELL INC.
ALCOA,  TN ,  US.
BXD ENTERPRISES
HOLIDAY,  FL,  US.
Initial Importer;  
BXD ENTERPRISES
HOLIDAY,  FL ,  US.
BXL INTERNATIONAL SALES INC.
CALGARY,ALBERTA,  CA.
Foreign Exporter;  
BXL INTERNATIONAL SALES INC.
CALGARY,ALBERTA,  CA.
BY JEMANY DESIGNS
THORNTON,  CO,  US.
Initial Importer;  
BY JEMANY DESIGNS
THORNTON,  CO ,  US.
BYCAST INC.
VANCOUVER,  CA.
Manufacturer;  
BYCAST INC.
VANCOUVER,  CA.
BYERLEY'S MEDICAL EQUIPMENT, INC.
CHATTANOOGA,  TN,  US.
Initial Importer;  
BYERLEY'S MEDICAL EQUIPMENT, INC.
CHATTANOOGA,  TN ,  US.
BYERS PEAK, INC.
WHEATRIDGE,  CO,  US.
Contract Manufacturer;  
BYERS PEAK, INC.
WHEATRIDGE,  CO ,  US.
BYGAYLE
RIDGELAND,  WI,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BYGAYLE
RIDGELAND,  WI ,  US.
BY-PASS MAKAFIM LTD.
HERZELIA,  IS.
Manufacturer;  
BY-PASS MAKAFIM LTD.
HERZELIA,  IS.
BYPRO TECHNOLOGY, INC.
BANGOR,  ME,  US.
Initial Importer;  
BYPRO TECHNOLOGIES, BRIAN BAZOWSKY
UPPER SALMON CREEK,  CA.
BYRNE MEDICAL INC.
CONROE,  TX,  US.
Manufacturer;  
BYRNE MEDICAL INC.
CONROE,  TX ,  US.
BYRON E. WHITE ENTERPRISES
NASHVILLE,  TN,  US.
Initial Importer;  
BYRON E. WHITE ENTERPRISES
NASHVILLE,  TN ,  US.

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Last Modified: 29 April 2006
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