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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
BO ENTERPRISES
WOODLAND HILLS,  CA,  US.
Specification Developer;  
BO ENTERPRISES
WOODLAND HILLS,  CA ,  US.
BO SHOWN SPECTACLE INDUSTRIAL CO., LTD.
TAINAN,  TW.
Manufacturer;  
BO SHOWN SPECTACLE INDUSTRIAL CO., LTD.
TAINAN,  TW.
BO SUNG OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
BO SUNG OPTICAL CO.
DAEGU,  KS.
BOARDMAN INTERNATIONAL, LTD.
SHANGHAI,  CH.
Manufacturer;   Specification Developer;  
BOARDMAN INTERNATIONAL, LTD.
SHANGHAI,  CH.
BOAZUL MEDICAL AB
LIDKOPING,  SW.
Unregistered Foreign Lister;  
BOAZUL MEDICAL AB
LIDKOPING,  SW.
BOB BARKER CO., INC.
FUQUAY-VARINA,  NC,  US.
Initial Importer;  
BOB BARKER CO., INC.
FUQUAY-VARINA,  NC ,  US.
BOB INSTRUMENTS GMBH
TUTTLINGEN,  GM.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
MEDICON, E.G.
TUTTLINGEN,  GM.
BOB J. JOHNSON & ASSOCIATES
HOUSTON,  TX,  US.
Manufacturer;  
BOB J. JOHNSON & ASSOCIATES
HOUSTON,  TX ,  US.
BOB, INC.
NEW HOPE,  MN,  US.
Contract Manufacturer;  
BOB, INC.
NEW HOPE,  MN ,  US.
BOBES S.A.
MADRID,  SP.
Manufacturer;  
BOBES S.A.
MADRID,  SP.
BOB'S STORES
MERIDEN,  CT,  US.
Initial Importer;  
BOB'S STORES
MERIDEN,  CT ,  US.
BOCA MEDICAL PRODUCTS, INC.
COCONUT CREEK,  FL,  US.
Initial Importer;  
BOCA MEDICAL PRODUCTS, INC.
COCONUT CREEK,  FL ,  US.
BOCA PHARMACAL, INC.
COCONUT CREEK,  FL,  US.
Initial Importer;  
BOCA PHARMACAL, INC.
COCONUT CREEK,  FL ,  US.
BOCA SCIENTIFIC INC.
BOCA RATON,  FL,  US.
Initial Importer;  
BOCA SCIENTIFIC INC.
BOCA RATON,  FL ,  US.
BOCHICA
LOS CHAGUARAMOS,CARACAS,  VE.
Manufacturer;  
BOCHICA
LOS CHAGUARAMOS,CARACAS,  VE.
BODAN LTD.
LABUAN F.T.,  MY.
Contract Manufacturer;  
BODAN LTD.
HONG KONG,  HK.
BODEN REISSZEUGE BAVARIA GMBH
WILHELMSDORF,  GM.
Manufacturer;  
BODEN REISSZEUGE BAVARIA GMBH
WILHELMSDORF,  GM.
BODITECH L.L.C.
MONMOUTH JCT.,  NJ,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
BODITECH L.L.C.
MONMOUTH JCT.,  NJ ,  US.
BODY ALIGN, LLC
HICKSVILLE,  NY,  US.
Initial Importer;  
BODY ALIGN, LLC
HICKSVILLE,  NY ,  US.
BODY AND SOLE PATCHES, LLC.
PROVO,  UT,  US.
Initial Importer;   Repackager/Relabeller;  
BODY AND SOLE PATCHES, LLC.
PROVO,  UT ,  US.
BODY BAT, INC.
ST. PETERSBURG BEACH,  FL,  US.
Repackager/Relabeller;  
BODY BAT, INC.
ST. PETERSBURG BEACH,  FL ,  US.
BODY CLOCK HEALTH CARE LTD
LONDON, ENGLAND,  UK.
Repackager/Relabeller;  
BODY CLOCK HEALTH CARE LTD
LONDON, ENGLAND,  UK.
BODY FIELDS USA, INC.
DES PLAINES,  IL,  US.
Initial Importer;  
BODY FIELDS USA, INC.
DES PLAINES,  IL ,  US.
BODY SPECS
GRASS VALLEY,  CA,  US.
Initial Importer;  
BODY SPECS
GRASS VALLEY,  CA ,  US.
BODY TECH 1 NW
MUKILTEO,  WA,  US.
Manufacturer;  
BODY TECH 1 NW
MUKILTEO,  WA ,  US.
BODY WATCH, INC.
WINSTON-SALEM,  NC,  US.
Repackager/Relabeller;  
BODY WATCH, INC.
WINSTON-SALEM,  NC ,  US.
BODY WELL DESIGN,LLC
SPOKANE,  WA,  US.
Manufacturer;  
BODY WELL DESIGN,LLC
SPOKANE,  WA ,  US.
BODYCON CO., LTD
INCHEON,  KS.
Manufacturer;  
BODYCON CO., LTD
SUWON-SI, GYEONGGI-DO,  KS.
BODYCON CO., LTD
SUWON-SI, GYEONGGI-DO,  KS.
Manufacturer;  
BODYCON CO., LTD
SUWON-SI, GYEONGGI-DO,  KS.
BODYLINE COMFORT SYSTEMS
JACKSONVILLE,  FL,  US.
Initial Importer;  
BODYLINE COMFORT SYSTEMS
JACKSONVILLE,  FL ,  US.
BODYMEDIA, INC.
PITTSBURGH,  PA,  US.
Specification Developer;  
BODYMEDIA, INC.
PITTSBURGH,  PA ,  US.
BODYPOINT DESIGNS, INC.
SEATTLE,  WA,  US.
Initial Importer;   Manufacturer;  
BODYPOINT DESIGNS, INC.
SEATTLE,  WA ,  US.
BODYWISE (UK), LTD.
BRISTOL, AVON,  UK.
Manufacturer;  
BODYWISE (UK), LTD.
BRISTOL,  UK.
BOECKELER INSTRUMENTS, INC.
TUCSON,  AZ,  US.
Manufacturer;  
BOECKELER INSTRUMENTS, INC.
TUCSON,  AZ ,  US.
BOEDEKER PLASTICS, INC.
SHINER,  TX,  US.
Contract Manufacturer;  
BOEDEKER PLASTICS, INC.
SHINER,  TX ,  US.
BOEHM SURGICAL INSTRUMENT CORP.
ROCHESTER,  NY,  US.
Manufacturer;  
BOEHM SURGICAL INSTRUMENT CORP.
ROCHESTER,  NY ,  US.
BOEHRINGER BIOCHEMIA ROBIN S.P.A.
MONZA,  IT.
Manufacturer;  
BOEHRINGER BIOCHEMIA ROBIN S.P.A.
MILANO,  IT.
BOEHRINGER INGELHEIM ROXANE INC.
COLUMBUS,  OH,  US.
Manufacturer;  
BOEHRINGER INGELHEIM CORPORATION
RIDGEFIELD,  CT ,  US.
BOEHRINGER LABORATORIES
NORRISTOWN,  PA,  US.
Manufacturer;  
BOEHRINGER LABORATORIES
NORRISTOWN,  PA ,  US.
BOHUS BIOTECH AB
STROMSTAD,  SW.
Manufacturer;  
BOHUS BIOTECH AB
STROMSTAD,  SW.

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Last Modified: 29 April 2006
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