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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
BIODEX MEDICAL SYSTEMS, INC.
SHIRLEY,  NY,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIODEX MEDICAL SYSTEMS, INC.
SHIRLEY,  NY ,  US.
BIO-DIAGNOSTICS LTD.
WORCESTERSHIRE,  UK.
Manufacturer;  
BIO-DIAGNOSTICS LTD.
WORCESTERSHIRE,  UK.
BIODYNAMICS CORP.
SEATTLE,  WA,  US.
Manufacturer;   Specification Developer;  
BIODYNAMICS CORP.
SEATTLE,  WA ,  US.
BIOELECTRONICS CORP.
MURRIETA,  CA,  US.
Specification Developer;  
BIOELECTRONICS CORP.
MURRIETA,  CA ,  US.
BIOENGINEERING LABORATORIES SPA
CANTU (CO),  IT.
Manufacturer;  
BIOENGINEERING LABORATORIES SPA
CANTU (CO),  IT.
BIOENVELOP AGRO, INC.
ST-HYACINTHE, QUEBEC,  CA.
Manufacturer;  
BIOENVELOP AGRO, INC.
ST-HYACINTHE, QUEBEC,  CA.
BIOFARM S.R.L.
MILANO,  IT.
Unregistered Foreign Lister;  
BIOFARM S.R.L.
MILANO,  IT.
BIO-FEEDBACK SYSTEMS, INC.
BOULDER,  CO,  US.
Manufacturer;  
BIO-FEEDBACK SYSTEMS, INC.
BOULDER,  CO ,  US.
BIOFILM, INC.
VISTA,  CA,  US.
Manufacturer;  
BIOFILM, INC.
VISTA,  CA ,  US.
BIO-FLEX INTERNATIONAL,INC.
HALLANDALE BEACH,  FL,  US.
Initial Importer;  
BIO-FLEX INTERNATIONAL,INC.
HALLANDALE BEACH,  FL ,  US.
BIOFLEX MEDICAL MAGNETICS, INC.
OAKLAND PARK,  FL,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
BIOFLEX MEDICAL MAGNETICS, INC.
OAKLAND PARK,  FL ,  US.
BIOFLEX, INC.
COLUMBUS,  OH,  US.
Manufacturer;  
BIOFLEX, INC.
COLUMBUS,  OH ,  US.
BIOFONS, LTD.
TURKU,  FI.
Manufacturer;  
BIOFONS, LTD.
TURKU,  FI.
BIOFOODS, INC.
OSKALOOSA,  KS,  US.
Contract Manufacturer;  
BIOCORE MEDICAL TECHNOLOGIES, INC.
ELKRIDGE,  MD ,  US.
BIOFORM MEDICAL, INC.
FRANKSVILLE,  WI,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Contract Sterilizer;  
BIOFORM MEDICAL, INC.
FRANKSVILLE,  WI ,  US.
BIOFORM MEDICAL, INC.
SAN MATEO,  CA,  US.
Specification Developer;  
BIOFORM MEDICAL, INC.
FRANKSVILLE,  WI ,  US.
BIO-GATE USA, INC.
BUENA PARK,  CA,  US.
Initial Importer;   Manufacturer;  
BIO-GATE USA, INC.
BUENA PARK,  CA ,  US.
BIOGENEX LABORATORIES, INC.
SAN RAMON,  CA,  US.
Manufacturer;  
BIOGENEX LABORATORIES, INC.
SAN RAMON,  CA ,  US.
BIOGENIC DENTAL CORP.
UTICA,  NY,  US.
Initial Importer;   Contract Manufacturer;  
BIOGENIC DENTAL CORP.
UTICA,  NY ,  US.
BIOGENICS
NAPA,  CA,  US.
Initial Importer;  
BIOGENICS
NAPA,  CA ,  US.
BIOGRIP, INC.
FAIR OAKS,  CA,  US.
Manufacturer;  
BIOGRIP, INC.
FAIR OAKS,  CA ,  US.
BIOHIT OYJ
HELSINKI,  FI.
Manufacturer;  
BIOHIT OYJ
HELSINKI,  FI.
BIOHORIZONS IMPLANT SYSTEMS, INC.
BIRMINGHAM,  AL,  US.
Manufacturer;  
BIOHORIZONS IMPLANT SYSTEMS, INC.
BIRMINGHAM,  AL ,  US.
BIO-HOSPITAL AB
KOPPARBERG,  SW.
Contract Manufacturer;   Manufacturer;  
BIO-HOSPITAL AB
KOPPARBERG,  SW.
BIO-IMPLANT SYSTEMS, INC.
NEWPORT BEACH,  CA,  US.
Specification Developer;  
BIO-IMPLANT SYSTEMS, INC.
NEWPORT BEACH,  CA ,  US.
BIOINFERA, INC.
BEACHWOOD,  OH,  US.
Initial Importer;   Manufacturer;  
BIOINFERA, INC.
BEACHWOOD,  OH ,  US.
BIOJECT, INC.
TUALATIN,  OR,  US.
Manufacturer;  
BIOJECT MEDICAL TECHNOLOGIES INC.
BEDMINSTER,  NJ ,  US.
BIOKINETIX CORP.
STAMFORD,  CT,  US.
Manufacturer;  
BIOKINETIX CORP.
STAMFORD,  CT ,  US.
BIOKIT S.A.
BARCELONA,  SP.
Foreign Exporter;   Manufacturer;   Repackager/Relabeller;  
BIOKIT S.A.
BARCELONA,  SP.
BIOKIT USA, INC.
LEXINGTON,  MA,  US.
Initial Importer;  
BIOKIT S.A.
BARCELONA,  SP.
BIO-KLEEN SURGIGLOVE SDN. BHD.
NILAI, N. SEMBILAN,  MY.
Manufacturer;  
BIO-KLEEN SURGIGLOVE SDN. BHD.
NILAI, N. SEMBILAN,  MY.
BIOKOSMES SRL
BOSISIO PARINI,LECCO,  IT.
Contract Manufacturer;  
BIOKOSMES SRL
BOSISIO PARINI,LECCO,  IT.
BIOLAB CO.
BAYAMON,  PR,  US.
Manufacturer;  
BIOLAB CO.
BAYAMON,  PR ,  US.
BIOLAB EQUIPMENT CANADA LTD.
OAKVILLE, ONTARIO,  CA.
Manufacturer;  
BIOLAB EQUIPMENT CANADA LTD.
OAKVILLE, ONTARIO,  CA.
BIOLAND TECHNOLOGY LTD.
NORTH POINT,  HK.
Manufacturer;  
BIOLAND TECHNOLOGY LTD.
NORTH POINT,  HK.
BIOLARGO USA, INC.
LAGUNA HILLS,  CA,  US.
Specification Developer;  
BIOLARGO USA, INC.
LAGUNA HILLS,  CA ,  US.
BIOLASE EUROPE GMBH
FLOSS,  GM.
Manufacturer;  
BIOLASE TECHNOLOGY, INC.
IRVINE,  CA ,  US.
BIOLASE TECHNOLOGY, INC.
IRVINE,  CA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BIOLASE TECHNOLOGY, INC.
IRVINE,  CA ,  US.
BIOLIFE SOLUTIONS, INC.
OWEGO,  NY,  US.
Manufacturer;  
BIOLIFE SOLUTIONS, INC.
OWEGO,  NY ,  US.
BIOLIFE, LLC
SARASOTA,  FL,  US.
Manufacturer;  
BIOLIFE, LLC
SARASOTA,  FL ,  US.

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Last Modified: 29 April 2006
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