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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
BIO-BRIDGE SCIENCE, INC.
OAK BROOK,  IL,  US.
Initial Importer;   Repackager/Relabeller;  
BIO-BRIDGE SCIENCE, INC.
OAK BROOK,  IL ,  US.
BIOBRIGHT CORP.
PALM BEACH,  FL,  US.
Initial Importer;  
BIOBRIGHT CORP.
PALM BEACH,  FL ,  US.
BIOCAP S.A.
BUENOS AIRES,  AR.
Manufacturer;  
BIOCAP S.A.
BUENOS AIRES,  AR.
BIOCARDIA, INC.
SOUTH SAN FRANCISCO,  CA,  US.
Manufacturer;   Specification Developer;  
BIOCARDIA, INC.
SOUTH SAN FRANCISCO,  CA ,  US.
BIOCARE ASIA CORPORATION LTD.
SUZHOU, JIANGSU,  CH.
Contract Manufacturer;   Manufacturer;  
BIOCARE ASIA CORPORATION LTD.
SUZHOU, JIANGSU,  CH.
BIOCARE CORP.
HSINCHU,  TW.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BIOCARE CORP.
HSINCHU,  TW.
BIOCARE INTERNATIONAL GROUP
MIAMI,  FL,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
BIOCARE INTERNATIONAL GROUP
MIAMI,  FL ,  US.
BIOCARE MEDICAL, LLC
CONCORD,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOCARE MEDICAL, LLC
CONCORD,  CA ,  US.
BIOCARE SYSTEMS, INC.
PARKER,  CO,  US.
Specification Developer;  
BIOCARE SYSTEMS, INC.
PARKER,  CO ,  US.
BIOCELL LABORATORIES, INC.
RANCHO DOMINGUEZ,  CA,  US.
Manufacturer;  
BIOCELL LABORATORIES, INC.
RANCHO DOMINGUEZ,  CA ,  US.
BIOCERA CO., LTD.
SUNGNAM, GYUNGGI,  KS.
Manufacturer;  
BIOCERA CO., LTD.
SUNGNAM, GYUNGGI,  KS.
BIOCHECK, INC.
FOSTER CITY,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOCHECK, INC.
FOSTER CITY,  CA ,  US.
BIO-CHEM MEDICAL PRODUCTS INC.
HOLLAND,  MI,  US.
Specification Developer;  
BIO-CHEM MEDICAL PRODUCTS INC.
HOLLAND,  MI ,  US.
BIOCHEMICAL DIAGNOSTIC, INC.
BRENTWOOD,  NY,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOCHEMICAL DIAGNOSTIC, INC.
BRENTWOOD,  NY ,  US.
BIOCHEMIE GMBH
KUNDL,  AU.
Contract Manufacturer;  
BIOCHEMIE GMBH
KUNDL,  AU.
BIOCHEMIMMUNOSYSTEMS ITALIA S.P.A.
GUIDONIA MONTECELIO, ROMA,  IT.
Unregistered Foreign Lister;  
BIOCHEMIMMUNOSYSTEMS ITALIA S.P.A.
GUIDONIA MONTECELIO, ROMA,  IT.
BIOCHROM AG
BERLIN,  GM.
Manufacturer;  
BIOCHROM AG
BERLIN,  GM.
BIOCHROM LTD
CAMBRIDGE,  UK.
Manufacturer;  
HARVARD BIOSCIENCES
HOLLISTON,  MA ,  US.
BIO-CLIN, INC.
ST. LOUIS,  MO,  US.
Manufacturer;  
BIO-CLIN, INC.
ST. LOUIS,  MO ,  US.
BIOCOAT, INC.
HORSHAM,  PA,  US.
Manufacturer;  
BIOCOAT, INC.
HORSHAM,  PA ,  US.
BIOCOAT, INC.
SOUTHFIELD,  MI,  US.
Contract Manufacturer;  
BIOCOAT, INC.
SOUTHFIELD,  MI ,  US.
BIOCOMPATIBLES
GALWAY,  EI.
Unregistered Foreign Lister;  
BIOCOMPATIBLES
GALWAY,  EI.
BIOCOMPATIBLES U.K. LIMITED
FARNHAM, SURREY ENGLAND,  UK.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOCOMPATIBLES U.K. LIMITED
FARNHAM, SURREY ENGLAND,  UK.
BIOCOMPOSITES LTD.
KEELE, STAFFORDSHIRE,  UK.
Contract Manufacturer;   Manufacturer;  
BIOCOMPOSITES LTD.
KEELE, STAFFORDSHIRE,  UK.
BIOCOMPOSITES, INC.
WILMINGTON,  NC,  US.
Initial Importer;  
BIOCOMPOSITES, INC.
WILMINGTON,  NC ,  US.
BIO-CONCEPTS, INC.
PHOENIX,  AZ,  US.
Manufacturer;  
BIO-CONCEPTS, INC.
PHOENIX,  AZ ,  US.
BIOCONNECT
SAN DIEGO,  CA,  US.
Manufacturer;  
RF INDUSTRIES, LTD.
SAN DIEGO,  CA ,  US.
BIOCORE MEDICAL TECHNOLOGIES, INC.
SILVER SPRING,  MD,  US.
Manufacturer;  
BIOCORE MEDICAL TECHNOLOGIES, INC.
ELKRIDGE,  MD ,  US.
BIOCOUSTICS INSTRUMENTS, INC.
HANOVER,  MD,  US.
Initial Importer;  
BIOCOUSTICS INSTRUMENTS, INC.
HANOVER,  MD ,  US.
BIOCURE, INC.
NORCROSS,  GA,  US.
Manufacturer;   Specification Developer;  
BIOCURE, INC.
NORCROSS,  GA ,  US.
BIOCURV MEDICAL INSTRUMENTS, INC.
CANTON,  OH,  US.
Contract Manufacturer;   Manufacturer;  
BIOCURV MEDICAL INSTRUMENTS, INC.
CANTON,  OH ,  US.
BIODENT CO., LTD
PAJU, GYEONGGI-DO,  KS.
Manufacturer;  
BIODENT CO., LTD
PAJU, GYEONGGI-DO,  KS.
BIODENT CO., LTD.
ARAKAWA-KU, TOKYO,  JA.
Foreign Exporter;  
BIODENT CO., LTD.
ARAKAWA-KU, TOKYO,  JA.
BIODENT, INC.
ST. BASILE-LE GRAND, QUEBEC,  CA.
Manufacturer;  
BIODENT, INC.
ST. BASILE-LE GRAND, QUEBEC,  CA.
BIO-DERM MEDICAL, INC.
ST. PETERSBURG,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
BIO-DERM MEDICAL, INC.
ST. PETERSBURG,  FL ,  US.
BIODERM SCIENCES, INC.
OXFORD,  MS,  US.
Initial Importer;  
BIODERM SCIENCES, INC.
OXFORD,  MS ,  US.
BIODERM, INC.
LARGO,  FL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIODERM, INC.
LARGO,  FL ,  US.
BIODERMIS CORP.
LAS VEGAS,  NV,  US.
Manufacturer;   Specification Developer;  
BIODERMIS CORP.
LAS VEGAS,  NV ,  US.
BIODESIGN, INC.
SACO,  ME,  US.
Manufacturer;  
MERIDIAN BIOSCIENCE, INC.
CINCINNATI,  OH ,  US.
BIO-DETEK, INC.
PAWTUCKET,  RI,  US.
Manufacturer;  
BIO-DETEK, INC.
PAWTUCKET,  RI ,  US.

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Last Modified: 29 April 2006
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