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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
BECKMAN COULTER INC. (SAGIAN OPERATION)
INDIANAPOLIS,  IN,  US.
Manufacturer;   Specification Developer;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
BREA,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
CARLSBAD,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
CHASKA,  MN,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
FLORENCE,  KY,  US.
Manufacturer;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
FULLERTON,  CA,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
HIALEAH,  FL,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
HIALEAH,  FL,  US.
Manufacturer;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
HIALEAH,  FL,  US.
Manufacturer;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
MIAMI,  FL,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
PALO ALTO,  CA,  US.
Manufacturer;   Specification Developer;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
PORTERVILLE,  CA,  US.
Manufacturer;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC.
SAN DIEGO,  CA,  US.
Specification Developer;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC. (IMMUNOTECH, S.A.)
MARSEILLE, CEDEX 9,  FR.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC. (IRELAND)
GALWAY,  EI.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC. PRIMARY CARE DIAGNOSTICS
PALO ALTO,  CA,  US.
Specification Developer;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECKMAN COULTER, INC. PRIMARY CARE DIAGNOSTICS
SHARON HILL,  PA,  US.
Manufacturer;   Specification Developer;  
BECKMAN COULTER, INC.
FULLERTON,  CA ,  US.
BECTON DICKINSON
FRANKLIN LAKES,  NJ,  US.
Initial Importer;   Specification Developer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON AND CO.
DUBLIN,  EI.
Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON AND CO.
MADISON,  WI,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON CARIBE LTD.
CAYEY,  PR,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON CARIBE LTD.
COMERIO,  PR,  US.
Contract Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON CARIBE LTD.
JUNCOS,  PR,  US.
Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
SINGAPORE,  SN.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON DE MEXICO
CUAUTITLAN, IZCALLI,  MX.
Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON FRANCE, SA
LE PONT DE CLAIX,  FR.
Unregistered Foreign Lister;  
BECTON DICKINSON FRANCE, SA
LE PONT DE CLAIX,  FR.
BECTON DICKINSON GMBH
HEIDELBERG,  GM.
Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON IND. CIRURGICAS LTDA.
CURITIBA, PARANA,  BR.
Manufacturer;   Remanufacturer;   Contract Sterilizer;   Repackager/Relabeller;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
JUIZ DE FORA/MINAS GERAIS,  BR.
Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON INFUSION THERAPY AB
HELSINGBORG,  SW.
Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
SANDY,  UT,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON MEDICAL (SINGAPORE)
SINGAPORE,  SN.
Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON MEDICAL SYSTEMS
CANAAN,  CT,  US.
Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON MEDICAL SYSTEMS
FRANKLIN,  WI,  US.
Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON MEDICAL SYSTEMS
HANCOCK,  NY,  US.
Contract Sterilizer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON OPHTHALMIC SYSTEMS
BIDFORD-ON-AVON, WARWICKSHIRE,  UK.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON PHARMACEUTICAL SYSTEMS
LE PONT DE CLAIX,  FR.
Unregistered Foreign Lister;  
BECTON DICKINSON PHARMACEUTICAL SYSTEMS
LE PONT DE CLAIX,  FR.
BECTON DICKINSON VASCULAR ACCESS S.A. DE CV
NOGALES, SONORA, C.P.,  MX.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON, S.A.
FRAGA, HUESCA,  SP.
Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
BECTON DICKINSON, S.A.
MADRID,  SP.
Manufacturer;   Contract Sterilizer;   Repackager/Relabeller;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.

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Last Modified: 29 April 2006
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