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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
CARDICA, INC.
REDWOOD CITY,  CA,  US.
Manufacturer;  
CARDICA, INC.
REDWOOD CITY,  CA ,  US.
CARDIFF ORTHOPEDICS, INC.
CARDIFF,  CA,  US.
Initial Importer;  
CARDIFF ORTHOPEDICS, INC.
CARDIFF,  CA ,  US.
CARDIMA, INC.
FREMONT,  CA,  US.
Manufacturer;  
CARDIMA, INC.
FREMONT,  CA ,  US.
CARDINAL HEALTH
PHILADELPHIA,  PA,  US.
Repackager/Relabeller;  
CARDINAL HEALTH
PHILADELPHIA,  PA ,  US.
CARDINAL HEALTH
WHEELING,  WV,  US.
Initial Importer;  
CARDINAL HEALTH
WHEELING,  WV ,  US.
CARDINAL HEALTH
WOODSTOCK,  IL,  US.
Contract Manufacturer;   Manufacturer;  
CARDINAL HEALTH
WOODSTOCK,  IL ,  US.
CARDINAL HEALTH
WOODSTOCK,  IL,  US.
Repackager/Relabeller;  
CARDINAL HEALTH
WOODSTOCK,  IL ,  US.
CARDINAL HEALTH
HUMACAO,  PR,  US.
Contract Manufacturer;  
CARDINAL HEALTH, INC.
DUBLIN,  OH ,  US.
CARDINAL HEALTH
SANTO DOMINGO,  DR.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
SANTO DOMINGO,  DR.
Manufacturer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
PLUAKDAENG, RAYONG,  TH.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
ANASCO,  PR,  US.
Manufacturer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
ASHEVILLE,  NC,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
CLEVELAND,  OH,  US.
Manufacturer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
EL PASO,  TX,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
FORT MILL,  SC,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
JACKSONVILLE,  TX,  US.
Manufacturer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
MANNFORD,  OK,  US.
Manufacturer;   Specification Developer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
MCGAW PARK,  IL,  US.
Initial Importer;   Repackager/Relabeller;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
MCGAW PARK,  IL,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
MCGAW PARK,  IL,  US.
Specification Developer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
MCGAW PARK,  IL,  US.
Initial Importer;   Specification Developer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
MOBERLY,  MO,  US.
Contract Manufacturer;   Manufacturer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
MONTGOMERY,  NY,  US.
Manufacturer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
ONTARIO,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
ONTARIO,  CA,  US.
Manufacturer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
RIVERSIDE,  CA,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
ST. LOUIS,  MO,  US.
Manufacturer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH
WAUKEGAN,  IL,  US.
Manufacturer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL HEALTH 303, INC.
SAN DIEGO,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
CARDINAL HEALTH 303, INC.
SAN DIEGO,  CA ,  US.
CARDINAL HEALTH 303, INC.
SAN DIEGO,  CA,  US.
Manufacturer;   Specification Developer;  
CARDINAL HEALTH 303, INC.
SAN DIEGO,  CA ,  US.
CARDINAL HEALTH 303,INC.
CREEDMOOR,  NC,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
CARDINAL HEALTH 303, INC.
SAN DIEGO,  CA ,  US.
CARDINAL HEALTH 414 INC.
DUBLIN,  OH,  US.
Specification Developer;  
CARDINAL HEALTH 414 INC.
DUBLIN,  OH ,  US.
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
PENANG,  MY.
Manufacturer;  
CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES
MCGAW PARK,  IL ,  US.
CARDINAL MEDICAL SPECIALTIES, INC.
LOUISVILLE,  KY,  US.
Initial Importer;   Manufacturer;  
CARDINAL MEDICAL SPECIALTIES, INC.
LOUISVILLE,  KY ,  US.
CARDINAL SCALE MFG. CO.
WEBB CITY,  MO,  US.
Manufacturer;  
CARDINAL SCALE MFG. CO.
WEBB CITY,  MO ,  US.
CARDIO CONTROL BV
THE NETHERLANDS,  NL.
Unregistered Foreign Lister;  
CARDIO CONTROL BV
THE NETHERLANDS,  NL.
CARDIO DESIGN PTY. LTD.
LARA VIC.,  AS.
Manufacturer;  
CARDIO DESIGN PTY. LTD.
OAKLEIGH VIC.,  AS.
CARDIO INTERNATIONAL
GRAND ISLAND,  NY,  US.
Initial Importer;  
CARDIO INTERNATIONAL
GROMLEY ONTARIO,  CA.
CARDIO LIFE RESEARCH
LOUVAIN LA NEUVE,  BE.
Foreign Exporter;   Specification Developer;  
CARDIO LIFE RESEARCH
LOUVAIN LA NEUVE,  BE.

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Last Modified: 29 April 2006
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