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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
CARDIO TECHNICS S.A. DE C.V.
SAN ANDRES CHOLULA, PUEBLA,  MX.
Contract Manufacturer;   Manufacturer;  
CARDIO TECHNICS S.A. DE C.V.
SAN ANDRES CHOLULA, PUEBLA,  MX.
CARDIO VASCULAR SALES
ALISO VIEJO,  CA,  US.
Initial Importer;  
WALKER MEDICAL SALES, INC.
ALISO VIEJO,  CA ,  US.
CARDIOBEAT.COM
SCOTTSDALE,  AZ,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
CARDIOBEAT.COM
SCOTTSDALE,  AZ ,  US.
CARDIOBIOMEDICAL CORPORATION
NATICK,  MA,  US.
Specification Developer;  
CARDIOBIOMEDICAL CORPORATION
NATICK,  MA ,  US.
CARDIOCOM LLC
CHANHASSEN,  MN,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
CARDIOCOM LLC
CHANHASSEN,  MN ,  US.
CARDIOCOMM SOLUTIONS, INC.
VICTORIA, B.C.,  CA.
Manufacturer;   Specification Developer;  
CARDIOCOMM SOLUTIONS, INC.
VICTORIA, B.C.,  CA.
CARDIOCOMMAND, INC.
TAMPA,  FL,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
CARDIOCOMMAND, INC.
TAMPA,  FL ,  US.
CARDIODYNAMICS INTERNATIONAL CORP.
SAN DIEGO,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
CARDIODYNAMICS INTERNATIONAL CORP.
SAN DIEGO,  CA ,  US.
CARDIOFOCUS, INC.
MAYNARD,  MA,  US.
Manufacturer;  
CARDIOFOCUS, INC.
MAYNARD,  MA ,  US.
CARDIOGENESIS CORP.
FOOTHILL RANCH,  CA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
CARDIOGENESIS CORP.
FOOT HILL RANCH,  CA ,  US.
CARDIOGRAPHICS, INC.
BOHEMIA,  NY,  US.
Repackager/Relabeller;  
CARDIOGRAPHICS, INC.
BOHEMIA,  NY ,  US.
CARDIOGRIP CORPORATION
BOISE,  ID,  US.
Initial Importer;   Specification Developer;  
CARDIOGRIP CORPORATION
BOISE,  ID ,  US.
CARDIOLINE, INC.
PETALUMA,  CA,  US.
Initial Importer;  
CARDIOLINE, INC.
PETALUMA,  CA ,  US.
CARDIOMAG IMAGING, INC.
SCHENECTADY,  NY,  US.
Manufacturer;  
CARDIOMAG IMAGING, INC.
SCHENECTADY,  NY ,  US.
CARDIOMART
NORTHRIDGE,  CA,  US.
Initial Importer;  
CARDIOMART
NORTHRIDGE,  CA ,  US.
CARDIOMED SUPPLIES, INC.
GORMLEY ONTARIO,  CA.
Manufacturer;  
CARDIOMED SUPPLIES, INC.
GORMLEY, ONTARIO,  CA.
CARDIOMEDICS, INC.
IRVINE,  CA,  US.
Initial Importer;   Manufacturer;  
CARDIOMEDICS, INC.
IRVINE,  CA ,  US.
CARDIOMEDICS, INC.
MIDLAND,  MI,  US.

CARDIOMEDICS, INC.
MIDLAND,  MI ,  US.
CARDIOMEMS, INC.
ATLANTA,  GA,  US.
Specification Developer;  
CARDIOMEMS, INC.
ATLANTA,  GA ,  US.
CARDIOMEND, LLC
SANTA BARBARA,  CA,  US.
Specification Developer;  
CARDIOMEND, LLC
SANTA BARBARA,  CA ,  US.
CARDIONET, INC
SAN DIEGO,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
CARDIONET, INC
SAN DIEGO,  CA ,  US.
CARDIONET, INC
SAN DIEGO,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
CARDIONET, INC
SAN DIEGO,  CA ,  US.
CARDIONETICS, LTD.
FLEET HAMPSHIRE,  UK.
Specification Developer;  
CARDIONETICS, LTD.
FLEET HAMPSHIRE,  UK.
CARDIONICS, INC.
WEBSTER,  TX,  US.
Manufacturer;  
CARDIONICS, INC.
WEBSTER,  TX ,  US.
CARDIOPULMONARY CORP.
MILFORD,  CT,  US.
Manufacturer;  
CARDIOPULMONARY CORP.
MILFORD,  CT ,  US.
CARDIOPULMONARY INSTRUMENTATION
MIAMI,  FL,  US.
Initial Importer;  
CARDIOPULMONARY INSTRUMENTATION
MIAMI,  FL ,  US.
CARDIOPULMONARY TECHNOLOGIES, INC.
SUSSEX,  WI,  US.
Contract Manufacturer;   Manufacturer;  
CARDIOPULMONARY TECHNOLOGIES, INC.
SUSSEX,  WI ,  US.
CARDIOSOFT, L.P.
HOUSTON,  TX,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
CARDIOSOFT, L.P.
HOUSTON,  TX ,  US.
CARDIOSOURCE
BRENTWOOD,  CA,  US.

CARDIOSOURCE
BRENTWOOD,  CA ,  US.
CARDIOSTREAM, LLC
AUSTELL,  GA,  US.
Manufacturer;  
CARDIOSTREAM, LLC
AUSTELL,  GA ,  US.
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
KANSAS CITY,  MO,  US.
Manufacturer;   Repackager/Relabeller;  
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
KANSAS CITY,  MO ,  US.
CARDIOVASCULAR INNOVATIONS
ATHENS,  TX,  US.
Initial Importer;   Specification Developer;  
CARDIOVASCULAR INNOVATIONS
ATHENS,  TX ,  US.
CARDIOVASCULAR INSTRUMENT CORP.
WAKEFIELD,  MA,  US.
Manufacturer;  
CARDIOVASCULAR INSTRUMENT CORP.
WAKEFIELD,  MA ,  US.
CARDIOVASCULAR RESEARCH, INC.
TAMPA,  FL,  US.
Manufacturer;  
CARDIOVASCULAR RESEARCH, INC.
TAMPA,  FL ,  US.
CARDIOVASCULAR SYSTEMS INCORPORATED
SAINT PAUL,  MN,  US.
Manufacturer;   Specification Developer;  
CARDIOVASCULAR SYSTEMS INCORPORATED
SAINT PAUL,  MN ,  US.
CARDIOVASCULAR SYSTEMS, INC.
PLYMOUTH,  MN,  US.
Manufacturer;  
CARDIOVASCULAR SYSTEMS INCORPORATED
SAINT PAUL,  MN ,  US.
CARDIOVENTION, INC.
CUPERTINO,  CA,  US.
Manufacturer;  
CARDIOVENTION, INC.
CUPERTINO,  CA ,  US.
CARDIVA MEDICAL, INC.
MOUNTAIN VIEW,  CA,  US.
Manufacturer;  
CARDIVA MEDICAL, INC.
MOUNTAIN VIEW,  CA ,  US.
CARE & CURE SURGICO
SIALKOT, PUNJAB,  PK.
Manufacturer;  
CARE & CURE SURGICO
SIALKOT, PUNJAB,  PK.
CARE DESK CORP.
MIAMI,  FL,  US.
Initial Importer;  
CARE DESK CORP.
MIAMI,  FL ,  US.

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Last Modified: 29 April 2006
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