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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
COASTAL RESOURCES, INC.
JACKSONVILLE,  FL,  US.
Initial Importer;  
COASTAL RESOURCES, INC.
JACKSONVILLE,  FL ,  US.
COASTLINE DE MEXICO S.A. DE C.V.
TIJUANA, B.C.,  MX.
Contract Manufacturer;  
COASTLINE INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
COATS AMERICAN, INC.
HENDERSONVILLE,  NC,  US.
Contract Manufacturer;   Manufacturer;  
COATS AMERICAN, INC.
CHARLOTTE,  NC ,  US.
COAXIA, INC.
MAPLE GROVE,  MN,  US.
Manufacturer;  
COAXIA, INC.
MAPLE GROVE,  MN ,  US.
COB TECHNOLOGY ASIA SDN BHD
SG. PETANI, KEDAH,  MY.
Contract Manufacturer;  
COB TECHNOLOGY ASIA SDN BHD
SG. PETANI, KEDAH,  MY.
COBE CARDIOVASCULAR, INC.
ARVADA,  CO,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
COBE CARDIOVASCULAR, INC.
ARVADA,  CO ,  US.
COBE CHEMICAL CO.
PICO RIVERA,  CA,  US.
Manufacturer;  
COBE CHEMICAL CO.
PICO RIVERA,  CA ,  US.
COBE STERILIZATION SERVICES, INC.
LAKEWOOD,  CO,  US.
Contract Sterilizer;  
GAMBRO BCT, INC.
LAKEWOOD,  CO ,  US.
COBRA VISION
CUMMING,  GA,  US.
Initial Importer;  
COBRA VISION
CUMMING,  GA ,  US.
COCHLEAR AMERICAS
ENGLEWOOD,  CO,  US.
Initial Importer;  
COCHLEAR LTD.
LANE COVE, NSW,  AS.
COCHLEAR AMERICAS
ENGLEWOOD,  CO,  US.
Initial Importer;  
COCHLEAR LTD.
LANE COVE NSW,  AS.
COCHLEAR LTD.
LANE COVE NSW,  AS.
Manufacturer;  
COCHLEAR LTD.
LANE COVE NSW,  AS.
COCHRAN MEDICAL
BEDFORD,  MA,  US.
Manufacturer;  
COCHRAN MEDICAL
BEDFORD,  MA ,  US.
COCNCAVE OPTIC GMBH
BAD WILDBAD,  GM.
Unregistered Foreign Lister;  
COCNCAVE OPTIC GMBH
BAD WILDBAD,  GM.
COCOHERB, INC.
HAMPUYONG GUN, JEONNAM,  KS.
Manufacturer;  
COCOHERB, INC.
HAMPUYONG GUN, JEONNAM,  KS.
COCOSA C.O. CONFECCIONES ORTOPEDICAS, S.A.
SAN JOSE,  CS.
Manufacturer;  
LEEDER GROUP, INC.
MIAMI,  FL ,  US.
CODA EYEWEAR, INC.
ST. PAUL,  MN,  US.
Initial Importer;   Specification Developer;  
CODA EYEWEAR, INC.
ST. PAUL,  MN ,  US.
CODAN MEDICAL APS.
ROEDBY,  DA.
Manufacturer;  
CODAN HOLDING APS.
HOERSHOLM,  DA.
CODAN MEDIZINISCHE GERATE GMBH & CO. KG
LENSAHN,  GM.
Manufacturer;  
CODAN HOLDING GMBH & CO. KG
LENSAHN,  GM.
CODAN PORTUGAL-INSTRUMENTOS MEDICOS, LDA
ODIVELAS CODEX,  PO.
Manufacturer;  
CODAN HOLDING GMBH & CO. KG
LENSAHN,  GM.
CODAN STERITEX APS
ESPERGAERDE,  DA.
Manufacturer;   Contract Sterilizer;  
CODAN HOLDING APS.
HOERSHOLM,  DA.
CODAN US CORP.
SANTA ANA,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
CODAN HOLDING GMBH & CO. KG
LENSAHN,  GM.
CODENT TECHNICAL INDUSTRY CO., LTD.
HSIN CHUANG CITY, TAIPEI,  TW.
Manufacturer;  
CODENT TECHNICAL INDUSTRY CO., LTD.
HSIN CHUANG CITY, TAIPEI,  TW.
CODI INTERNATIONAL BV
TURBINESTRAAT 13-19,  NL.
Manufacturer;  
CODI INTERNATIONAL BV
TURBINESTRAAT 13-19,  NL.
CODIR S.A.
BAZAINVILLE, LLE DE FRANCE,  FR.
Foreign Exporter;  
GUILDINVEST S.A.
NANTERRE, LLE DE FRANCE,  FR.
CODISOFT, INC.
PALDAL-GU,KYEONGGI-DO,SUWON-SI,  KS.
Manufacturer;  
CODISOFT, INC.
PALDAL-GU,KYEONGGI-DO,SUWON-SI,  KS.
CODISOFT, INC.
SUWON-SI, GYEONGGI-DO,  KS.
Manufacturer;  
CODISOFT, INC.
SUWON-SI, GYEONGGI-DO,  KS.
CODMAN & SHURTLEFF, INC.
NEW BEDFORD,  MA,  US.
Manufacturer;  
CODMAN & SHURTLEFF, INC.
RAYNHAM,  MA ,  US.
CODMAN & SHURTLEFF, INC.
RAYNHAM,  MA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
CODMAN & SHURTLEFF, INC.
RAYNHAM,  MA ,  US.
CODMAN AND SHURTLEFF, INC.
BRIDGEWATER,  MA,  US.
Repackager/Relabeller;  
CODMAN & SHURTLEFF, INC.
RAYNHAM,  MA ,  US.
CODMAN, S'ARL
LE LOCLE,  SZ.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
CODMAN & SHURTLEFF, INC.
RAYNHAM,  MA ,  US.
CODONICS, INC.
MIDDLEBURG HEIGHTS,  OH,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
CODONICS, INC.
MIDDLEBURG HEIGHTS,  OH ,  US.
COEUR MEDICAL
WASHINGTON,  NC,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
COEUR, INC.
LEBANON,  TN ,  US.
COEUR, INC.
SHEBOYGAN,  WI,  US.
Contract Manufacturer;  
COEUR, INC.
LEBANON,  TN ,  US.
COEYE, INC.
WEST MELBOURNE,  FL,  US.
Initial Importer;   Remanufacturer;  
COEYE, INC.
WEST MELBOURNE,  FL ,  US.
COGENT TECHNOLOGY LIMITED
WOODBRIDGE, SUFFOLK,  UK.
Contract Manufacturer;  
COGENT TECHNOLOGY LIMITED
WOODBRIDGE, SUFFOLK,  UK.
COHEN FASHION BOCA
BOCA RATON,  FL,  US.
Initial Importer;  
COHEN FASHION BOCA
BOCA RATON,  FL ,  US.
COHERENT SYSTEMS, INC.
BAYTOWN,  TX,  US.
Contract Manufacturer;   Manufacturer;  
COHERENT SYSTEMS, INC.
BAYTOWN,  TX ,  US.
COHR, INC.
ARLINGTON,  WA,  US.
Manufacturer;  
COHR, INC.
ARLINGTON,  WA ,  US.
COIN STUDIO, LLC
BROOKLYN,  NY,  US.
Initial Importer;  
COIN STUDIO, LLC
BROOKLYN,  NY ,  US.

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Last Modified: 29 April 2006
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