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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
COOLIBAR LLC
ST. LOUIS PARK,  MN,  US.
Initial Importer;  
COOLIBAR LLC
ST. LOUIS PARK,  MN ,  US.
COOLSKIN CORP.
WESTLAKE VILLAGE,  CA,  US.
Specification Developer;  
COOLSKIN CORP.
WESTLAKE VILLAGE,  CA ,  US.
COOLSYSTEMS, INC.
BERKELEY,  CA,  US.
Manufacturer;   Specification Developer;  
COOLSYSTEMS, INC.
BERKELEY,  CA ,  US.
COOPERATIVE WORKSHOPS, INC.
SEDALIA,  MO,  US.
Repackager/Relabeller;  
CWI
SEDALIA,  MO ,  US.
COOPERSURGICAL, INC.
NEWBURY,  OH,  US.
Manufacturer;   Specification Developer;  
COOPERSURGICAL, INC.
TRUMBULL,  CT ,  US.
COOPERSURGICAL, INC.
TRUMBULL,  CT,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
COOPERSURGICAL, INC.
TRUMBULL,  CT ,  US.
COOPERVISION MANUFACTURING, LTD.
CHANDLERS FORD,  UK.
Manufacturer;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION MANUFACTURING, LTD.
FAREHAM,  UK.
Contract Manufacturer;   Manufacturer;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION MANUFACTURING, LTD.
HAMBLE,  UK.
Contract Manufacturer;   Manufacturer;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION MANUFACTURING, LTD.
HANTS, HAMPSHIRE,  UK.
Manufacturer;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION MANUFACTURING, LTD.
ROMSEY, HAMPSHIRE,  UK.
Repackager/Relabeller;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION MANUFACTURING, LTD.
SOUTHAMPTON,  UK.
Contract Manufacturer;   Manufacturer;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION MANUFACTURING, LTD.
SOUTHAMPTON, HAMPSHIRE,  UK.
Specification Developer;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION SURGICAL, INC.
LAKE FOREST,  CA,  US.
Initial Importer;  
COOPERVISION SURGICAL
NEDLANDS, PERTH,  AS.
COOPERVISION, INC.
ALBUQUERQUE,  NM,  US.
Manufacturer;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION, INC.
NORFOLK,  VA,  US.
Contract Manufacturer;   Manufacturer;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION, INC.
ROCHESTER,  NY,  US.
Initial Importer;   Repackager/Relabeller;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION, INC.
SCOTTSVILLE,  NY,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPERVISION, INC.
SOUTH SAN FRANCISCO,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
THE COOPER COMPANIES
PLEASANTON,  CA ,  US.
COOPER-WEATHERFORD, LLC
GERMANTOWN,  TN,  US.
Specification Developer;   Repackager/Relabeller;  
COOPER-WEATHERFORD, LLC
GERMANTOWN,  TN ,  US.
CO-OPTICS OF AMERICA LABORATORY, INC.
ONEONTA,  NY,  US.
Initial Importer;  
CO-OPTICS OF AMERICA LABORATORY, INC.
ONEONTA,  NY ,  US.
CO-ORAL-ITE DENTAL MFG. CO.
DIAMOND SPRINGS,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
CO-ORAL-ITE DENTAL MFG. CO.
DIAMOND SPRINGS,  CA ,  US.
COORDINATED STRATEGIC ALLIANCES
CHESTER,  NY,  US.
Initial Importer;  
COORDINATED STRATEGIC ALLIANCES
CHESTER,  NY ,  US.
COPAN CORP.
LARGO,  FL,  US.
Contract Manufacturer;  
COPAN CORP.
LARGO,  FL ,  US.
COPAN DIAGNOSTICS, INC.
CORONA,  CA,  US.
Initial Importer;   Remanufacturer;   Repackager/Relabeller;  
COPAN ITALIA
BRESCIA,  IT.
COPAN ITALIA
BRESCIA,  IT.
Contract Manufacturer;   Manufacturer;  
COPAN ITALIA
BRESCIA,  IT.
COPELAND'S ENT., INC.
SAN LUIS OBISPO,  CA,  US.
Initial Importer;  
COPELAND'S SPORTS
SAN LUIS OBISPO,  CA ,  US.
COPENHAGEN EYES
KOBENHAVN (COPENHAGEN),  DA.
Unregistered Foreign Lister;  
COPENHAGEN EYES
KOBENHAVN (COPENHAGEN),  DA.
COPHARM B.V.
BAAMPRUGGE,  NL.
Unregistered Foreign Lister;  
COPHARM B.V.
BAAMPRUGGE,  NL.
COPIOUMED INTL., INC.
TAIPEI, TAIWAN R.O.C.,  CH.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;   Specification Developer;  
COPIOUMED INTL., INC.
TAIPEI, TAIWAN R.O.C.,  CH.
COPIOUS INTL., INC.
HEYUAN, GUANGDONG PROVINCE,  CH.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
COPIOUS INTL., INC.
HEYUAN, GUANGDONG PROVINCE,  CH.
CORA DISPOSABLES, INC.
BROOKLYN,  NY,  US.
Manufacturer;  
ROBERT BUSSE & CO., INC.
HAUPPAUGE,  NY ,  US.
CORAL BIOTECHNOLOGY
SAN MARCOS,  CA,  US.
Manufacturer;  
CORAL BIOTECHNOLOGY
SAN MARCOS,  CA ,  US.
CORALDENT FORMPACK I.A.P.M. LTDA.
SAO PAULO, SAO PAULO,  BR.
Foreign Exporter;   Contract Manufacturer;  
MARCOS CORAL SCOCATE
SAO PAULO, SAO PAULO,  BR.
CORALLINE S.R.L.
MILANO,  IT.
Manufacturer;  
CORALLINE S.R.L.
MILANO,  IT.
CORAMEX, S.A.
MEXICO, D.F.,  MX.
Manufacturer;  
CORAMEX, S.A.
MEXICO, D.F.,  MX.
CORASOL LLC
ROCKVILLE,  MD,  US.
Initial Importer;  
CORASOL LLC
ROCKVILLE,  MD ,  US.
CORD STICK CORP.
MODESTO,  CA,  US.
Specification Developer;  
CORD STICK CORP.
MODESTO,  CA ,  US.
CORDELL MEDICAL REMARKETING CORP.
RICHMOND,  VA,  US.
Initial Importer;  
CORDELL MEDICAL REMARKETING CORP.
RICHMOND,  VA ,  US.
CORDIGITAL
STILLWATER,  MN,  US.
Initial Importer;  
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
REHOVOT,  IS.

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Last Modified: 29 April 2006
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