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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
ACCESSORY BRANDS, INC.
WINSTON-SALEM,  NC,  US.
Initial Importer;  
ACCESSORY BRANDS, INC.
WINSTON-SALEM,  NC ,  US.
ACCESSORY NETWORK GROUP LLC
NEW YORK,  NY,  US.
Initial Importer;  
ACCESSORY NETWORK GROUP LLC
NEW YORK,  NY ,  US.
ACCLAIM MEDICAL MANUFACTURING LLC
CAMDEN,  NJ,  US.
Initial Importer;   Manufacturer;  
ACCLAIM MEDICAL MANUFACTURING LLC
CAMDEN,  NJ ,  US.
ACCLARENT, INC.
MENLO PARK,  CA,  US.
Specification Developer;  
ACCLARENT, INC.
MENLO PARK,  CA ,  US.
ACCODENT
CUPERTINO,  CA,  US.
Initial Importer;  
ACCODENT
CUPERTINO,  CA ,  US.
ACCOMMODATA CORPORATION
CLEVELAND,  OH,  US.
Manufacturer;  
ACCOMMODATA CORPORATION
CLEVELAND,  OH ,  US.
ACCOMPANY SURGICAL
SIALKOT,  PK.
Manufacturer;  
ACCOMPANY SURGICAL
SIALKOT-1,  PK.
ACCOR, INC.
CLEVELAND HEIGHTS,  OH,  US.
Manufacturer;  
ACCOR, INC.
CLEVELAND HEIGHTS,  OH ,  US.
ACCOUTREMENTS
MUKILTEO,  WA,  US.
Initial Importer;  
ACCOUTREMENTS
MUKILTEO,  WA ,  US.
ACCRA PAC, INC.
ELKHART,  IN,  US.
Contract Manufacturer;  
ACCRA PAC, INC.
ELKHART,  IN ,  US.
ACCU BITE, INC.
WILLIAMSTON,  MI,  US.
Initial Importer;  
ACCU BITE, INC.
WILLIAMSTON,  MI ,  US.
ACCUBIOTECH COMPANY, LIMITED
BEIJING,  TW.
Manufacturer;  
ACCUBIOTECH COMPANY, LIMITED
BEIJING,  TW.
ACCUCARE HOME MEDICAL EQUIP. INC.
WESTLAKE,  OH,  US.
Initial Importer;  
ACCUCARE HOME MEDICAL EQUIP. INC.
WESTLAKE,  OH ,  US.
ACCU-DENT RESEARCH & DEVELOPMENT CO.
MEDFORD,  OR,  US.
Manufacturer;   Specification Developer;  
ACCU-DENT RESEARCH & DEVELOPMENT CO.
MEDFORD,  OR ,  US.
ACCUFAST, INC.
WINNIPEG, MANITOBA,  CA.
Manufacturer;  
ACCUFAST, INC.
WINNIPEG, MANITOBA,  CA.
ACCU-FIT, INC.
SAN MATEO,  CA,  US.
Initial Importer;  
ACCU-FIT, INC.
SAN MATEO,  CA ,  US.
ACCUFITNESS, LLC.
GREENWOOD VILLAGE,  CO,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ACCUFITNESS, LLC.
GREENWOOD VILLAGE,  CO ,  US.
ACCUFIX RESEARCH INSTITUTE
PARKER,  CO,  US.
Repackager/Relabeller;  
ACCUFIX RESEARCH INSTITUTE
PARKER,  CO ,  US.
ACCU-GLASS
ST. LOUIS,  MO,  US.
Initial Importer;   Manufacturer;  
BECTON, DICKINSON & CO.
FRANKLIN LAKES,  NJ ,  US.
ACCUHEALTH, INC.
BRONX,  NY,  US.

ACCUHEALTH, INC.
BRONX,  NY ,  US.
ACCUIMAGE DIAGNOSTICS CORP.
SOUTH SAN FRANCISCO,  CA,  US.
Manufacturer;  
ACCUIMAGE DIAGNOSTICS CORP.
SOUTH SAN FRANCISCO,  CA ,  US.
ACCULASER/PHYSICIANS INSURANCE
CHICAGO,  IL,  US.
Initial Importer;  
ACCULASER/PHYSICIANS INSURANCE
CHICAGO,  IL ,  US.
ACCU-LENS, INC.
LAKEWOOD,  CO,  US.
Contract Manufacturer;  
ACCU-LENS, INC.
LAKEWOOD,  CO ,  US.
ACCU-LINE PRODUCTS, INC.
HYANNIS,  MA,  US.
Specification Developer;   Repackager/Relabeller;  
ACCU-LINE PRODUCTS, INC.
HYANNIS,  MA ,  US.
ACCU-MEASURE, LLC.
GREENWOOD VILLAGE,  CO,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ACCU-MEASURE, LLC.
GREENWOOD VILLAGE,  CO ,  US.
ACCUMED SYSTEMS, INC.
ANN ARBOR,  MI,  US.
Manufacturer;  
ACCUMED SYSTEMS, INC.
ANN ARBOR,  MI ,  US.
ACCU-MED TECHNOLOGIES, INC.
BUFFALO,  NY,  US.
Contract Manufacturer;  
ACCU-MED TECHNOLOGIES, INC.
BUFFALO,  NY ,  US.
ACCUMEDIX, INC.
GRAYSLAKE,  IL,  US.
Contract Manufacturer;  
ACCUMEDIX, INC.
GRAYSLAKE,  IL ,  US.
ACCUMETRICS, INC.
SAN DIEGO,  CA,  US.
Manufacturer;  
ACCUMETRICS, INC.
SAN DIEGO,  CA ,  US.
ACCUMIN DIAGNOSTICS, INC.
NEW YORK,  NY,  US.
Manufacturer;  
KERYX BIOPHARMACEUTICALS
NEW YORK,  NY ,  US.
ACCUPAC, INC.
MAINLAND,  PA,  US.
Contract Manufacturer;  
ACCUPAC, INC.
MAINLAND,  PA ,  US.
ACCUPHARMA RESEARCH & SCIENTIFIC CONSULTING, INC.
HUMACAO,  PR,  US.
Manufacturer;  
ACCUPHARMA RESEARCH & SCIENTIFIC CONSULTING, INC.
HUMACAO,  PR ,  US.
ACCURATE CHEMICAL & SCIENTIFIC CORP.
WESTBURY,  NY,  US.
Initial Importer;  
ACCURATE CHEMICAL & SCIENTIFIC CORP.
WESTBURY,  NY ,  US.
ACCURATE INDUSTRIES
CHICAGO,  IL,  US.
Initial Importer;  
ACCURATE INDUSTRIES
CHICAGO,  IL ,  US.
ACCURATE MACHINES & TOOL CO., INC.
ALBUQUERQUE,  NM,  US.
Contract Manufacturer;  
ACCURATE MACHINES & TOOL CO., INC.
ALBUQUERQUE,  NM ,  US.
ACCURATE MEDICAL DIAGNOSTICS
ALAMEDA,  CA,  US.
Initial Importer;  
ACCURATE MEDICAL DIAGNOSTICS
ALAMEDA,  CA ,  US.
ACCURATE SET, INC.
NEWARK,  NJ,  US.
Manufacturer;  
ACCURATE SET, INC.
NEWARK,  NJ ,  US.
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
WESTBURY,  NY,  US.
Initial Importer;  
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
WESTBURY,  NY ,  US.
ACCURAY SURGICALS, LTD.
KARACHI,  PK.
Manufacturer;  
ACCURAY SURGICALS, LTD.
KARACHI,  PK.
ACCURAY, INC.
SUNNYVALE,  CA,  US.
Manufacturer;  
ACCURAY, INC.
SUNNYVALE,  CA ,  US.

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Last Modified: 29 April 2006
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