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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
A-MEDICAL SERVICE
AKRON,  OH,  US.
Initial Importer;  
A-MEDICAL SERVICE
AKRON,  OH ,  US.
AMEDITECH, INC.
SAN DIEGO,  CA,  US.
Manufacturer;  
AMEDITECH, INC.
SAN DIEGO,  CA ,  US.
AMEE SALES, INC.
NEW YORK,  NY,  US.
Initial Importer;  
AMEE SALES, INC.
NEW YORK,  NY ,  US.
AMENITIQUE, INC.
TAMPA,  FL,  US.
Initial Importer;  
AMENITIQUE, INC.
TAMPA,  FL ,  US.
AMENITY SOLUTIONS CORP. LTD.
KWAI CHUNG, N.T. HONG KONG,  CH.
Foreign Exporter;  
AMENITY SOLUTIONS CORP. LTD.
KWAI CHUNG, N.T. HONG KONG,  CH.
AMENNI INC.
FT. LAUDERDALE,  FL,  US.
Initial Importer;  
AMENNI INC.
FT. LAUDERDALE,  FL ,  US.
AMER TRADERS
SIALKOT, PUNJAB,  PK.
Manufacturer;  
AMER TRADERS
SIALKOT, PUNJAB,  PK.
AMERASIA CORPORATION
QINGYUAN, GUANGDONG,  CH.
Contract Manufacturer;  
AMERASIA CORPORATION
QINGYUAN, GUANGDONG,  CH.
AMERCARE PRODUCTS, INC.
SEATTLE,  WA,  US.
Initial Importer;  
AMERCARE PRODUCTS, INC.
SEATTLE,  WA ,  US.
AMERCARE, INC.
CHARLESTON,  SC,  US.
Initial Importer;  
AMERCARE, INC.
CHARLESTON,  SC ,  US.
AMERGLO PRODUCTS, INC.
MONMOUTH JUNCTION,  NJ,  US.
Initial Importer;  
AMERGLO PRODUCTS, INC.
MONMOUTH JUNCTION,  NJ ,  US.
AMERICA GREEN DENT., MFG.
LOS ANGELES,  CA,  US.
Manufacturer;  
AMERICA GREEN DENT., MFG.
LOS ANGELES,  CA ,  US.
AMERICA SPORT OPTICAL
TORRANCE,  CA,  US.
Initial Importer;  
AMERICA SPORT OPTICAL
TORRANCE,  CA ,  US.
AMERICAN ACCESSORIES INTL., LLC.
KNOXVILLE,  TN,  US.
Initial Importer;   Specification Developer;  
AMERICAN ACCESSORIES INTL., LLC.
KNOXVILLE,  TN ,  US.
AMERICAN AMENITIES
WOODINVILLE,  WA,  US.
Initial Importer;  
AMERICAN AMENITIES
WOODINVILLE,  WA ,  US.
AMERICAN AMENITIES, INC.
WOODINVILLE,  WA,  US.
Initial Importer;  
AMERICAN AMENITIES, INC.
WOODINVILLE,  WA ,  US.
AMERICAN AUSTRALIAN MEDICAL, INC.
BUFFALO,  NY,  US.
Initial Importer;  
PAXTON WONG, GO MEDICAL INDUSTRIES PTY LTD.
MAROUBRA, NSW,  AS.
AMERICAN BANTEX CORP.
BURLINGAME,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
AMERICAN BANTEX CORP.
BURLINGAME,  CA ,  US.
AMERICAN BIO MEDICA CORP.
KINDERHOOK,  NY,  US.
Manufacturer;   Repackager/Relabeller;  
AMERICAN BIO MEDICA CORP.
KINDERHOOK,  NY ,  US.
AMERICAN BIO MEDICA CORP.
LOGAN TOWNSHIP,  NJ,  US.
Contract Manufacturer;   Manufacturer;  
AMERICAN BIO MEDICA CORP.
KINDERHOOK,  NY ,  US.
AMERICAN BIOCHEMICAL & PHARMACEUTICAL CORP.
JAMAICA,  NY,  US.
Initial Importer;  
AMERICAN BIOCHEMICAL & PHARMACEUTICAL CORP.
JAMAICA,  NY ,  US.
AMERICAN BIOLOGICAL TECHNOLOGIES, INC.
SEGUIN,  TX,  US.
Contract Manufacturer;   Manufacturer;  
AMERICAN BIOLOGICAL TECHNOLOGIES, INC.
SEGUIN,  TX ,  US.
AMERICAN BIO-MEDICAL SERVICE CORP.
SAN DIMAS,  CA,  US.
Remanufacturer;  
AMERICAN BIO-MEDICAL SERVICE CORP.
SAN DIMAS,  CA ,  US.
AMERICAN BIOMEDICAL, INC.
TULSA,  OK,  US.
Contract Manufacturer;   Manufacturer;  
AMERICAN BIOMEDICAL, INC.
TULSA,  OK ,  US.
AMERICAN BIORGANICS, INC.
NIAGARA FALLS,  NY,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMERICAN BIORGANICS, INC.
NIAGARA FALLS,  NY ,  US.
AMERICAN BIOSURGICAL, INC.
NORCROSS,  GA,  US.
Initial Importer;   Specification Developer;  
AMERICAN BIOSURGICAL, INC.
NORCROSS,  GA ,  US.
AMERICAN BODY ART
DAYTONA BEACH SHORES,  FL,  US.
Initial Importer;  
AMERICAN BODY ART
DAYTONA BEACH SHORES,  FL ,  US.
AMERICAN BREAST CARE LP
MARIETTA,  GA,  US.
Manufacturer;  
AMERICAN BREAST CARE LP
MARIETTA,  GA ,  US.
AMERICAN CANCER SOCIETY
NEW YORK,  NY,  US.
Initial Importer;  
AMERICAN CANCER SOCIETY
NEW YORK,  NY ,  US.
AMERICAN CARDIAC ABLATION, INC.
TAUNTON,  MA,  US.
Contract Manufacturer;   Manufacturer;  
AMERICAN CARDIAC ABLATION, INC.
TAUNTON,  MA ,  US.
AMERICAN CARE
RICHFIELD,  MN,  US.
Manufacturer;  
AMERICAN CARE
RICHFIELD,  MN ,  US.
AMERICAN CARE USA STABILIZER, INC.
ANDOVER,  MN,  US.
Specification Developer;  
AMERICAN CARE USA STABILIZER, INC.
ANDOVER,  MN ,  US.
AMERICAN CAROLINA STAMPING
PENROSE,  NC,  US.
Contract Manufacturer;  
MCJAST
PENROSE,  NC ,  US.
AMERICAN CATHETER CORP
OCALA,  FL,  US.
Manufacturer;  
AMERICAN CATHETER CORP
OCALA,  FL ,  US.
AMERICAN CHINESE MEDICINE HEALTH CENTER
SANTA CRUZ,  CA,  US.
Initial Importer;  
AMERICAN CHINESE MEDICINE HEALTH CENTER
SANTA CRUZ,  CA ,  US.
AMERICAN COIL SPRING CO.
MUSKEGON,  MI,  US.
Manufacturer;  
AMERICAN COIL SPRING CO.
MUSKEGON,  MI ,  US.
AMERICAN COMB CORP.
PATERSON,  NJ,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
AMERICAN COMB CORP.
PATERSON,  NJ ,  US.
AMERICAN CONSOLIDATED MFG. CO., INC.
WEST CONSHOHOCKEN,  PA,  US.
Manufacturer;  
AMERICAN CONSOLIDATED MFG. CO., INC.
WEST CONSHOHOCKEN,  PA ,  US.
AMERICAN CONSUMER PRODUCTS, LLC
FARMINGTON HILLS,  MI,  US.
Initial Importer;  
AMERICAN CONSUMER PRODUCTS, LLC
FARMINGTON HILLS,  MI ,  US.
AMERICAN CONTACT LENS, INC.
SAN DIEGO,  CA,  US.
Initial Importer;  
AMERICAN CONTACT LENS, INC.
SAN DIEGO,  CA ,  US.

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Last Modified: 29 April 2006
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