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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
AAPER ALCOHOL AND CHEMICAL COMPANY
SHELBYVILLE,  KY,  US.
Repackager/Relabeller;  
AAPER ALCOHOL AND CHEMICAL COMPANY
SHELBYVILLE,  KY ,  US.
AARAMCO GENERAL & MEDICAL SUPPLY, INC.
PENSACOLA,  FL,  US.

AARAMCO GENERAL & MEDICAL SUPPLY, INC.
PENSACOLA,  FL ,  US.
AARGUS PLASTICS, INC.
WHEELING,  IL,  US.
Manufacturer;  
AARGUS PLASTICS, INC.
WHEELING,  IL ,  US.
AARON MEDICAL INDUSTRIES
ST. PETERSBURG,  FL,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
BOVIE MEDICAL CORP.
ST. PETERSBURG,  FL ,  US.
AARON THOMAS CO., INC.
GARDEN GROVE,  CA,  US.
Repackager/Relabeller;  
AARON THOMAS CO., INC.
GARDEN GROVE,  CA ,  US.
AARON THOMAS CO., INC.
MEMPHIS,  TN,  US.
Repackager/Relabeller;  
AARON THOMAS CO., INC.
GARDEN GROVE,  CA ,  US.
AAT, ALL ABOUT TOOTH DENTAL SOLUTIONS
GOSHEN,  NY,  US.
Initial Importer;   Repackager/Relabeller;  
AAT, ALL ABOUT TOOTH DENTAL SOLUTIONS
GOSHEN,  NY ,  US.
A-ATHLETIC AND MEDICAL SUPPLY CO., INC.
HOUSTON,  TX,  US.
Initial Importer;  
A-ATHLETIC AND MEDICAL SUPPLY CO., INC.
HOUSTON,  TX ,  US.
AATZ, INC.
ABIKO, CHIBA,  JA.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AATZ, INC.
ABIKO, CHIBA,  JA.
AAXIS MEDICAL PRODUCTS (SUZHOU) CO., LTD.
SUZHOU,  CH.
Manufacturer;  
TOLLOT PTY.LTD.(AAXIS PACIFIC)
SEVEN HILLS, NSW,  AS.
AAZIN OPTICAL CO.
MONROE,  CT,  US.
Initial Importer;  
AZIN OPTICAL CO., LTD.
KUMJUNG-GU, PUSAN,  KS.
AAZO ENTERPRISES
CHICAGO,  IL,  US.
Initial Importer;  
AAZO ENTERPRISES
CHICAGO,  IL ,  US.
AB ARDENT
MARSTA,  SW.
Manufacturer;  
AB ARDENT
MARSTA,  SW.
AB BIODISK
SOLNA,  SW.
Manufacturer;  
AB BIODISK
SOLNA,  SW.
AB BIODISK NORTH AMERICA, INC.
PISCATAWAY,  NJ,  US.
Initial Importer;  
AB BIODISK NORTH AMERICA, INC.
PISCATAWAY,  NJ ,  US.
AB GERMA,SWEDEN
KRISTIANSTAD,  SW.
Unregistered Foreign Lister;  
AB GERMA,SWEDEN
KRISTIANSTAD,  SW.
AB OPTICS, INC.
GRESHAM,  OR,  US.
Initial Importer;  
AB OPTICS, INC.
GRESHAM,  OR ,  US.
AB SORBINCO
MOLNLYCKE,  SW.
Manufacturer;   Specification Developer;  
AB SORBINCO
MOLNLYCKE,  SW.
AB TECH CORP.
CASPER,  WY,  US.
Initial Importer;  
AB TECH CORP.
CASPER,  WY ,  US.
AB VARNAMO GUMMIFABRIK
331 01 VARNAMO,  SW.
Manufacturer;  
AB VARNAMO GUMMIFABRIK
331 01 VARNAMO,  SW.
AB2 MEDICAL PRODUCTS, LLP
THE WOODLANDS,  TX,  US.
Manufacturer;  
AB2 MEDICAL PRODUCTS, LLP
THE WOODLANDS,  TX ,  US.
ABA PREFECTURE FOREIGN TRADE & RELATIONS CORP.
CHENGDU SICHUAN,  CH.
Unregistered Foreign Lister;  
ABA PREFECTURE FOREIGN TRADE & RELATIONS CORP.
CHENGDU SICHUAN,  CH.
ABACUS DIAGNOSTICS
WEST HILLS,  CA,  US.
Repackager/Relabeller;  
ABACUS DIAGNOSTICS
WEST HILLS,  CA ,  US.
ABARE ENT., INC.
FORSYTH,  GA,  US.
Manufacturer;  
ABARE ENT., INC.
FORSYTH,  GA ,  US.
ABATEMENT TECHNOLOGIES, INC.
DULUTH,  GA,  US.
Initial Importer;   Specification Developer;  
ABATEMENT TECHNOLOGIES, LTD.
FORT ERIE, ONTARIO,  CA.
ABATEMENT TECHNOLOGIES, LTD.
FORT ERIE, ONTARIO,  CA.
Manufacturer;  
ABATEMENT TECHNOLOGIES, LTD.
FORT ERIE, ONTARIO,  CA.
ABAXIS, INC.
UNION CITY,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ABAXIS, INC.
UNION CITY,  CA ,  US.
ABB OPTICAL OF NORTH AMERICA
MARSHFIELD,  MA,  US.
Initial Importer;  
ABB OPTICAL OF NORTH AMERICA
FT. LAUDERDALE,  FL ,  US.
ABB OPTICAL OF NORTH AMERICA
FT. LAUDERDALE,  FL,  US.
Initial Importer;  
BUCHMANN OPTICAL INDUSTRIES
KAPELLEN,  BE.
ABBA & GREAT DEVELOPMENT INDUSTRIAL, INC.
TAIPEI,  TW.
Manufacturer;  
ABBA & GREAT DEVELOPMENT INDUSTRIAL, INC.
TAIPEI,  TW.
ABBA WHEELCHAIRS, LLC
HONOLULU,  HI,  US.
Initial Importer;  
ABBA WHEELCHAIRS, LLC
HONOLULU,  HI ,  US.
ABBAS' GRACE
MANCHESTER,  NH,  US.
Manufacturer;  
ABBAS' GRACE
MANCHESTER,  NH ,  US.
ABBEY COLOR, INC.
PHILADELPHIA,  PA,  US.
Manufacturer;  
ABBEY COLOR, INC.
PHILADELPHIA,  PA ,  US.
ABBOTT ASSOCIATES, INC.
MILFORD,  CT,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ABBOTT ASSOCIATES, INC.
MILFORD,  CT ,  US.
ABBOTT DIABETES CARE INC.
ALAMEDA,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT DIABETES CARE LIMITED
ABINGDON, OXON,  UK.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT DIABETES CARE LIMITED
WITNEY OXON,  UK.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
BARCELONETA,  PR,  US.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT HOSPITALS LTD.
ITABO, HAINA SAN CRISTOBAL,  DR.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT IRELAND
SLIGO,  EI.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.

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Last Modified: 29 April 2006
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