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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
ASTRALITE CORP.
SOMERSET,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
ASTRALITE CORP.
SOMERSET,  CA ,  US.
ASTRAZENECA UK LTD.
LONDON, ENGLAND,  UK.
Specification Developer;  
ASTRAZENECA UK LTD.
LONDON, ENGLAND,  UK.
ASTRIDGE INT'L
GRAND ISLAND,  NY,  US.
Initial Importer;  
ASTRIDGE INT'L
GRAND ISLAND,  NY ,  US.
ASTRO INSTRUMENTATION LLC
STRONGSVILLE,  OH,  US.
Contract Manufacturer;  
ASTRO INSTRUMENTATION L.L.C
STRONGSVILLE,  OH ,  US.
ASTRO MEDICAL DEVICES
MENTOR,  OH,  US.
Contract Manufacturer;  
ASTRO MEDICAL DEVICES
MENTOR,  OH ,  US.
ASTRO MODEL DEVELOPMENT CORP.
EASTLAKE,  OH,  US.
Contract Manufacturer;  
ASTRO MODEL DEVELOPMENT CORP.
EASTLAKE,  OH ,  US.
ASTRO-MED, INC.
WEST WARWICK,  RI,  US.
Initial Importer;   Manufacturer;  
ASTRO-MED, INC.
WEST WARWICK,  RI ,  US.
ASTRON CLINICA LIMITED
CAMBRIDGE,  UK.
Manufacturer;   Specification Developer;  
ASTRON CLINICA LIMITED
CAMBRIDGE,  UK.
ASTRON DENTAL CORPORATION
LAKE ZURICH,  IL,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ASTRON DENTAL CORPORATION
LAKE ZURICH,  IL ,  US.
ASTRON INTERNATIONAL INC.
NAPLES,  FL,  US.
Contract Manufacturer;   Manufacturer;  
ASTRON INTERNATIONAL INC.
NAPLES,  FL ,  US.
ASYS HITECH GMBH
EUGENDORF,  AU.
Manufacturer;  
ASYS HITECH GMBH
EUGENDORF,  AU.
AT LAST NATURALS, INC.
VALHALLA,  NY,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
AT LAST NATURALS, INC.
VALHALLA,  NY ,  US.
A-T SURGICAL MFG. CO., INC.
HOLYOKE,  MA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
A-T SURGICAL MFG. CO., INC.
HOLYOKE,  MA ,  US.
ATAGO CO.
ITABASHI-KU, TOKYO,  JA.
Manufacturer;  
ATAGO CO., LTD.
ITABASHI-KU, TOKYO,  JA.
ATAGO U.S.A., INC.
BELLEVUE,  WA,  US.
Initial Importer;  
ATAGO CO., LTD.
ITABASHI-KU, TOKYO,  JA.
ATC TECHNOLOGIES, INC.
WILMINGTON,  MA,  US.
Contract Manufacturer;   Manufacturer;  
ATC TECHNOLOGIES, INC.
WILMINGTON,  MA ,  US.
ATC, INC.
FAIRFAX,  VA,  US.
Initial Importer;  
ATC, INC.
FAIRFAX,  VA ,  US.
ATCO PLASTICS, INC.
PLAINVILLE,  MA,  US.
Contract Manufacturer;  
ATCO PLASTICS, INC.
PLAINVILLE,  MA ,  US.
ATCOR MEDICAL
WEST RYDE NSW,  AS.
Manufacturer;  
ATCOR MEDICAL
WEST RYDE NSW,  AS.
ATE NUTRITIONALS, INC.
BROOKLYN,  NY,  US.
Initial Importer;  
ATE NUTRITIONALS, INC.
BROOKLYN,  NY ,  US.
ATECS CORP.
HONOLULU,  HI,  US.

ATECS CORP.
HONOLULU,  HI ,  US.
ATEK MEDICAL MANUFACTURING
GRAND RAPIDS,  MI,  US.
Contract Manufacturer;  
ATEK MEDICAL MANUFACTURING, LLC
GRAND RAPIDS,  MI ,  US.
ATELIER AM AMMERSEE
INNING AM AMMERSEE,  GM.
Unregistered Foreign Lister;  
ATELIER AM AMMERSEE
INNING AM AMMERSEE,  GM.
ATELIER AM AMMERSEE, EYEWEAR AND FASHION
INNING AM AMMERSEE,  GM.
Unregistered Foreign Lister;  
ATELIER AM AMMERSEE, EYEWEAR AND FASHION
INNING AM AMMERSEE,  GM.
ATELIER MARCUS MARIENFELD
BRIG,  SZ.
Unregistered Foreign Lister;  
ATELIER MARCUS MARIENFELD
BRIG,  SZ.
ATEN, INC.
WEST PALM BEACH,  FL,  US.
Initial Importer;  
ATEN, INC.
WEST PALM BEACH,  FL ,  US.
ATG ASSOC., INC.
NORTH QUINCY,  MA,  US.
Initial Importer;  
ATG ASSOC., INC.
NORTH QUINCY,  MA ,  US.
ATG-MA, INC.
RAYNHAM,  MA,  US.
Initial Importer;  
ATG-MA, INC.
RAYNHAM,  MA ,  US.
ATHCO
LENEXA,  KS,  US.

ATHCO
LENEXA,  KS ,  US.
ATHENA BEAUTY INC,
EDISON,  NJ,  US.
Initial Importer;  
ATHENA BEAUTY INC,
EDISON,  NJ ,  US.
ATHENA FEMININE TECHNOLOGIES, INC.
ORINDA,  CA,  US.
Specification Developer;  
ATHENA FEMININE TECHNOLOGIES, INC.
ORINDA,  CA ,  US.
ATHENA TECHNOLOGY, INC.
FORT WAYNE,  IN,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
ATHENA TECHNOLOGY, INC.
FORT WAYNE,  IN ,  US.
ATHLE SURGICO
SIALKOT & PUNJAB,  PK.
Manufacturer;  
ATHLE SURGICO
SIALKOT & PUNJAB,  PK.
ATHOME MEDICAL, INC.
MORRIS PLAINS,  NJ,  US.
Repackager/Relabeller;  
AHSIC
MORRIS PLAINS,  NJ ,  US.
ATHOME MEDICAL, INC.
SO. HACKENSACK,  NJ,  US.
Repackager/Relabeller;  
AHSIC
MORRIS PLAINS,  NJ ,  US.
ATICO INTERNATIONAL USA, INC.
FT. LAUDERDALE,  FL,  US.
Initial Importer;  
ATICO INTERNATIONAL USA, INC.
FT. LAUDERDALE,  FL ,  US.
ATISTER ENT., LTD.
KOWLOON,  HK.
Manufacturer;  
ATISTER ENT., LTD.
KOWLOON,  HK.
ATLANTA ARMY NAVY STORE, INC.
MARIETTA,  GA,  US.
Initial Importer;  
ATLANTA ARMY NAVY STORE, INC.
MARIETTA,  GA ,  US.
ATLANTA DENTAL SUPPLY
ATLANTA,  GA,  US.
Initial Importer;  
ATLANTA DENTAL SUPPLY
ATLANTA,  GA ,  US.
ATLANTA HEALTHCARE SERVICES
LAWRENCEVILLE,  GA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ATLANTA HEALTHCARE SERVICES
ATLANTA,  GA ,  US.

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Last Modified: 29 April 2006
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