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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
APO DIAGNOSTICS, INC.
ONTARIO,  CA.
Unregistered Foreign Lister;  
APO DIAGNOSTICS, INC.
ONTARIO,  CA.
APO HEALTH, INC.
OCEANSIDE,  NY,  US.
Initial Importer;   Repackager/Relabeller;  
APO HEALTH, INC.
OCEANSIDE,  NY ,  US.
APOGEE MEDICAL, LLC
YOUNGSVILLE,  NC,  US.
Contract Manufacturer;   Manufacturer;  
HOLLISTER, INC.
LIBERTYVILLE,  IL ,  US.
APOLLO ADVANCED TECNNOLOGY, LLC
KELLER,  TX,  US.
Initial Importer;  
APOLLO ADVANCED TECNNOLOGY, LLC
KELLER,  TX ,  US.
APOLLO BIOMEDICALS CORP.
BURLINGAME,  CA,  US.
Manufacturer;  
APOLLO BIOMEDICALS CORP.
BURLINGAME,  CA ,  US.
APOLLO CORP.
SOMERSET,  WI,  US.
Manufacturer;  
APOLLO CORP.
SOMERSET,  WI ,  US.
APOLLO FLUID DYNAMICS
TORRANCE,  CA,  US.
Manufacturer;  
APOLLO FLUID DYNAMICS
TORRANCE,  CA ,  US.
APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD.
MELBOURNE, VICTORIA,  AS.
Manufacturer;  
APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD.
MELBOURNE, VICTORIA,  AS.
APOLLO MFG., INC.
WILLOUGHBY,  OH,  US.
Contract Manufacturer;  
APOLLO MFG., INC.
WILLOUGHBY,  OH ,  US.
APOLO, INC.
CATANO,  PR,  US.
Initial Importer;  
APOLO, INC.
SAN JUAN,  PR ,  US.
APOS SPORTS & MEDICAL TECHNOLOGIES
DIMONA,  IS.
Manufacturer;  
APOS SPORTS & MEDICAL TECHNOLOGIES
DIMONA,  IS.
APOTEKET PRODUKTION & LABORATORIER
UMEA,  SW.
Contract Manufacturer;  
APOTEKET AB
STOCKHOLM,  SW.
APOTEX, INC.
RICHMOND HILL, ONTARIO,  CA.
Contract Manufacturer;   Contract Sterilizer;  
APOTEX, INC.
WESTON, ONTARIO,  CA.
APOTHECARIES SUNDRIES MFG. CO.
NEW DELHI,  IN.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
APOTHECARIES SUNDRIES MFG. CO.
NEW DELHI,  IN.
APOTHECARY PRODUCTS, INC.
BURNSVILLE,  MN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
APOTHECARY PRODUCTS, INC.
BURNSVILLE,  MN ,  US.
APOTHECARY PRODUCTS, INC.
ST. CHARLES,  MI,  US.
Manufacturer;   Repackager/Relabeller;  
APOTHECARY PRODUCTS, INC.
BURNSVILLE,  MN ,  US.
APOTHECARY PRODUCTS, INC.
ST. CHARLES,  MI,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
APOTHECARY PRODUCTS, INC.
BURNSVILLE,  MN ,  US.
APOZA ENTERPRISE CO. LTD.
TAIPEI HSIEN,  TW.
Manufacturer;  
APOZA ENTERPRISE CO. LTD.
TAIPEI HSIEN,  TW.
APPALACHIAN ELECTRONIC INSTRUMENTS, INC.
RONCEVERTE,  WV,  US.
Contract Manufacturer;  
APPALACHIAN ELECTRONIC INSTRUMENTS, INC.
RONCEVERTE,  WV ,  US.
APPAREL EXPORT INTERNATIONAL LIMITED
KINGSTON, JAMAICA,  JM.
Foreign Exporter;   Manufacturer;  
ENCOMPASS GROUP, LLC.
MCDONOUGH,  GA ,  US.
APPASAMY MICRO SURGICAL INSTRUMENTS
CALCUTTA,  IN.
Unregistered Foreign Lister;  
APPASAMY MICRO SURGICAL INSTRUMENTS
CALCUTTA,  IN.
APPASAMY OCULAR DEVICES LTD.
PONDICHERY, PONDICHERY,  IN.
Manufacturer;  
APPASAMY OCULAR DEVICES LTD.
PONDICHERY, PONDICHERY,  IN.
APPLE CONVERTING, INC.
NORWICH,  NY,  US.
Contract Manufacturer;  
APPLE CONVERTING, INC.
NORWICH,  NY ,  US.
APPLE MEDICAL CORP.
MARLBORO,  MA,  US.
Manufacturer;   Specification Developer;  
APPLE MEDICAL CORP.
MARLBORO,  MA ,  US.
APPLE MEDICAL, INC.
DENVER,  CO,  US.

APPLE MEDICAL, INC.
DENVER,  CO ,  US.
APPLE OPTICAL CO.
FALLS CHURCH,  VA,  US.
Initial Importer;  
APPLE OPTICAL CO.
FALLS CHURCH,  VA ,  US.
APPLERA HOLDING B.V.
SINGAPORE,  SN.
Contract Manufacturer;  
APPLERA CORP.
NORWALK,  CT ,  US.
APPLETON MEDICAL SERVICES, INC.
FLORISSANT,  MO,  US.
Initial Importer;  
APPLETON MEDICAL SERVICES, INC.
FLORISSANT,  MO ,  US.
APPLICA CONSUMER PRODUCTS, INC.
MIRAMAR,  FL,  US.
Initial Importer;  
APPLICA CONSUMER PRODUCTS, INC.
MIRAMAR,  FL ,  US.
APPLICA DURABLE MANUFACTURING LIMITED
AN DIST.,SHENZHEN,GUANG DONG,  CH.
Unregistered Foreign Lister;  
APPLICA DURABLE MANUFACTURING LIMITED
AN DIST.,SHENZHEN,GUANG DONG,  CH.
APPLIED BIOSYSTEMS
FOSTER CITY,  CA,  US.
Initial Importer;   Manufacturer;  
APPLERA CORP.
NORWALK,  CT ,  US.
APPLIED BIOTECH
SAN DIEGO,  CA,  US.
Manufacturer;  
INVERNESS MEDICAL INNOVATIONS, INC.
WALTHAM,  MA ,  US.
APPLIED BIOTECH, INC.
SAN DIEGO,  CA,  US.
Manufacturer;  
INVERNESS MEDICAL INNOVATIONS, INC.
WALTHAM,  MA ,  US.
APPLIED CARDIAC SYSTEMS
LAGUNA HILLS,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
APPLIED CARDIAC SYSTEMS
LAGUNA HILLS,  CA ,  US.
APPLIED COMPOSITE TECHNOLOGY
FAYETTE,  UT,  US.
Contract Manufacturer;   Manufacturer;  
APPLIED COMPOSITE TECHNOLOGY
FAYETTE,  UT ,  US.
APPLIED DENTAL INC.
MOUNTAIN VIEW,  CA,  US.
Specification Developer;  
APPLIED DENTAL INC.
MOUNTAIN VIEW,  CA ,  US.
APPLIED DIABETES RESEARCH, INC.
CARROLLTON,  TX,  US.
Specification Developer;  
APPLIED DIABETES RESEARCH, INC.
CARROLLTON,  TX ,  US.
APPLIED DNA TECHNOLOGIES, INC.
CARLSBAD,  CA,  US.
Initial Importer;  
APPLIED DNA TECHNOLOGIES, INC.
CARLSBAD,  CA ,  US.
APPLIED IMAGING CORP.
SAN JOSE,  CA,  US.
Initial Importer;   Manufacturer;  
APPLIED IMAGING CORP.
SAN JOSE,  CA ,  US.
APPLIED INVENTION
HILLSDALE,  NY,  US.
Manufacturer;  
JULIUS M.J. MADEY
HILLSDALE,  NY ,  US.

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Last Modified: 29 April 2006
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