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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
ALCOHOL COUNTERMEASURE SYSTEMS CORP.
MISSISSAUGA, ONTARIO,  CA.
Manufacturer;  
ALCOHOL COUNTERMEASURE SYSTEMS, INC.
AURORA,  CO ,  US.
ALCOHOL COUNTERMEASURE SYSTEMS, INC.
AURORA,  CO,  US.
Initial Importer;  
ALCOHOL COUNTERMEASURE SYSTEMS, INC.
AURORA,  CO ,  US.
ALCON GRIESHABER, LTD.
SCHAFFHAUSEN,  SZ.
Manufacturer;   Specification Developer;  
ALCON GRIESHABER, LTD.
SCHAFFHAUSEN,  SZ.
ALCON LABORATORIES IRELAND LTD.
CORK,  EI.
Manufacturer;  
ALCON LABORATORIES IRELAND LTD.
CORK,  EI.
ALCON LABORATORIES, INC.
PUURS,  BE.
Unregistered Foreign Lister;  
ALCON MANUFACTURING, LTD.
FORT WORTH,  TX ,  US.
ALCON MANUFACTURING, LTD.
FORT WORTH,  TX,  US.
Manufacturer;   Specification Developer;  
ALCON MANUFACTURING, LTD.
FORT WORTH,  TX ,  US.
ALCON MANUFACTURING, LTD.
HOUSTON,  TX,  US.
Manufacturer;  
ALCON MANUFACTURING, LTD.
FORT WORTH,  TX ,  US.
ALCON MANUFACTURING, LTD.
HUNTINGTON,  WV,  US.
Manufacturer;  
ALCON MANUFACTURING, LTD.
FORT WORTH,  TX ,  US.
ALCON MANUFACTURING, LTD.
IRVINE,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
ALCON MANUFACTURING, LTD.
FORT WORTH,  TX ,  US.
ALCON MANUFACTURING, LTD.
SINKING SPRING,  PA,  US.
Manufacturer;   Specification Developer;  
ALCON MANUFACTURING, LTD.
FORT WORTH,  TX ,  US.
ALCON REFRACTIVE HORIZONS, INC.
ORLANDO,  FL,  US.
Manufacturer;   Specification Developer;  
ALCON MANUFACTURING, LTD.
FORT WORTH,  TX ,  US.
ALCONOX, INC.
WHITE PLAINS,  NY,  US.
Specification Developer;  
ALCONOX, INC.
WHITE PLAINS,  NY ,  US.
ALCOVE MEDICAL, INC.
SALT LAKE CITY,  UT,  US.
Specification Developer;  
ALCOVE MEDICAL, INC.
SALT LAKE CITY,  UT ,  US.
ALDA ARTHERAPEDIC SYSTEMS, INC.
OTTAWA, ONTARIO,  CA.
Unregistered Foreign Lister;  
ALDA ARTHERAPEDIC SYSTEMS, INC.
OTTAWA, ONTARIO,  CA.
ALDA ARTHERAPEDIC SYSTEMS, INC.
OGDENSBERG,  NY,  US.
Manufacturer;  
ALDA ARTHERAPEDIC SYSTEMS, INC.
OTTAWA, ONTARIO,  CA.
ALDAGEN, INC
DURHAM,  NC,  US.
Manufacturer;   Specification Developer;  
ALDAGEN, INC.
DURHAM,  NC ,  US.
AL-DAN TRADING, INC.
MIAMI,  FL,  US.
Initial Importer;  
AL-DAN TRADING, INC.
MIAMI,  FL ,  US.
ALDEN MEDICAL LLC
WEST SPRINGFIELD,  MA,  US.
Contract Manufacturer;   Manufacturer;  
ALDEN MEDICAL LLC
WEST SPRINGFIELD,  MA ,  US.
ALDEN OPTICAL LABS., INC.
ALDEN,  NY,  US.
Contract Manufacturer;   Manufacturer;  
ALDEN OPTICAL LABS., INC.
ALDEN,  NY ,  US.
ALDEN SURGICAL CO., INC.
MINEOLA,  NY,  US.

ALDEN SURGICAL CO., INC.
MINEOLA,  NY ,  US.
ALDERM N.A., LLC
IRVINE,  CA,  US.
Initial Importer;  
ALDERM N.A., LLC
IRVINE,  CA ,  US.
ALDI, INC.
BATAVIA,  IL,  US.
Initial Importer;  
ALDI, INC.
BATAVIA,  IL ,  US.
ALDI, INC.
OLATHE,  KS,  US.
Initial Importer;  
ALDI, INC.
OLATHE,  KS ,  US.
ALDI, INC.
VALPARAISO,  IN,  US.
Initial Importer;  
ALDI, INC.
VALPARAISO,  IN ,  US.
ALDO U.S. INC.
WILMINGTON,  DE,  US.
Initial Importer;  
ALDO U.S. INC.
WILMINGTON,  DE ,  US.
ALDRICH CHEMICAL CO., INC.
MILWAUKEE,  WI,  US.
Contract Manufacturer;  
ALDRICH CHEMICAL CO., INC.
MILWAUKEE,  WI ,  US.
ALEPH ONE, LTD.
BOTTISHAM, CAMBRIDGE,  UK.
Manufacturer;  
ALEPH ONE, LTD.
BOTTISHAM, CAMBRIDGE,  UK.
ALERCHEK, INC.
PORTLAND,  ME,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ALERCHEK, INC.
PORTLAND,  ME ,  US.
ALERE MEDICAL, INC.
RENO,  NV,  US.
Specification Developer;  
ALERE MEDICAL, INC.
RENO,  NV ,  US.
ALERT CARE, INC.
MILL VALLEY,  CA,  US.
Specification Developer;  
ALERT CARE, INC.
MILL VALLEY,  CA ,  US.
ALERT SERVICES, INC.
SEGUIN,  TX,  US.
Initial Importer;  
ALERT SERVICES, INC.
SEGUIN,  TX ,  US.
ALESSCO, INC.
CHICAGO,  IL,  US.
Initial Importer;  
ALESSCO, INC.
CHICAGO,  IL ,  US.
ALESSI USA, INC.
NEW YORK,  NY,  US.
Initial Importer;  
ALESSI, SPA
CRUSINALLO (VB),  IT.
ALEX INTERNATIONAL, INC.
ARNOLDS PARK,  IA,  US.
Initial Importer;  
ALEX INTERNATIONAL, INC.
ARNOLDS PARK,  IA ,  US.
ALEX ORTHOPEDIC, INC.
GRAND PRAIRIE,  TX,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
ALEX ORTHOPEDIC, INC.
GRAND PRAIRIE,  TX ,  US.
ALEX TSAI & CO., LTD.
TAIPEI,  TW.
Manufacturer;  
ALEX TSAI & CO., LTD.
TAIPEI,  TW.
ALEXANDER TECHNOLOGIES
MASON CITY,  IA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ALEXANDER TECHNOLOGIES
MASON CITY,  IA ,  US.
ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
EDEN PRAIRIE,  MN,  US.
Manufacturer;  
ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
EDEN PRAIRIE,  MN ,  US.
ALFA - MED, LTD.
KIEV, UKRAINE,  UP.
Manufacturer;  
ALFA - MED, LTD.
KIEV, UKRAINE,  UP.
ALFA BIOTECH (UK) LTD.
NR CANTERBURY, KENT,  UK.
Manufacturer;  
ALFA WASSERMANN SPA
BOLOGNA PE,  IT.

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Last Modified: 29 April 2006
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