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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-JU INDUSTRY
DAEGU,  KS.
Foreign Exporter;  
A-JU INDUSTRY SANG IL, PARK
DAEGU,  KS.
AJURVEDA JOINT STOCK COMPANY
MOSCOW,  RS.
Manufacturer;  
AJURVEDA JOINT STOCK COMPANY
MOSCOW,  RS.
AK SOLUTIONS USA, LLC
PALISADES PARK,  NJ,  US.
Initial Importer;  
AK SOLUTIONS USA, LLC
PALISADES PARK,  NJ ,  US.
AK USA LLC
NORTH LAS VEGAS,  NV,  US.
Initial Importer;  
AK USA LLC
NORTH LAS VEGAS,  NV ,  US.
AK WHOLESALE, INC.
HENDERSON,  NV,  US.
Initial Importer;  
AK WHOLESALE, INC.
HENDERSON,  NV ,  US.
AKA SUPPLY
HUMBLE,  TX,  US.
Initial Importer;  
AKA SUPPLY
HUMBLE,  TX ,  US.
AKADEMA INC
GARFIELD,  NJ,  US.
Initial Importer;  
AKADEMA INC
GARFIELD,  NJ ,  US.
AKASHA GROUP, LLC
ORINDA,  CA,  US.
Initial Importer;  
AKASHA GROUP, LLC
ORINDA,  CA ,  US.
AKERS BIOSCIENCES, INC.
THOROFARE,  NJ,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
AKERS BIOSCIENCES, INC.
THOROFARE,  NJ ,  US.
AKERS INDUSTRIES, INC.
DEDHAM,  MA,  US.
Initial Importer;  
AKERS INDUSTRIES, INC.
DEDHAM,  MA ,  US.
AKHTAR BROTHERS ENTERPRISES INC
PINE BUSH,  NY,  US.
Initial Importer;  
AKHTAR BROTHERS ENTERPRISES INC
PINE BUSH,  NY ,  US.
AKISU MACHINERY
TAI-CHUNG HSIEN,  TW.
Unregistered Foreign Lister;  
AKISU MACHINERY
TAI-CHUNG HSIEN,  TW.
AKITA SUMITOMO BAKELITE CO., LTD.
AKITA,  JA.
Manufacturer;  
SUMITOMO BAKELITE CO., LTD.
TOKYO,  JA.
AKIYAMA OPTICAL CO., LTD.
OSAKA-547,  JA.
Manufacturer;  
AKIYAMA OPTICAL CO., LTD.
OSAKA-547,  JA.
AKLA, INC.
LAKE FOREST,  IL,  US.
Initial Importer;  
AKLA AB
DANDERYD,  SW.
AKON PLASTIC ENT., INC.
TWINSBURG,  OH,  US.
Contract Manufacturer;  
AKON PLASTIC ENT., INC.
TWINSBURG,  OH ,  US.
AKRIBEIA, INC.
HUNTSVILLE,  AL,  US.
Manufacturer;  
AKRIBEIA, INC.
HUNTSVILLE,  AL ,  US.
AKRON POLYMER PRODUCTS, INC.
MOGADORE,  OH,  US.
Contract Manufacturer;  
AKRON POLYMER PRODUCTS, INC.
MOGADORE,  OH ,  US.
AKSIOMA, INC.
ST. PETERSBURG,  RS.
Manufacturer;  
AKSIOMA, INC.
ST. PETERSBURG,  RS.
AKSYS, LTD.
LINCOLNSHIRE,  IL,  US.
Manufacturer;   Specification Developer;  
AKSYS, LTD.
LINCOLNSHIRE,  IL ,  US.
AKTINA MEDICAL PHYSICS CORP.
CONGERS,  NY,  US.
Contract Manufacturer;   Manufacturer;  
AKTINA MEDICAL PHYSICS CORP.
CONGERS,  NY ,  US.
A-L COMPRESSED GASES, INC.
SPOKANE,  WA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
A-L COMPRESSED GASES, INC.
SPOKANE,  WA ,  US.
AL MOTTO USA INC.
ROWLAND HEIGHTS,  CA,  US.
Initial Importer;  
AL MOTTO USA INC.
ROWLAND HEIGHTS,  CA ,  US.
AL RICE & ASSOC., INC.
JEFFERSONVILLE,  IN,  US.
Initial Importer;  
AL RICE & ASSOC., INC.
JEFFERSONVILLE,  IN ,  US.
AL.CHI.MI.A. SRL
PONTE S. NICOLO, PADOVA,  IT.
Manufacturer;  
AL.CHI.MI.A. SRL
PONTE S. NICOLO, PADOVA,  IT.
AL.NOOR CORP.
SIALKOT, PUNJAB,  PK.
Manufacturer;  
AL.NOOR CORP.
SIALKOT, PUNJAB,  PK.
ALABAMA TISSUE CENTER, INC.
BIRMINGHAM,  AL,  US.
Manufacturer;  
ALABAMA TISSUE CENTER, INC.
BIRMINGHAM,  AL ,  US.
ALAIN AFFLELOU INTL. S.A.
GENEVA 3,  SZ.
Specification Developer;  
ALAIN AFFLELOU INTL. S.A.
GENEVA 3,  SZ.
ALAIN MIKLI, LTD.
NEW YORK,  NY,  US.
Initial Importer;  
ALAIN MIKLI, LTD.
PARIS,  FR.
ALAMAR INDUSTRIES, INC.
CLEVELAND,  OH,  US.
Initial Importer;  
ALAMAR INDUSTRIES, INC.
CLEVELAND,  OH ,  US.
ALAMO CITY DENTAL SUPPLY CO.
SAN ANTONIO,  TX,  US.
Initial Importer;  
ALAMO CITY DENTAL SUPPLY CO.
SAN ANTONIO,  TX ,  US.
ALAN BILZERIAN
BOSTON,  MA,  US.
Initial Importer;  
ALAN BILZERIAN
BOSTON,  MA ,  US.
ALAN BROTHERS INDUSTRIAL CO., LTD.
YUNG KANG CITY, TAINAN HSIEN,  TW.
Manufacturer;  
ALAN BROTHERS INDUSTRIAL CO., LTD.
YUNG KANG CITY, TAINAN HSIEN,  TW.
ALAN MEDICAL
PALM DESERT,  CA,  US.
Initial Importer;  
ALAN MEDICAL
PALM DESERT,  CA ,  US.
ALAN PENN & ASSOCIATES., INC.
ROCKVILLE,  MD,  US.
Manufacturer;  
ALAN PENN & ASSOCIATES., INC.
ROCKVILLE,  MD ,  US.
ALANCO & RAFAELE TRADING CO.
VANCOUVER,  WA,  US.
Initial Importer;  
ALANCO & RAFAELE TRADING CO.
VANCOUVER,  WA ,  US.
ALARA, INC.
FREMONT,  CA,  US.
Contract Manufacturer;   Manufacturer;  
ALARA, INC.
FREMONT,  CA ,  US.
ALARM ELECTRONICS MFG. CO. INC.
TAYLORSVILLE,  NC,  US.
Manufacturer;  
ALARM ELECTRONICS MFG. CO. INC.
TAYLORSVILLE,  NC ,  US.
ALASKA NATIVE TRIBAL HEALTH CONSORTIUM
ANCHORAGE,  AK,  US.
Manufacturer;   Remanufacturer;  
ALASKA NATIVE TRIBAL HEALTH CONSORTIUM
ANCHORAGE,  AK ,  US.
ALASKA SCIENTIFIC, INC.
ANCHORAGE,  AK,  US.

ALASKA SCIENTIFIC, INC.
ANCHORAGE,  AK ,  US.

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Last Modified: 29 April 2006
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