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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
ASIAN GENERAL FOODS
SAN MARCOS,  CA,  US.
Initial Importer;  
ASIAN GENERAL FOODS
SAN MARCOS,  CA ,  US.
ASIAN WORLD TRADING CO., INC.
KILDEER,  IL,  US.
Initial Importer;  
ASIAN WORLD TRADING CO., INC.
KILDEER,  IL ,  US.
ASIANETWORKS, LLC.
PACIFIC GROVE,  CA,  US.
Initial Importer;  
ASIANETWORKS, LLC.
PACIFIC GROVE,  CA ,  US.
ASIA-PLUS CO., LTD.
CHANG HUA CITY,  TW.
Manufacturer;  
ASIA-PLUS CO., LTD.
CHANG HUA CITY,  TW.
ASIATIC LENS SUPPLY
SINGAPORE,  SN.
Contract Manufacturer;  
ASIATIC LENS SUPPLY
SINGAPORE,  SN.
ASICO LLC
WESTMONT,  IL,  US.
Initial Importer;  
ASICO LLC
WESTMONT,  IL ,  US.
ASIM INSTRUMENTS
SIALKOT,  PK.
Manufacturer;  
ASIM INSTRUMENTS
SIALKOT,  PK.
ASIMAX, INC.
KAUSALA,  FI.
Manufacturer;  
ASIMAX, INC.
KAUSALA,  FI.
ASK ABOUT...LLC
CUPERTINO,  CA,  US.
Initial Importer;  
ASK ABOUT...LLC
CUPERTINO,  CA ,  US.
ASKIT KFT
BUDAPEST,  HU.
Manufacturer;  
IMRE JAKOBICZ
BUDAPEST,  HU.
ASKLE
NIMES,  FR.
Unregistered Foreign Lister;  
ASKLE
NIMES,  FR.
ASL INDUSTRY CO., LTD.
DALIAN,  CH.
Unregistered Foreign Lister;  
ASL INDUSTRY CO., LTD.
DALIAN,  CH.
ASMA RUBBER PRODUCTS PVT. LTD.
COCHIN, KERALA,  IN.
Manufacturer;  
ASMA RUBBER PRODUCTS PVT. LTD.
COCHIN, KERALA,  IN.
ASO CORP.
SARASOTA,  FL,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
ASO CORP.
SARASOTA,  FL ,  US.
ASO PHILIPPINES, INC.
LAPU-LAPU CITY, CEBU,  RP.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ASO CORP.
SARASOTA,  FL ,  US.
ASP PLASTICS PTY LTD.
ST-MARYS NSW,  AS.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ASP PLASTICS PTY LTD.
ST-MARYS NSW,  AS.
ASPECT MEDICAL SYSTEMS, INC.
NEWTON,  MA,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
ASPECT MEDICAL SYSTEMS, INC.
NEWTON,  MA ,  US.
ASPEN DENTAL MANAGEMENT, INC.
N. SYRACUSE,  NY,  US.
Initial Importer;  
ASPEN DENTAL MANAGEMENT, INC.
N. SYRACUSE,  NY ,  US.
ASPEN ENGINEERED PRODUCTS, LLC.
VISTA,  CA,  US.
Contract Manufacturer;  
ASPEN ENGINEERED PRODUCTS, LLC.
VISTA,  CA ,  US.
ASPEN MEDICAL PRODUCTS
IRVINE,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
ASPEN MEDICAL PRODUCTS
IRVINE,  CA ,  US.
ASPEN MEDICAL, INC.
ENGLEWOOD,  CO,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ASPEN MEDICAL, INC.
ENGLEWOOD,  CO ,  US.
ASPEN MEDICAL, INC.
LITTLE ROCK,  AR,  US.
Initial Importer;  
ASPEN MEDICAL, INC.
LITTLE ROCK,  AR ,  US.
ASPEN PROMOTION
ONTARIO,  CA,  US.
Initial Importer;  
ASPEN MARKETING
ONTARIO,  CA ,  US.
ASPEN SEATING, LLC
SHERIDAN,  CO,  US.
Manufacturer;  
ASPEN SEATING, LLC
SHERIDAN,  CO ,  US.
ASPEN SURGICAL PRODUCTS, INC.
CALEDONIA,  MI,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
ASPEN SURGICAL PRODUCTS, INC.
CALEDONIA,  MI ,  US.
ASPEX EYEWEAR, INC.
MIRAMAR,  FL,  US.
Initial Importer;  
ASPEX EYEWEAR, INC.
MIRAMAR,  FL ,  US.
A-SPINE ASIA, CO., LTD
NEIHU CHIU, TAIPEI,  TW.
Manufacturer;  
A-SPINE ASIA, CO., LTD
NEIHU CHIU, TAIPEI,  TW.
ASPINE USA, INC.
SAN FRANCISCO,  CA,  US.
Specification Developer;   Repackager/Relabeller;  
ASPINE USA, INC.
SAN FRANCISCO,  CA ,  US.
ASPIRE BIOTECH, INC.
COLORADO SPRINGS,  CO,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;  
ASPIRE BIOTECH, INC.
COLORADO SPRINGS,  CO ,  US.
ASPYRA, INC.
CALABASAS,  CA,  US.
Manufacturer;  
ASPYRA, INC.
CALABASAS,  CA ,  US.
ASPYRA, INC.
JACKSONVILLE,  FL,  US.
Manufacturer;  
ASPYRA, INC.
CALABASAS,  CA ,  US.
ASSAMED GMBH
BEXBACH,  GM.
Manufacturer;  
ASSAMED GMBH
BEXBACH,  GM.
ASSEMBLED PRODUCTS, INC.
ROGERSVILLE,  AL,  US.
Contract Manufacturer;  
ASSEMBLED PRODUCTS, INC.
ROGERSVILLE,  AL ,  US.
ASSEMBLERS, INC.
CHICAGO,  IL,  US.
Repackager/Relabeller;  
ASSEMBLERS, INC.
CHICAGO,  IL ,  US.
ASSEMBLY REQUIRED DIST., INC.
COMMACK,  NY,  US.
Initial Importer;  
ASSEMBLY REQUIRED DIST., INC.
COMMACK,  NY ,  US.
ASSISTANCE PRODUCTS LP
GARLAND,  TX,  US.
Initial Importer;   Manufacturer;  
ASSISTANCE PRODUCTS LP
GARLAND,  TX ,  US.
ASSISTANCE SRL
BUENOS AIRES,  AR.
Manufacturer;  
ASSISTANCE SRL
BUENOS AIRES,  AR.
ASSISTECH CORP.
NEWTOWN SQUARE,  PA,  US.
Specification Developer;  
ASSISTECH CORP.
NEWTOWN SQUARE,  PA ,  US.
ASSISTIVE DEVICES, INC.
AUSTIN,  TX,  US.
Initial Importer;  
ASSISTIVE DEVICES, INC.
AUSTIN,  TX ,  US.
ASSOC. MERCHANDISING CORP.
NEW YORK,  NY,  US.
Initial Importer;  
ASSOC. MERCHANDISING CORP.
NEW YORK,  NY ,  US.

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Last Modified: 29 April 2006
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