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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
ADVANTAGE DENTAL LABORATORIES, PVT LTD.
HYDERABAD, ANDHRA PRADESH,  IN.
Manufacturer;  
ADVANTAGE DENTAL LABORATORIES, PVT LTD.
HYDERABAD, ANDHRA PRADESH,  IN.
ADVANTAGE DENTAL PRODUCTS, INC.
CLARKSTON,  MI,  US.
Specification Developer;  
ADVANTAGE DENTAL PRODUCTS, INC.
CLARKSTON,  MI ,  US.
ADVANTAGE DIAGNOSTICS CORP
TUCSON,  AZ,  US.
Initial Importer;  
ADVANTAGE DIAGNOSTICS CORP
TUCSON,  AZ ,  US.
ADVANTAGE DIAGNOSTICS CORPORATION
SUNNYVALE,  CA,  US.
Manufacturer;   Repackager/Relabeller;  
ADVANTAGE DIAGNOSTICS CORP
SUNNYVALE,  CA ,  US.
ADVANTAGE HEALTHCARE CORP.
DULUTH,  GA,  US.
Initial Importer;  
ADVANTAGE HEALTHCARE CORP.
DULUTH,  GA ,  US.
ADVANTAGE MARKETING
ROCKVILLE,  MD,  US.
Initial Importer;  
ADVANTAGE MARKETING
ROCKVILLE,  MD ,  US.
ADVANTAGE MEDICAL ELECTRONICS, INC.
CORAL SPRINGS,  FL,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ADVANTAGE MEDICAL ELECTRONICS, INC.
CORAL SPRINGS,  FL ,  US.
ADVANTAGE MEDICAL EQUIPMENT & SUPPLY, INC.
CARMEL,  IN,  US.
Initial Importer;  
ADVANTAGE MEDICAL EQUIPMENT & SUPPLY, INC.
CARMEL,  IN ,  US.
ADVANTAGE MEDICAL SYSTEMS, INC.
AURORA,  CO,  US.
Specification Developer;  
ADVANTAGE MEDICAL SYSTEMS, INC.
AURORA,  CO ,  US.
ADVANTAGE MEDICAL SYSTEMS, INC.
PORTLAND,  OR,  US.

ADVANTAGE MEDICAL SYSTEMS, INC.
PORTLAND,  OR ,  US.
ADVANTEC VASCULAR CORP.
SUNNYVALE,  CA,  US.
Contract Manufacturer;   Manufacturer;  
AVANTEC VASCULAR CORP.
SUNNYVALE,  CA ,  US.
ADVANTECH, INC.
STERLING,  VA,  US.
Initial Importer;   Repackager/Relabeller;  
ADVANTECH, INC.
STERLING,  VA ,  US.
ADVANTEQ DEVELOPMENT CORP.
THOUSAND OAKS,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ADVANTEQ DEVELOPMENT CORP.
THOUSAND OAKS,  CA ,  US.
ADVANTIS MEDICAL, INC.
GREENWOOD,  IN,  US.
Contract Manufacturer;   Manufacturer;  
ADVANTIS MEDICAL, INC.
GREENWOOD,  IN ,  US.
ADVENT HOME HEALTH CARE
LOS GATOS,  CA,  US.
Initial Importer;  
BAY AREA OXYGEN SUPPLY, INC.
LOS GATOS,  CA ,  US.
ADVENTURE MEDICAL KITS
OAKLAND,  CA,  US.
Manufacturer;  
ADVENTURE MEDICAL KITS
OAKLAND,  CA ,  US.
ADVENTURES IN COLOR TECHNOLOGY, LTD.
GOLDEN,  CO,  US.
Contract Manufacturer;  
ADVENTURES IN COLOR TECHNOLOGY, LTD.
GOLDEN,  CO ,  US.
ADVERTISING SPECIALTY SERVICES OF SAVANNAH, INC.
SAVANNAH,  GA,  US.
Initial Importer;  
ADVERTISING SPECIALTY SERVICES OF SAVANNAH, INC.
SAVANNAH,  GA ,  US.
ADVOCATE 4 DENTAL TECHNOLOGY, INC.
HOPKINTON,  MA,  US.
Initial Importer;  
ADVOCATE 4 DENTAL TECHNOLOGY, INC.
HOPKINTON,  MA ,  US.
ADWIN KOREA CORP.
KANNAM-GU SEOUL,  KS.
Manufacturer;  
ADWIN KOREA CORP.
KANNAM-GU SEOUL,  KS.
ADWIN KOREA CORP.
SEOUL,  KS.
Manufacturer;  
ADWIN KOREA CORP.
SEOUL,  KS.
AE DENTAL LABORATORY
TEL AVIV,  IS.
Manufacturer;  
AE DENTAL LABORATORY
TEL AVIV,  IS.
AE DENTALNET LIMITED
N.T., HONG KONG,  CH.
Manufacturer;  
AE DENTALNET INC.
N.T., HONG KONG,  CH.
AEA TECHNOLOGY, QSA GMBH
BRAUNSCHWEIG,  GM.
Unregistered Foreign Lister;  
AEA TECHNOLOGY, QSA GMBH
BRAUNSCHWEIG,  GM.
AEA TECHNOLOGY/QSA, INC.
BURLINGTON,  MA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
AEAT PLC
DIDCOT, OXEN,  UK.
AEARO AO SAFETY
PLYMOUTH,  IN,  US.
Initial Importer;   Manufacturer;  
AEARO COMPANY
INDIANAPOLIS,  IN ,  US.
AEARO CANADA LTD.
MISSISSAUGA, ONT.,  CA.
Manufacturer;  
AEARO COMPANY
INDIANAPOLIS,  IN ,  US.
AEARO CO.
INDIANAPOLIS,  IN,  US.
Initial Importer;  
AEARO COMPANY
INDIANAPOLIS,  IN ,  US.
AEARO COMPANY
CHICKASHA,  OK,  US.
Initial Importer;   Manufacturer;  
AEARO COMPANY
INDIANAPOLIS,  IN ,  US.
AEARO COMPANY
SOUTHBRIDGE,  MA,  US.
Manufacturer;  
AEARO COMPANY
INDIANAPOLIS,  IN ,  US.
AEGIS, INC.
MARYVILLE,  TN,  US.
Initial Importer;  
AEGIS, INC.
MARYVILLE,  TN ,  US.
AEI TECHNOLOGIES INC.
PITTSBURG,  PA,  US.
Manufacturer;  
AEI TECHNOLOGIES INC.
NAPERVILLE,  IL ,  US.
AEIOMED, INC.
MINNEAPOLIS,  MN,  US.
Manufacturer;   Specification Developer;  
AEIOMED, INC.
MINNEAPOLIS,  MN ,  US.
AEKYUNG INDUSTRIAL CO., LTD.
CHEONGYANG-GU, CHUNGNAM,  KS.
Unregistered Foreign Lister;  
AEKYUNG INDUSTRIAL CO., LTD.
CHEONGYANG-GU, CHUNGNAM,  KS.
AEMCO Z.E. (PVT), LTD.
SIALKOT-3,  PK.
Contract Manufacturer;   Manufacturer;  
AEMCO Z.E. (PVT), LTD.
SIALKOT-3,  PK.
AEMED, INC.
WEST PALM BEACH,  FL,  US.
Initial Importer;   Specification Developer;  
AEMED, INC.
WEST PALM BEACH,  FL ,  US.
AEOLUS INTERNATIONAL CORPORATION
MARION,  MA,  US.
Specification Developer;  
AEOLUS INTERNATIONAL CORPORATION
MARION,  MA ,  US.
AERFISH, INC.
FUKUI-CITY, FUKUI-PREF.,  JA.
Manufacturer;  
AERFISH, INC.
FUKUI-CITY, FUKUI-PREF.,  JA.
AERIAL VISION SUNWEAR
INDIANAPOLIS,  IN,  US.
Initial Importer;  
AERIAL VISION SUNWEAR
INDIANAPOLIS,  IN ,  US.
AERIFORM CORP.
HOUSTON,  TX,  US.
Manufacturer;  
AERIFORM CORP.
HOUSTON,  TX ,  US.

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Last Modified: 29 April 2006
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