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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
ITALVIS OCCHIALERIA DI DE SILVESTRO & C. SNC.
VALLESELLA DI CADORE,  IT.
Manufacturer;  
ITALVIS OCCHIALERIA DI DE SILVESTRO & C. SNC.
VALLESELLA DI CADORE,  IT.
ITAMAR MEDICAL
CEASAREA,  IS.
Manufacturer;  
ITAMAR MEDICAL
CEASAREA,  IS.
ITAMAR MEDICAL INC.
NORWOOD,  MA,  US.
Initial Importer;  
ITAMAR MEDICAL
CEASAREA,  IS.
ITA-MED CO.
SOUTH SAN FRANCISCO,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
INTERNATIONAL TRADE ALLIANCE
SOUTH SAN FRANCISCO,  CA ,  US.
ITAPOL INDUSTRIES, LTD.
KOWLOON,  HK.
Manufacturer;  
ITAPOL INDUSTRIES, LTD.
KOWLOON,  HK.
ITC, INC.
MARIETTA,  GA,  US.
Initial Importer;  
ITC, INC.
MARIETTA,  GA ,  US.
ITEC OVERSEAS, LTD.
BARRINGTON,  IL,  US.
Initial Importer;  
ITEC OVERSEAS, LTD.
BARRINGTON,  IL ,  US.
ITEC/EMS LLP
WINNSBORO,  TX,  US.
Manufacturer;  
ITEC/EMS LLP
WINNSBORO,  TX ,  US.
ITEM INDUSTRIES LTD.
SHENZHEN, GUANGDONG,  CH.
Manufacturer;  
ITEM INDUSTRIES LTD.
HONG KONG,  HK.
ITG INC.
OXFORD,  OH,  US.
Initial Importer;  
MANTRA INTL. (HK) LTD.
TSING YI,  HK.
ITG-INTERNATIONAL TECHNOLOGY GROUP
SAN RAFAEL,  CA,  US.
Manufacturer;   Specification Developer;  
ITG-INTERNATIONAL TECHNOLOGY GROUP
SAN RAFAEL,  CA ,  US.
ITG-MEDEV, INC.
SAN FRANCISCO,  CA,  US.
Initial Importer;  
ITG-MEDEV, INC.
SAN FRANCISCO,  CA ,  US.
ITI INTL. TRADING, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
ITI INTL. TRADING, INC.
LOS ANGELES,  CA ,  US.
ITL ASIA PACIFIC SDN BHD
PENG. MAJU, LAHAT, PERAK,  MY.
Manufacturer;  
ITL LIMITED
CANBERRA, ACT,  AS.
ITO CO., LTD.
NERIMA, TOKYO,  JA.
Specification Developer;  
ITO CO., LTD.
NERIMA, TOKYO,  JA.
ITO OPTICAL CO. LTD.
SABE-CITY, FUKUI PREF.,  JA.
Unregistered Foreign Lister;  
ITO OPTICAL CO. LTD.
SABE-CITY, FUKUI PREF.,  JA.
ITOCHU INTERNATIONAL, INC.
NEW YORK,  NY,  US.
Initial Importer;   Specification Developer;  
ITOCHU INTERNATIONAL, INC.
NEW YORK,  NY ,  US.
ITOH OPTICAL INDUSTRIAL CO., LTD.
GAMAGORI-CITY, AICHI PREF,  JA.
Manufacturer;  
ITOH OPTICAL INDUSTRIAL CO., LTD.
GAMAGORI-CITY, AICHI PREF,  JA.
ITS GMBH
KOBLENZ,  GM.
Manufacturer;  
ITS GMBH
KOBLENZ,  GM.
ITT NIGHT VISION
ROANOKE,  VA,  US.
Manufacturer;  
ITT INDUSTRIES
WHITE PLAINS,  NY ,  US.
ITW DELTAR
ELK GROVE VILLAGE,  IL,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ILLINOIS TOOL WORKS, INC.
GLENVIEW,  IL ,  US.
ITW DEVCON
OXFORD,  MI,  US.
Contract Manufacturer;  
ITW DEVCON
DANVERS,  MA ,  US.
ITW DYMON
OLATHE,  KS,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ITW DYMON
OLATHE,  KS ,  US.
ITW MINIGRIP, INC.
ORANGEBURG,  NY,  US.
Manufacturer;  
ITW MINIGRIP, INC.
ORANGEBURG,  NY ,  US.
ITW PASLODE
VERNON HILLS,  IL,  US.
Initial Importer;  
ITW PASLODE
VERNON HILLS,  IL ,  US.
IVAX PHARMACEUTICALS UK, LTD.
RUNCORN, CHESHIRE,  UK.
Manufacturer;  
IVAX PHARMACEUTICALS UK, LTD.
RUNCORN, CHESHIRE,  UK.
IVD BIO-SCIENCE, INC.
EL MONTE,  CA,  US.
Initial Importer;  
IVD BIO-SCIENCE, INC.
EL MONTE,  CA ,  US.
IVD RESEARCH, INC.
CARLSBAD,  CA,  US.
Manufacturer;  
IVD RESEARCH, INC.
CARLSBAD,  CA ,  US.
IVEX PHARMACEUTICALS LIMITED
LARNE,  UK.
Contract Manufacturer;   Contract Sterilizer;  
GAMBRO BCT, INC.
LAKEWOOD,  CO ,  US.
IVF HARTMANN AG
NEUHAUSSEN/RHEINFALL,  SZ.
Manufacturer;  
IVF HARTMANN AG
NEUHAUSEN/RHEINFALL,  SZ.
IVICO USA, INC.
ROSLYN,  NY,  US.
Initial Importer;  
IVICO USA, INC.
ROSLYN,  NY ,  US.
IVKO GMBH
BAAR-WANDERATH,  GM.
Manufacturer;  
IVKO GMBH
BAAR-WANDERATH,  GM.
IVO EYEWEAR, INC.
MIAMI,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
IVO EYEWEAR, INC.
MIAMI,  FL ,  US.
IVO WECKERLE
TUTTLINGEN,  GM.
Manufacturer;  
IVO WECKERLE
TUTTLINGEN,  GM.
IVOCLAR INC.
CABUYAO-MANILA,  RP.
Foreign Exporter;   Manufacturer;  
IVOCLAR VIVADENT AG
SCHAAN,  LS.
IVOCLAR VIVADENT AG
SCHAAN,  LS.
Foreign Exporter;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
IVOCLAR VIVADENT AG
SCHAAN,  LS.
IVOCLAR VIVADENT, GMBH
BURS,  AU.
Manufacturer;  
IVOCLAR VIVADENT AG
SCHAAN,  LS.
IVOCLAR VIVADENT, GMBH
NATURNO (BZ),  IT.
Manufacturer;  
IVOCLAR VIVADENT AG
SCHAAN,  LS.
IVOCLAR VIVADENT, INC.
AMHERST,  NY,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
IVOCLAR VIVADENT AG
SCHAAN,  LS.
IVOCLAR VIVADENT, INC.
BUFFALO,  NY,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
IVOCLAR VIVADENT AG
SCHAAN,  LS.

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Last Modified: 29 April 2006
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