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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
GENTEX CORPORATION
SIMPSON,  PA,  US.
Manufacturer;   Specification Developer;  
GENTEX CORPORATION
SIMPSON,  PA ,  US.
GENTEX OPTICS, INC.
DUDLEY,  MA,  US.
Manufacturer;  
ESSILOR INTERNATIONAL, S.A.
CHARENTON, CEDEX,  FR.
GENTEX OPTICS, INC.
SIMPSON,  PA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ESSILOR OPTICAL, INC.
SIMPSON,  PA ,  US.
GENTHERMICS MEDICAL, INC.
PITTSBURGH,  PA,  US.
Specification Developer;  
GENTHERMICS MEDICAL, INC.
CANONSBURG,  PA ,  US.
GENTING SEMPURNA SDN. BHD.
CHEMOR, PERAK,  MY.
Manufacturer;  
GENTING SEMPURNA SDN. BHD.
CHEMOR, PERAK,  MY.
GENTRA SYSTEMS, INC.
MINNEAPOLIS,  MN,  US.
Manufacturer;   Specification Developer;  
GENTRA SYSTEMS, INC.
MINNEAPOLIS,  MN ,  US.
GENTRONICS
LOS ANGELES,  CA,  US.
Manufacturer;  
GENTRONICS
LOS ANGELES,  CA ,  US.
GENTRY WAY CO., LTD.
TAINAN COUNTRY,  TW.
Manufacturer;  
GENTRY WAY CO., LTD.
KAOHSIUNG,  TW.
GENTRY WAY CO., LTD.
TAIPEI,  TW.
Unregistered Foreign Lister;  
GENTRY WAY CO., LTD.
TAIPEI,  TW.
GENUA 1944, INC.
TORONTO, ONTARIO,  CA.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Specification Developer;  
GENUA 1944, INC.
TORONTO, ONTARIO,  CA.
GENUINE CARE REHAB. SVC., INC.
OKLAHOMA CITY,  OK,  US.
Initial Importer;   Manufacturer;  
GENUINE CARE REHAB. SVC., INC.
OKLAHOMA CITY,  OK ,  US.
GENUINE INTERNATIONAL OPTICAL LTD.
KOWLOON, HONG KONG,  CH.
Manufacturer;  
GENUINE INTERNATIONAL OPTICAL LTD.
KOWLOON, HONG KONG,  CH.
GENUINE INT'L. INVESTMENT LTD.
KOWLOON BAY, KOWLOON BAY,  HK.
Unregistered Foreign Lister;  
GENUINE INT'L. INVESTMENT LTD.
KOWLOON BAY, KOWLOON BAY,  HK.
GENX INTL., INC.
GUILFORD,  CT,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
GENX INTL., INC.
GUILFORD,  CT ,  US.
GENZYME BIOSURGERY
CAMBRIDGE,  MA,  US.
Manufacturer;  
GENZYME CORPORATION
CAMBRIDGE,  MA ,  US.
GENZYME CORP.
CAMBRIDGE,  MA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
GENZYME CORPORATION
CAMBRIDGE,  MA ,  US.
GENZYME CORPORATION
FRAMINGHAM,  MA,  US.
Manufacturer;  
GENZYME CORPORATION
CAMBRIDGE,  MA ,  US.
GENZYME CORPORATION
RIDGEFIELD,  NJ,  US.
Manufacturer;  
GENZYME CORPORATION
CAMBRIDGE,  MA ,  US.
GENZYME DIAGNOSTICS
SAN DIEGO,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
GENZYME CORPORATION
CAMBRIDGE,  MA ,  US.
GENZYME LTD.
ALLINGTON, MAIDSTONE, KENT,  UK.
Manufacturer;  
GENZYME CORPORATION
CAMBRIDGE,  MA ,  US.
GENZYME LTD.
WEST MALLING, KENT,  UK.
Specification Developer;  
GENZYME CORPORATION
CAMBRIDGE,  MA ,  US.
GEO MEDICAL CO., LTD.
DAMYANG-GUN, JEOLANAM-DO,  KS.
Manufacturer;  
GEO MEDICAL CO., LTD.
DAMYANG-GUN, JEOLANAM-DO,  KS.
GEO SANG MEDICAL CO., LTD.
CHUNG JU, CHUNG BUK,  KS.
Manufacturer;  
GEO SANG MEDICAL CO., LTD.
CHUNG JU, CHUNG BUK,  KS.
GEO TRADE LTD
PEACHTREE,  GA,  US.
Initial Importer;  
GEO TRADE LTD
PEACHTREE,  GA ,  US.
GEOMED MEDIZIN-TECHNIK GMBH & CO.
TUTTLINGEN,  GM.
Manufacturer;  
GEOMED MEDIZIN-TECHNIK GMBH & CO.
TUTTLINGEN,  GM.
GEOMETRIC CORP.
TAIPEI CITY,  TW.
Manufacturer;  
GEOMETRIC CORP.
TAIPEI CITY,  TW.
GEOMYUNG CORPORATION
SEOUL,  KS.
Manufacturer;  
GEOMYUNG CORPORATION
SEOUL,  KS.
GEON CORP.
CHANG HWA HSIEN,  TW.
Manufacturer;  
GEON CORP.
CHANG HWA HSIEN,  TW.
GEORG ALBER GMBH & CO. KG
RENQUISHAUSEN,  GM.
Contract Manufacturer;   Manufacturer;  
GEORG ALBER GMBH & CO. KG
RENQUISHAUSEN,  GM.
GEORG LEIBINGER MEDIZINTECHNISCHER APPARATEBAU
MUEHLHEIM,  GM.
Manufacturer;  
GEORG LEIBINGER MEDIZINTECHNISCHER APPARATEBAU
MUEHLHEIM,  GM.
GEORGE BASS
NEW ORLEANS,  LA,  US.
Initial Importer;  
GEORGE BASS
NEW ORLEANS,  LA ,  US.
GEORGE COUREY INC
MONTREAL, QUEBEC,  CA.
Manufacturer;  
GEORGE COUREY INC
MONTREAL, QUEBEC,  CA.
GEORGE FAULHABER
FRITTLINGEN,  GM.
Manufacturer;  
GEORGE FAULHABER
FRITTLINGEN,  GM.
GEORGE GLOVE COMPANY, INC.
MILAND PARK,  NJ,  US.
Initial Importer;   Repackager/Relabeller;  
GEORGE GLOVE COMPANY, INC.
MILAND PARK,  NJ ,  US.
GEORGE J. KAMILAR
BRIGHTWATERS,  NY,  US.
Initial Importer;   Manufacturer;  
GEORGE J. KAMILAR
BRIGHTWATERS,  NY ,  US.
GEORGE KING BIO-MEDICAL, INC.
OVERLAND PARK,  KS,  US.
Manufacturer;  
GEORGE KING BIO-MEDICAL, INC.
OVERLAND PARK,  KS ,  US.
GEORGE MEDICAL LLC.
WHEATON,  IL,  US.
Specification Developer;  
GEORGE MEDICAL LLC.
WHEATON,  IL ,  US.
GEORGE OTIS CO.
VISTA,  CA,  US.
Manufacturer;  
GEORGE OTIS CO.
VISTA,  CA ,  US.
GEORGE TAUB PRODUCTS & FUSION CO., INC.
JERSEY CITY,  NJ,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
GEORGE TAUB PRODUCTS & FUSION CO., INC.
JERSEY CITY,  NJ ,  US.
GEORGE TIEMANN & CO.
HAUPPAUGE,  NY,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
GEORGE TIEMANN & CO.
HAUPPAUGE,  NY ,  US.

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Last Modified: 29 April 2006
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