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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
GE MEDICOR
BUDAPEST,  HU.
Manufacturer;  
GE MEDICOR
BUDAPEST,  HU.
GE OEC MEDICAL SYSTEMS
LAWRENCE,  MA,  US.
Specification Developer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE OEC MEDICAL SYSTEMS
SALT LAKE CITY,  UT,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE OEC MEDICAL SYSTEMS GMBH
WENDELSTEIN,  GM.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE OPTICAL CO., LTD.
TAIPEI,  TW.
Manufacturer;  
GE OPTICAL CO., LTD.
TAIPEI,  TW.
GE PARALLEL DESIGN, INC.
PHOENIX,  AZ,  US.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE ULTRASOUND KOREA CO., LTD.
SUNGNAM-SHI, KYUNGGI-DO,  KS.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE VINGMED ULTRASOUND
HORTEN,  NO.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE YOKOGAWA MEDICAL SYSTEMS
HINO-SHI, TOKYO,  JA.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE.O SRL
SANTORSO (VICENZA),  IT.
Unregistered Foreign Lister;  
GE.O SRL
SANTORSO (VICENZA),  IT.
GEARING (HUIZHOU) IND. DEVELOPMENT CO., LTD.
GUANG DONG,  CH.
Contract Manufacturer;  
GEARING INTERNATIONAL LTD
WAN, KOWLOON,  HK.
GEARING INTERNATIONAL LTD
KOWLOON,  HK.
Contract Manufacturer;   Manufacturer;  
GEARING INTERNATIONAL LTD
KOWLOON,  HK.
GEBAUER CO.
CLEVELAND,  OH,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
GEBAUER CO.
CLEVELAND,  OH ,  US.
GEBAUER MEDIZINTECHNIK GMBH
BADEN-WURTTEMBERG,  GM.
Manufacturer;  
GEBAUER MEDIZINTECHNIK GMBH
BADEN-WURTTEMBERG,  GM.
GEBHARD ACKERMANN CHIRURGISCHE INSTRUMENTE
RIETHEIM-WEILHEIM,  GM.
Contract Manufacturer;   Manufacturer;  
GEBHARD ACKERMANN CHIRURGISCHE INSTRUMENTE
RIETHEIM-WEILHEIM,  GM.
GEBR. BRASSELER GMBH & CO. KG
LEMGO,  GM.
Manufacturer;  
GEBR. BRASSELER GMBH & CO. KG
LEMGO,  GM.
GEBR. ECHTERHOLTER ECHTENIA-SONNENBRILLE
4937 LAGE,  GM.
Manufacturer;  
ECHTERHOLTER GMBH ECHTENIA SONNENBRILLEN
4937 LAGE,  GM.
GEBR. KUEMMERLE GMBH
RHEINFELDEN-MINSELN, BADEN-W.,  GM.
Manufacturer;  
GEBR. KUEMMERLE GMBH
RHEINFELDEN-MINSELN, BADEN-W.,  GM.
GEBRUDER HASLAUER GMBH
MITTERFELDEN,  GM.
Unregistered Foreign Lister;  
GEBRUDER HASLAUER GMBH
MITTERFELDEN,  GM.
GEBRUDER MARTIN GMBH & CO. KG
D-78532 TUTTLINGEN,  GM.
Repackager/Relabeller;  
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
MUHLHEIM,  GM.
GEBRUDER WOLL GMBH-BRILLENFABRIK
BAD KREUZNACH,RHEINLAND-PFALZ,  GM.
Manufacturer;  
GERTI HILL UND WOLL ERBEN GEMEINSCHAFT
BAD KREUZNACH, RHEINLAND-PFALZ,  GM.
GEBRUEDER ZEPF
DUERBHEIM,  GM.
Manufacturer;  
GEBRUEDER ZEPF
DUERBHEIM,  GM.
GEE LUCK INDUSTRIES, LTD.
TSUEN WAN N.T.,  HK.
Unregistered Foreign Lister;  
GEE LUCK INDUSTRIES, LTD.
TSUEN WAN N.T.,  HK.
GEE YEI EYEWEAR CO.,LTD.
TAINAN HSIEN,  TW.
Unregistered Foreign Lister;  
GEE YEI EYEWEAR CO.,LTD.
TAINAN HSIEN,  TW.
GEEJEES
MOORPARK,  CA,  US.
Initial Importer;  
GEEJEES
MOORPARK,  CA ,  US.
GEEN HEALTHCARE, INC.
SCARBOROUGH, ONTARIO,  CA.
Manufacturer;  
GEEN HEALTHCARE, INC.
SCARBOROUGH, ONTARIO,  CA.
GEISTER MEDIZINTECHNIK GMBH
TUTTLINGEN,  GM.
Manufacturer;  
GEISTER MEDIZINTECHNIK GMBH
TUTTLINGEN,  GM.
GEISTLICH-PHARMA
WOLHUSEN,  SZ.
Manufacturer;  
GEISTLICH-PHARMA
WOLHUSEN,  SZ.
GEKA BRUSH GMBH
BECHHOFEN,  GM.
Unregistered Foreign Lister;  
GEKA BRUSH GMBH
BECHHOFEN,  GM.
GEL CONCEPTS LLC.
WHIPPANY,  NJ,  US.
Manufacturer;  
GEL CONCEPTS LLC.
WHIPPANY,  NJ ,  US.
GELFLEX LABORATORIES
PERTH, WESTERN, WA,  AS.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
GELFLEX LABORATORIES
OSBORNE PARK, WA,  AS.
GELFLEX USA, INC.
DANBURY,  CT,  US.
Initial Importer;  
GELFLEX LABORATORIES
OSBORNE PARK, WA,  AS.
GEL-LITE, L.L.C.
KNOXVILLE,  TN,  US.
Manufacturer;  
GEL-LITE, L.L.C.
KNOXVILLE,  TN ,  US.
GELMAN SCIENCES, INC.
ANN ARBOR,  MI,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;  
GELMAN SCIENCES, INC.
ANN ARBOR,  MI ,  US.
GELMED INTERNATIONAL
KAMENNE ZEHROVICE,  EZ.
Manufacturer;  
GELMED INTERNATIONAL
KAMANNE ZEHROVICE,  EZ.
GEM HOUR INDUSTRIAL CO., LTD.
TAIPEI,  TW.
Repackager/Relabeller;  
GEM HOUR INDUSTRIAL CO., LTD.
TAIPEI,  TW.
GEM LUNETTERIE
BELLIGNAT,  FR.
Manufacturer;  
GEM LUNETTERIE
BELLIGNAT,  FR.
GEM OFFICE PRODUCTS, INC.
KAOHSIUNG,  TW.
Manufacturer;  
GEM OFFICE PRODUCTS, INC.
KAOHSIUNG,  TW.
GEM STORES, INC.
JAMAICA,  NY,  US.
Initial Importer;  
GEM STORES, INC.
JAMAICA,  NY ,  US.
GEM VISION CO., LTD.
TAIPEI,  TW.
Manufacturer;  
GEM VISION CO., LTD.
TAIPEI,  TW.

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Last Modified: 29 April 2006
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