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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
GC CORP.
TOKYO,  JA.
Manufacturer;  
GC CORP.
TOKYO,  JA.
GC DENTAL PRODUCTS CORP.
KASUGAI-CITY, AICHI,  JA.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
GC CORP.
TOKYO,  JA.
GC EUROPE N.V.
LEUVEN,  BE.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
GC CORP.
TOKYO,  JA.
GCE S.R.O
CHOTEBOR,  EZ.
Manufacturer;  
GCE GAS CONTROL EQUIPMENT AB
MALMOE,  SW.
GDM ELECTRONIC ASSEMBLY
MILPITAS,  CA,  US.
Contract Manufacturer;  
GDM ELECTRONIC ASSEMBLY
MILPITAS,  CA ,  US.
GDP RESEARCH PTY LTD
LOCKLEYS, SOUTH AUSTRALIA,  AS.
Manufacturer;  
GDP RESEARCH PTY LTD
LOCKLEYS, SOUTH AUSTRALIA,  AS.
GDS TECHNOLOGY
ELKHART,  IN,  US.
Contract Manufacturer;   Manufacturer;  
STANBIO LABORATORY
BOERNE,  TX ,  US.
GE BE PRIVATE LTD.
WHITEFIELD, BANGALORE,  IN.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
BEIJING PR,  CH.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE HEALTHCARE FINLAND OY
HELSINKI,  FI.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI ,  US.
GE HEALTHCARE FINLAND OY
TUUSULA,  FI.
Contract Manufacturer;   Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE HEALTHCARE INFORMATION TECHNOLOGIES
MARKHAM, ONTARIO,  CA.
Manufacturer;   Specification Developer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE HEALTHCARE INFORMATION TECHNOLOGIES
ZEIST,  NL.
Specification Developer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE HEALTHCARE INFORMATION TECHNOLOGIES
BARRINGTON,  IL,  US.
Specification Developer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE HEALTHCARE INFORMATION TECHNOLOGIES
MOUNT PROSPECT,  IL,  US.
Manufacturer;   Specification Developer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE HEALTHCARE INFORMATION TECHNOLOGIES
SIOUX FALLS,  SD,  US.
Specification Developer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE HEALTHCARE LTD.
AMERSHAM, BUCKINGHAMSHIRE,  UK.
Manufacturer;  
GE HEALTHCARE LTD.
AMERSHAM, BUCKINGHAMSHIRE,  UK.
GE IMATRON
SOUTH SAN FRANCISCO,  CA,  US.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE INFRASTRUCTURE SENSING, INC.
BILLERICA,  MA,  US.
Manufacturer;  
GE INFRASTRUCTURE SENSING, INC.
BILLERICA,  MA ,  US.
GE INFRASTRUCTURE, WATER & PROCESS TECHNOLOGIES
MINNETONKA,  MN,  US.
Manufacturer;  
GE INFRASTRUCTURE, WATER & PROCESS TECHNOLOGIES
MINNETONKA,  MN ,  US.
GE INSPECTION TECHNOLOGIES, LP
LEWISTOWN,  PA,  US.
Contract Manufacturer;  
GE INSPECTION TECHNOLOGIES, LP
LEWISTOWN,  PA ,  US.
GE MAGNETS
FLORENCE,  SC,  US.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC
WEST MILWAUKEE,  WI,  US.
Manufacturer;   Specification Developer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MEDICAL INC.
CAPE CORAL,  FL,  US.
Initial Importer;  
GE MEDICAL INC.
CAPE CORAL,  FL ,  US.
GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.
WHITEFIELD, BANGALORE,  IN.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MEDICAL SYSTEMS CHINA CO., LTD.
WUXI, JIANGSU PROVINCE,  CH.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MEDICAL SYSTEMS F.I. HAIFA
TIRAT HACARMEL,  IS.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
JUAREZ, CHIH,  MX.
Manufacturer;   Repackager/Relabeller;  
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI ,  US.
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
EL PASO,  TX,  US.
Initial Importer;   Reprocessor of single-use devices;   Manufacturer;  
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI ,  US.
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MENOMONEE FALLS,  WI,  US.
Specification Developer;  
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI ,  US.
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI ,  US.
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
TAMPA,  FL,  US.
Specification Developer;  
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI ,  US.
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
FREIBURG,  GM.
Manufacturer;   Specification Developer;  
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI ,  US.
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
TIRAT HACARMEL,  IS.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MEDICAL SYSTEMS KRETZTECHNIK GMBH & CO. OHG
ZIPF,  AU.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MEDICAL SYSTEMS MEXICO, S.A.DE C.V.
APODACA, NUEVO LEON,  MX.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MEDICAL SYSTEMS SCS
BUC CEDEX,  FR.
Manufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
MADISON,  WI,  US.
Initial Importer;   Manufacturer;   Remanufacturer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MEDICAL SYSTEMS, LLC
WAUKESHA,  WI,  US.
Manufacturer;   Specification Developer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.
GE MEDICAL SYSTEMS, LLC
WAUKESHA,  WI,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
GENERAL ELECTRIC CO.
FAIRFIELD,  CT ,  US.

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Last Modified: 29 April 2006
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