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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
GEMA, INC.
CHICAGO,  IL,  US.
Manufacturer;  
GEMA, INC.
CHICAGO,  IL ,  US.
GEMART OPTICS CORP.
SANTA MONICA,  CA,  US.
Initial Importer;  
GEMART OPTICS CORP.
SANTA MONICA,  CA ,  US.
GEMINI INTL. PVT., LTD.
MUMBAI, MAHARASTRA,  IN.
Unregistered Foreign Lister;  
GEMINI INTL. PVT., LTD.
MUMBAI, MAHARASTRA,  IN.
GEMMY INDUSTRIAL CORP.
TAIPEI,  TW.
Manufacturer;  
GEMMY INDUSTRIAL CORP.
TAIPEI,  TW.
GEMORE TECHNOLOGY CO., LTD.
TAN SHUI, TAIPEI HSIEN,  TW.
Manufacturer;  
GEMORE TECHNOLOGY CO., LTD.
TAN SHUI, TAIPEI HSIEN,  TW.
GEMSTAR, INC.
MONSEY,  NY,  US.
Initial Importer;  
GEMSTAR, INC.
MONSEY,  NY ,  US.
GEMTECH PRODUCTS, INC.
HOUSTON,  TX,  US.
Manufacturer;  
GEMTECH MEDICAL
HOUSTON,  TX ,  US.
GEN KOR COMPANY
SAN DIEGO,  CA,  US.
Initial Importer;  
GEN KOR COMPANY
SAN DIEGO,  CA ,  US.
GEN TRAK, INC.
LIBERTY,  NC,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
GEN TRAK, INC.
LIBERTY,  NC ,  US.
GENACO BIOMEDICAL PRODUCTS
HUNTSVILLE,  AL,  US.
Manufacturer;  
GENACO BIOMEDICAL PRODUCTS
HUNTSVILLE,  AL ,  US.
GENADYNE BIOTECHNOLOGIES, INC.
GREAT NECK,  NY,  US.
Initial Importer;   Manufacturer;  
GENADYNE BIOTECHNOLOGIES, INC.
GREAT NECK,  NY ,  US.
GENAIREX, INC.
CLEARWATER,  FL,  US.
Initial Importer;  
GENAIREX, INC.
CLEARWATER,  FL ,  US.
GENAMERICA UNITED CORP.
OXNARD,  CA,  US.
Initial Importer;  
GENAMERICA UNITED CORP.
OXNARD,  CA ,  US.
GENBIO
SAN DIEGO,  CA,  US.
Manufacturer;  
GENBIO
SAN DIEGO,  CA ,  US.
GENCARE SYSTEMS INC.
KINGS PARK,  NY,  US.
Initial Importer;  
GENCARE SYSTEMS INC.
KINGS PARK,  NY ,  US.
GENCHEM, INC.
BREA,  CA,  US.
Contract Manufacturer;   Manufacturer;  
GENCHEM, INC.
BREA,  CA ,  US.
GENCIBROSSE
LOCTUDY,  FR.
Specification Developer;   Repackager/Relabeller;  
GENCIBROSSE
LOCTUDY,  FR.
GENDEX DENTAL SYSTEMS
CUSANO MILANINO, MILANO,  IT.
Manufacturer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
GENDEX DENTAL SYSTEMS
DES PLAINES,  IL,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
GENDRON, INC.
ARCHBOLD,  OH,  US.
Manufacturer;  
GENDRON, INC.
ARCHBOLD,  OH ,  US.
GENEMASTER LIFESCIENCES CO., LTD.
CHUNGHO CITY, TAIPEI,  TW.
Manufacturer;  
GENEMASTER LIFESCIENCES CO., LTD.
CHUNGHO CITY, TAIPEI,  TW.
GENEMAX MEDICAL PRODUCTS INDUSTRY CORP.
TAICHUNG,  TW.
Unregistered Foreign Lister;  
GENEMAX MEDICAL PRODUCTS INDUSTRY CORP.
TAICHUNG,  TW.
GENEMAX MEDICAL PRODUCTS INDUSTRY CORP.
TAICHUNG,  TW.
Unregistered Foreign Lister;  
GENEMAX MEDICAL PRODUCTS INDUSTRY CORP.
TAICHUNG,  TW.
GENEMAX MEDICAL PRODUCTS INDUSTRY CORP.
WU-JIH, TAICHUNG,  TW.
Manufacturer;  
GENEMAX MEDICAL PRODUCTS INDUSTRY CORP.
WU-JIH, TAICHUNG,  TW.
GENEMED BIOTECHNOLOGIES, INC.
SOUTH SAN FRANCISCO,  CA,  US.
Contract Manufacturer;  
GENEMED BIOTECHNOLOGIES, INC.
SOUTH SAN FRANCISCO,  CA ,  US.
GENEMED, INC.
KREUZLINGEN,  SZ.
Specification Developer;  
GENEMED, INC.
KREUZLINGEN,  SZ.
GENENTECH, INC.
SOUTH SAN FRANCISCO,  CA,  US.
Initial Importer;  
GENENTECH, INC.
SOUTH SAN FRANCISCO,  CA ,  US.
GENEOHM SCIENCES CANADA, INC.
SAINTE-FOY,  CA.
Manufacturer;  
GENEOHM SCIENCES, INC.
SAN DIEGO,  CA ,  US.
GENEOHM SCIENCES, INC.
SAN DIEGO,  CA,  US.
Initial Importer;   Specification Developer;  
GENEOHM SCIENCES, INC.
SAN DIEGO,  CA ,  US.
GENERAL AIR SERVICE AND SUPPLY
COMMERCE CITY,  CO,  US.
Manufacturer;  
GENERAL AIR SERVICE AND SUPPLY
DENVER,  CO ,  US.
GENERAL APPLIANCES & ELECTRONICS DISTRIBUTORS, INC
MIAMI,  FL,  US.
Initial Importer;  
GENERAL APPLIANCES & ELECTRONICS DISTRIBUTORS, INC
MIAMI,  FL ,  US.
GENERAL ASSEMBLY & MFG. CORP.
CARY,  IL,  US.
Contract Manufacturer;  
GENERAL ASSEMBLY & MFG. CORP.
CARY,  IL ,  US.
GENERAL ASSEMBLY CORP.
WEST JEFFERSON,  NC,  US.
Contract Manufacturer;  
GENERAL ASSEMBLY CORP.
WEST JEFFERSON,  NC ,  US.
GENERAL AUTOMATION, INC.
SKOKIE,  IL,  US.
Contract Manufacturer;  
MAX J. STARR
SKOKIE,  IL ,  US.
GENERAL BANDAGES, INC.
MORTON GROVE,  IL,  US.
Manufacturer;  
GENERAL BANDAGES, INC.
MORTON GROVE,  IL ,  US.
GENERAL CARDIAC TECHNOLOGY, INC.
SANTA CRUZ,  CA,  US.
Manufacturer;  
GENERAL CARDIAC TECHNOLOGY, INC.
SANTA CRUZ,  CA ,  US.
GENERAL COMPOSITES, INC.
WESTPORT,  NY,  US.
Contract Manufacturer;  
GENERAL COMPOSITES, INC.
WESTPORT,  NY ,  US.
GENERAL DENTAL PRODUCTS, INC.
ELY,  NV,  US.
Manufacturer;  
GENERAL DENTAL PRODUCTS, INC.
ELY,  NV ,  US.
GENERAL DEVICES
RIDGEFIELD,  NJ,  US.
Contract Manufacturer;   Manufacturer;  
GENERAL DEVICES
RIDGEFIELD,  NJ ,  US.
GENERAL ECON. & TECH. DEV. CORP.
WENZHOU, ZHEJIANG PROVINCE,  CH.
Manufacturer;  
WENZHOU ECONOMIC & OCEANGOING GLASSES CO., LTD.
WUTIAN TOWN, OUHAI,  CH.

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Last Modified: 29 April 2006
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