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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
GAMA, A.S.
CESKE BUDEJOVICE,  EZ.
Manufacturer;  
GAMA, A.S.
CESKE BUDEJOVICE,  EZ.
GAMBRO BCT, INC.
LAKEWOOD,  CO,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
GAMBRO BCT, INC.
LAKEWOOD,  CO ,  US.
GAMBRO DASCO S.P.A.
MEDOLLA,  IT.
Manufacturer;   Specification Developer;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO DASCO S.P.A.
MEDOLLA (MO),  IT.
Manufacturer;   Specification Developer;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO DIAYLZATOREN GMBH
HECHINGEN,  GM.
Manufacturer;   Specification Developer;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO ENGSTROM AB
BROMMA,  SW.
Unregistered Foreign Lister;  
GAMBRO ENGSTROM AB
BROMMA,  SW.
GAMBRO INDUSTRIES
MEYZIEU CEDEX,  FR.
Manufacturer;   Specification Developer;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO KATHETERTECHNIK HECHINGEN
HECHINGEN,  GM.
Manufacturer;   Specification Developer;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO LUNDIA AB
LUND,  SW.
Manufacturer;   Specification Developer;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO LUNDIA AB
LUND,  SW.
Manufacturer;   Specification Developer;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO RENAL PRODUCTS
SONDALO (SO),  IT.
Manufacturer;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO RENAL PRODUCTS
DAYTONA BEACH,  FL,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO RENAL PRODUCTS S.A. DE C.V.
TIJUANA, BCN,  MX.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO RENAL PRODUCTS, INC.
LAKEWOOD,  CO,  US.
Initial Importer;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO RENAL PRODUCTS, INC.
LAKEWOOD,  CO,  US.
Initial Importer;  
GAMBRO AB
STOCKHOLM,  SW.
GAMBRO SYSTEMS, INC.
LAKEWOOD,  CO,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
GAMBRO AB
STOCKHOLM,  SW.
GAMMA BIOLOGICALS, INC.
HOUSTON,  TX,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
IMMUCOR, INC.
NORCROSS,  GA ,  US.
GAMMA DIRECT MEDICAL
CARY,  NC,  US.
Manufacturer;  
GAMMA HEALTH, INC.
LAKE FOREST,  IL ,  US.
GAMMA MEDICA-IDEAS
NORTHRIDGE,  CA,  US.
Manufacturer;  
GAMMA MEDICA-IDEAS
NORTHRIDGE,  CA ,  US.
GAMMA MEDIZINISCH WISSENSCHAFTLICHE FORTBILDUNGSGE
KLOSTERNEUBURG,  AU.
Manufacturer;  
GAMMA MEDIZINISCH WISSENSCHAFTLICHE FORTBILDUNGSGE
KLOSTERNEUBURG,  AU.
GAMMA OPTICAL
CINCINNATI,  OH,  US.
Initial Importer;  
GAMMA OPTICAL
CINCINNATI,  OH ,  US.
GAMMASONICS
FIVE DOCK NSW 2046,  AS.
Manufacturer;  
GAMMASONICS
FIVE DOCK NSW 2046,  AS.
GAMMASTER PROVENCE S.A.
MARSEILLE,  FR.
Contract Sterilizer;  
GAMMASTER PROVENCE S.A.
MARSEILLE,  FR.
GAMMEX, INC.
BENICIA,  CA,  US.
Manufacturer;  
GAMMEX, INC.
MIDDLETON,  WI ,  US.
GAMMEX, INC.
MIDDLETON,  WI,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
GAMMEX, INC.
MIDDLETON,  WI ,  US.
GAMMEX, INC.
MILWAUKEE,  WI,  US.
Manufacturer;  
GAMMEX, INC.
MIDDLETON,  WI ,  US.
GANGQUAN PRECISION (SHENZHEN) CO. LTD.
BAOAN, SHENZHEN,  CH.
Unregistered Foreign Lister;  
GANGQUAN PRECISION (SHENZHEN) CO. LTD.
BAOAN, SHENZHEN,  CH.
GANTEC CORP.
HOFFMAN ESTATES,  IL,  US.
Initial Importer;  
GANTEC CORP.
HOFFMAN ESTATES,  IL ,  US.
GANZ INDUSTRIES SDN. BHD.
KUALA LUMPUR,  MY.
Manufacturer;  
GANZ INDUSTRIES SDN. BHD.
KUALA LUMPUR,  MY.
GANZONI & CIE AG
ST GALLEN,  SZ.
Manufacturer;  
GANZONI & CIE AG
ST GALLEN,  SZ.
GAO YAO CITY LI SHENG PLASTIC CO., LTD.
GAO YAO CITY GUAGDONG,  CH.
Manufacturer;  
GAO YAO CITY LI SHENG PLASTIC CO., LTD.
GAO YAO CITY GUAGDONG,  CH.
GAOMING KING DA TOURISM NECESSITIES CO., LTD.
GUANGDONG,  CH.
Unregistered Foreign Lister;  
GAOMING KING DA TOURISM NECESSITIES CO., LTD.
GUANGDONG,  CH.
GAPADENT CO., LTD.
TIANJIN,  CH.
Manufacturer;  
GAPADENT CO., LTD.
TIANJIN,  CH.
GAPER PRODUCTS, LTD.
MISSISSAUGA, ONTARIO,  CA.
Manufacturer;  
GAPER PRODUCTS, LTD.
MISSISSAUGA, ONTARIO,  CA.
GAPO INDUSTRIAL CORP.
TAINAN HSIEN,  TW.
Manufacturer;  
GAPO INDUSTRIAL CORP.
TAINAN HSIEN,  TW.
GARA PLASTIC PRODUCTS FACTORY LTD
SAN PO KONG, KOWLOON,  HK.
Manufacturer;  
GARA PLASTIC PRODUCTS FACTORY LTD
SAN PO KONG, KOWLOON,  HK.
GARANA INDUSTRIES (PVT), LTD.
SIALKOT,  PK.
Manufacturer;  
GARANA INDUSTRIES
SIALKOT,  PK.
GARAVENTA (CANADA) LTD.
SURREY, B.C.,  CA.
Repackager/Relabeller;  
GARAVENTA (CANADA) LTD.
SURREY, B.C.,  CA.
GARDASUN INTL., B.V.
DIDAM/ZEVENAAR,  NL.
Manufacturer;  
GARDASUN INTL., B.V.
DIDAM/ZEVENAAR,  NL.
GARDEN CITY MEDICAL, INC.
CALHOUN,  GA,  US.
Initial Importer;  
GARDEN CITY MEDICAL, INC.
MARLBORO,  NJ ,  US.

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Last Modified: 29 April 2006
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