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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
ENCORE PRODUCTS, INC.
HAUPPAUGE,  NY,  US.
Initial Importer;  
ENCORE PRODUCTS, INC.
HAUPPAUGE,  NY ,  US.
ENCORE TECHNOLOGY, INC.
SANTA CLARA,  CA,  US.
Initial Importer;  
FRED KINDER
SANTA CLARA,  CA ,  US.
ENDEAVOR MEDICAL, INC.
LARGO,  FL,  US.
Initial Importer;  
ENDEAVOR MEDICAL, INC.
LARGO,  FL ,  US.
ENDIUS, INC.
PLAINVILLE,  MA,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
ENDIUS, INC.
PLAINVILLE,  MA ,  US.
ENDLESS FOREST, INC.
HOLLYWOOD,  FL,  US.
Initial Importer;  
ENDLESS FOREST, INC.
HOLLYWOOD,  FL ,  US.
ENDLESS POOLS, INC.
ASTON,  PA,  US.
Manufacturer;  
ENDLESS POOLS, INC.
ASTON,  PA ,  US.
ENDO IMAGE CORP.
GETTYSBURG,  PA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ENDO IMAGE CORP.
GETTYSBURG,  PA ,  US.
ENDO OPTIKS, INC.
LITTLE SILVER,  NJ,  US.
Manufacturer;  
ENDO OPTIKS, INC.
LITTLE SILVER,  NJ ,  US.
ENDO PLANT MUELLER GMBH
KLEINWALLSTADT,  GM.
Manufacturer;  
ENDO PLANT MUELLER GMBH
KLEINWALLSTADT,  GM.
ENDO SURGICAL CONCEPTS, INC.
GREENWICH,  CT,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ENDO SURGICAL CONCEPTS, INC.
GREENWICH,  CT ,  US.
ENDO TECHNIC
SAN DIEGO,  CA,  US.
Initial Importer;  
ENDO TECHNIC
SAN DIEGO,  CA ,  US.
ENDO TEX INTERVENTIONAL SYSTEMS, INC.
CUPERTINO,  CA,  US.
Manufacturer;  
ENDO TEX INTERVENTIONAL SYSTEMS, INC.
CUPERTINO,  CA ,  US.
ENDOCARE, INC.
IRVINE,  CA,  US.
Manufacturer;  
ENDOCARE, INC.
IRVINE,  CA ,  US.
ENDOCO, INC.
MEMPHIS,  TN,  US.
Initial Importer;  
ENDOCO, INC.
MEMPHIS,  TN ,  US.
ENDOCRAFT LLC.
PROVIDENCE,  RI,  US.
Manufacturer;  
ENDOCRAFT LLC.
BOSTON,  MA ,  US.
ENDODENT, INC.
DUARTE,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
COLTENE/WHALEDENT AG
ALTSTAETTEN,  SZ.
ENDO-INSTRUMENTS MEDIZINTECHNIK GMBH
WURMLINGEN,  GM.
Manufacturer;  
ENDO-INSTRUMENTS MEDIZINTECHNIK GMBH
WURMLINGEN,  GM.
ENDOLITE NORTH AMERICA, LTD.
CENTERVILLE,  OH,  US.
Initial Importer;   Manufacturer;  
ENDOLITE NORTH AMERICA, LTD.
CENTERVILLE,  OH ,  US.
ENDOLOGIX, INC.
IRVINE,  CA,  US.
Manufacturer;  
ENDOLOGIX, INC.
IRVINE,  CA ,  US.
ENDO-MED THECHNICS USA
HILLSIDE,  NJ,  US.
Initial Importer;  
ENDO-MED THECHNICS USA
HILLSIDE,  NJ ,  US.
ENDOPLUS, INC.
BUFFALO GROVE,  IL,  US.
Contract Manufacturer;   Manufacturer;  
ENDOPLUS, INC.
BUFFALO GROVE,  IL ,  US.
ENDOPORT INC.
ALTAMONTE SPRINGS,  FL,  US.
Manufacturer;  
ENDOPORT INC.
ALTAMONTE SPRINGS,  FL ,  US.
ENDORPHIN, INC.
PINELLAS PARK,  FL,  US.
Manufacturer;  
ENDORPHIN, INC.
PINELLAS PARK,  FL ,  US.
ENDOSCOPIC SURGICAL SPEC.
SIMI VALLEY,  CA,  US.
Initial Importer;  
ENDOSCOPIC SURGICAL SPEC.
SIMI VALLEY,  CA ,  US.
ENDOTEC, INC.
ORLANDO,  FL,  US.
Manufacturer;  
ENDOTEC, INC.
SOUTH ORANGE,  NJ ,  US.
ENDO-THERAPEUTICS, INC.
SAFETY HARBOR,  FL,  US.
Manufacturer;  
ENDO-THERAPEUTICS, INC.
SAFETY HARBOR,  FL ,  US.
ENDOVASCULAR INSTRUMENTS, INC.
VANCOUVER,  WA,  US.
Manufacturer;  
ENDOVASCULAR INSTRUMENTS, INC.
VANCOUVER,  WA ,  US.
ENDURA INDUSTRIES
SIALKOT,  PK.
Manufacturer;  
ENDURA INDUSTRIES
SIALKOT,  PK.
ENDURA TAPE
CLAREVILLE, N.S.W.,  AS.
Unregistered Foreign Lister;  
ENDURA TAPE
CLAREVILLE, N.S.W.,  AS.
ENDURA-TAPE PTY LIMITED
SYDNEY,  AS.
Foreign Exporter;  
MCCONELL INSTITUTE
SAMMAMISH,  WA ,  US.
ENDURE MEDICAL, INC.
CUMMING,  GA,  US.
Initial Importer;   Manufacturer;  
ENDURE MEDICAL, INC.
CUMMING,  GA ,  US.
ENDURO MEDICAL TECHNOLOGY, INC.
EAST HARTFORD,  CT,  US.
Manufacturer;  
ENDURO MEDICAL TECHNOLOGY, INC.
EAST HARTFORD,  CT ,  US.
ENEM ENTERPRISES INC.
BROOKLYN,  NY,  US.
Initial Importer;  
ENEM ENTERPRISES INC.
BROOKLYN,  NY ,  US.
ENERCON TECHNOLOGIES
GRAY,  ME,  US.
Contract Manufacturer;  
ENERCON TECHNOLOGIES
GRAY,  ME ,  US.
ENERGY BEAM SCIENCES, INC.
EAST GRANBY,  CT,  US.
Manufacturer;   Specification Developer;  
ENERGY BEAM SCIENCES, INC.
EAST GRANBY,  CT ,  US.
ENERGY MEDICINE CENTER
NEWPORT BEACH,  CA,  US.
Manufacturer;  
ENERGY MEDICINE CENTER
NEWPORT BEACH,  CA ,  US.
ENERTRON ENGINEERING CO.
ALHAMBA,  CA,  US.
Manufacturer;  
ENERTRON ENGINEERING CO.
ALHAMBA,  CA ,  US.
E-NET EYEWEAR., LTD.
DAEGU,  KS.
Manufacturer;  
JUNG KEUN LEE
TAEGU,  KS.
ENEWLIFE, INC.
CITY OF INDUSTRY,  CA,  US.
Initial Importer;  
ENEWLIFE, INC.
CITY OF INDUSTRY,  CA ,  US.
ENG3 CORPORATION
SEATTLE,  WA,  US.
Initial Importer;  
ENG3 CORPORATION
SEATTLE,  WA ,  US.

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Last Modified: 29 April 2006
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