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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
ENTHERMICS MEDICAL SYSTEMS, INC.
MENOMONEE FALLS,  WI,  US.
Manufacturer;  
ENTHERMICS MEDICAL SYSTEMS, INC.
MENOMONEE FALLS,  WI ,  US.
ENTIFIC MEDICAL SYSTEMS AB
GOTEBORG,  SW.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
COCHLEAR LTD.
LANE COVE NSW,  AS.
ENTITY INTERNATIONAL, INC.
ANAHEIM,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
ENTITY INTERNATIONAL, INC.
ANAHEIM,  CA ,  US.
ENTKIT LTD
TAIPEI,  TW.
Specification Developer;  
ENTKIT LTD
TAIPEI,  TW.
ENTLAB OY
HAMEENLINNA,  FI.
Manufacturer;  
ENTLAB OY
HAMEENLINNA,  FI.
ENTRACARE, LLC
LENEXA,  KS,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ENTRACARE, LLC
LENEXA,  KS ,  US.
ENURESIS ASSOCIATES LLC
ASHTON,  MD,  US.
Initial Importer;  
ENURESIS ASSOCIATES LLC
ASHTON,  MD ,  US.
ENURESIS SOLUTIONS, LLC
SAVANNAH,  GA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ENURESIS SOLUTIONS, LLC
SAVANNAH,  GA ,  US.
ENVIROCLEAN INC.
GARLAND,  TX,  US.
Repackager/Relabeller;  
ENVIROCLEAN MANAGEMENT SERVICES, INC.
DALLAS,  TX ,  US.
ENVIROCLEAN INC.
HOUSTON,  TX,  US.
Repackager/Relabeller;  
ENVIROCLEAN MANAGEMENT SERVICES, INC.
DALLAS,  TX ,  US.
ENVIROMETRIC LABORATORIES, INC.
GERMANTOWN,  MD,  US.
Initial Importer;  
WIENER LABORATORIES S.A.I.C.
ROSARIO,  AR.
ENVIRONMENTAL LIGHTING CONCEPTS, INC.
TAMPA,  FL,  US.
Initial Importer;  
ENVIRONMENTAL LIGHTING CONCEPTS, INC.
TAMPA,  FL ,  US.
ENVIRONMENTAL TECTONICS CORP.
SOUTHAMPTON,  PA,  US.
Manufacturer;  
ENVIRONMENTAL TECTONICS CORP.
SOUTHAMPTON,  PA ,  US.
ENVIRONMENTAL TECTONICS CORP.
SOUTHAMPTON,  PA,  US.
Manufacturer;  
ENVIRONMENTAL TECTONICS CORP.
SOUTHAMPTON,  PA ,  US.
ENVIROPAK LLC
FLORENCE,  AL,  US.
Manufacturer;  
ENVIROPAK LLC
PEACHTREE CITY,  GA ,  US.
ENVIROSOLVE INC.
TULSA,  OK,  US.
Repackager/Relabeller;  
ENVIROCLEAN MANAGEMENT SERVICES, INC.
DALLAS,  TX ,  US.
ENVISION DENTAL SOLUTIONS
IDAHO FALLS,  ID,  US.
Manufacturer;  
ENVISION DENTAL SOLUTIONS
IDAHO FALLS,  ID ,  US.
ENVISION ENTERPRISES, INC.
BRYN MAWR,  PA,  US.
Initial Importer;   Specification Developer;  
ENVISION ENTERPRISES, INC.
BRYN MAWR,  PA ,  US.
ENVISION MEDICAL TECHNOLOGY, LLC
OKLAHOMA CITY,  OK,  US.
Repackager/Relabeller;  
ENVISION MEDICAL TECHNOLOGY, LLC
OKLAHOMA CITY,  OK ,  US.
ENVISIONEERING MEDICAL TECHNOLOGIES
SAINT LOUIS,  MO,  US.
Manufacturer;   Specification Developer;  
ENVISIONEERING, LLC.
ST. LOUIS,  MO ,  US.
ENVITEC-WISMAR GMBH
WISMAR, MECKLEN.-VORPOMM,  GM.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
FIRST TECHNOLOGY PLC
EGHAM, SURREY,  UK.
ENYO LIMITED
LONDON,  UK.
Foreign Exporter;  
ENYO LIMITED
LONDON,  UK.
ENZTEC LIMITED
CHRISTCHURCH,  NZ.
Foreign Exporter;   Manufacturer;  
ENZTEC LIMITED
CHRISTCHURCH,  NZ.
ENZYME SOLUTIONS, INC.
FORT WAYNE, IN,  IN,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ENZYME SOLUTIONS, INC.
FORT WAYNE, IN,  IN ,  US.
ENZYMIC TECHNOLOGIES SDN BHD
MELAKA,  MY.
Manufacturer;  
ENZYMIC TECHNOLOGIES SDN BHD
MELAKA,  MY.
E-ON ELECTRONICS
GUANG DONG,  CH.
Manufacturer;  
K-JUMP HEALTH CO., LTD.
TAIPEI HSIEN,  TW.
EON TECHNOLOGY CO., LTD.
SHU-LIN, TAIPEI HSIEN,  TW.
Unregistered Foreign Lister;  
EON TECHNOLOGY CO., LTD.
SHU-LIN, TAIPEI HSIEN,  TW.
EOS-WERKE, GUNTHER GMBH
DRIEDORF,  GM.
Manufacturer;  
EOS-WERKE, GUNTHER GMBH
DRIEDORF,  GM.
EP EUROPE AB
STROMSTAD,  SW.
Specification Developer;  
EP EUROPE AB
STROMSTAD,  SW.
EP MEDSYSTEMS
WEST BERLIN,  NJ,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
EP MEDSYSTEMS
WEST BERLIN,  NJ ,  US.
EP USA LLC
MIAMI,  FL,  US.
Initial Importer;  
EP USA LLC
MIAMI,  FL ,  US.
EPC ENT.
LAKE FOREST,  IL,  US.
Initial Importer;  
EPC ENT.
LAKE FOREST,  IL ,  US.
EPE CORP.
MANCHESTER,  NH,  US.
Contract Manufacturer;  
EPE CORP.
MANCHESTER,  NH ,  US.
EPG
BROOKLYN,  NY,  US.
Initial Importer;  
EPG
BROOKLYN,  NY ,  US.
EPI PRINTERS, INC.
INDIANAPOLIS,  IN,  US.
Contract Manufacturer;  
EPI PRINTERS, INC.
BATTLE CREEK,  MI ,  US.
EPIC TECHNOLOGIES
NORWALK,  OH,  US.
Contract Manufacturer;  
ELECTRONIC PRODUCT INTEGRATION
SOUTHFIELD,  MI ,  US.
EPIC TECHNOLOGIES, LLC
JOHNSON CITY,  TN,  US.
Contract Manufacturer;  
EAR TECHNOLOGY CORP.
JOHNSON CITY,  TN ,  US.
EPICOR MEDICAL, INC.
SUNNYVALE,  CA,  US.
Manufacturer;  
EPICOR MEDICAL, INC.
SUNNYVALE,  CA ,  US.
EPIKEIA, INC.
SAN ANTONIO,  TX,  US.
Initial Importer;   Manufacturer;  
EPIKEIA, INC.
SAN ANTONIO,  TX ,  US.
EPILADY 2000, L.L.C.
D.N. UPPER GALILEE,  IS.
Manufacturer;  
EPILADY 2000, L.L.C.
D.N. UPPER GALILEE,  IS.

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Last Modified: 29 April 2006
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