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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
EKCOMED, LLC
ST. CHARLES,  MO,  US.
Manufacturer;  
EKCOMED, LLC
ST. CHARLES,  MO ,  US.
EKF DIAGNOSTIC GMBH
SAXONY-ANHALT,  GM.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
EKF DIAGNOSTIC GMBH
SAXONY-ANHALT,  GM.
EKLIN MEDICAL SYSTEMS
SUNNYVALE,  CA,  US.
Manufacturer;  
EKLIN MEDICAL SYSTEMS
SUNNYVALE,  CA ,  US.
EKLUND MED PROD, INC.
DES MOINES,  IA,  US.

EKLUND MED PROD, INC.
DES MOINES,  IA ,  US.
EKOM S.R.O.
PIESTANY,  LO.
Manufacturer;  
EKOM S.R.O.
PIESTANY,  LO.
EKOS CORP.
BOTHELL,  WA,  US.
Manufacturer;  
EKOS CORP.
BOTHELL,  WA ,  US.
EKR THERAPEUTICS, INC.
CEDAR KNOLLS,  NJ,  US.
Initial Importer;  
EKR THERAPEUTICS, INC.
CEDAR KNOLLS,  NJ ,  US.
EKS EDUARD KUHNERT GMBH
SOLINGEN,  GM.
Manufacturer;  
EKS EDUARD KUHNERT GMBH
SOLINGEN,  GM.
EL CAJON HEARING AID CENTER
EL CAJON,  CA,  US.
Manufacturer;  
LYNN ROBERT TOWNSEND
EL CAJON,  CA ,  US.
EL MAR, INC.
WEST HARTFORD,  CT,  US.
Manufacturer;  
EL MAR, INC.
WEST HARTFORD,  CT ,  US.
EL PASO LIGHTHOUSE FOR THE BLIND
EL PASO,  TX,  US.
Contract Manufacturer;  
EL PASO LIGHTHOUSE FOR THE BLIND
EL PASO,  TX ,  US.
EL.EN. ELECTRONIC ENGINEERING SPA
CALENZANO,  IT.
Contract Manufacturer;   Manufacturer;  
EL.EN. ELECTRONIC ENGINEERING SPA
CALENZANO,  IT.
ELA MEDICAL S.A.
MONTROUGE,  FR.
Manufacturer;   Specification Developer;  
ELA MEDICAL S.A.
MONTROUGE,  FR.
ELA MEDICAL, INC.
ARVADO,  CO,  US.
Initial Importer;  
ELA MEDICAL, INC.
ARVADA,  CO ,  US.
ELA MEDICAL,INC.
PLYMOUTH,  MN,  US.
Initial Importer;  
ELA MEDICAL, INC.
ARVADA,  CO ,  US.
ELAHI SURGICAL CO.
SIALKOT,  PK.
Unregistered Foreign Lister;  
ELAHI SURGICAL CO.
SIALKOT,  PK.
EL-AID TRADING CO., LTD.
DAE GU,  KS.
Foreign Exporter;  
EL-AID TRADING CO., LTD.
DAE GU,  KS.
ELAN DIAGNOSTICS
BREA,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ELAN PHARMACEUTICALS
SOUTH SAN FRANCISCO,  CA ,  US.
ELAN DIAGNOSTICS, INC.
SMITHFIELD,  RI,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ELAN PHARMACEUTICALS
SOUTH SAN FRANCISCO,  CA ,  US.
ELANTEC MED, INC.
GOLDEN,  CO,  US.
Specification Developer;  
ELANTEC MED, INC.
GOLDEN,  CO ,  US.
ELASTIC CORPORATION OF AMERICA
COLUMBIANA,  AL,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
WORLDTEX, INC.
HICKORY,  NC ,  US.
ELASTIC THERAPY, INC.
ASHEBORO,  NC,  US.
Manufacturer;  
ELASTIC THERAPY, INC.
ASHEBORO,  NC ,  US.
ELASTICA SURQUI, SOCIEDAD ANONIMA
SAN JOSE,  CS.
Manufacturer;  
ELASTICA SURQUI, SOCIEDAD ANONIMA
SAN JOSE,  CS.
ELASTOCRAFT LTD.
MISSISSAUGA, ONTARIO,  CA.
Unregistered Foreign Lister;  
ELASTOCRAFT LTD.
MISSISSAUGA, ONTARIO,  CA.
ELASTOMADE ACCESSORIES SDN BHD
PETALING JAYA,  MY.
Manufacturer;  
ELASTOMADE ACCESSORIES SDN BHD
PETALING JAYA,  MY.
ELASTOTIRE CORP.
MISSISSAUGA, ONTARIO,  CA.
Unregistered Foreign Lister;  
ELASTOTIRE CORP.
MISSISSAUGA, ONTARIO,  CA.
ELBIT, LTD.
HAIFA,  IS.
Manufacturer;  
ELBIT, LTD.
HAIFA,  IS.
ELCA TECHNOLOGIES S.R.L.
IMOLA, BO,  IT.
Foreign Exporter;   Manufacturer;  
CEFLA S.C.R.L.
IMOLA, BO,  IT.
ELCAM MEDICAL A.C.A.L.
D.N. MEROM HAGALIL,  IS.
Contract Manufacturer;   Manufacturer;  
ELCAM MEDICAL A.C.A.L.
D.N. MEROM HAGALIL,  IS.
ELCAM MEDICAL, INC.
HACKENSACK,  NJ,  US.
Initial Importer;  
ELCAM MEDICAL A.C.A.L.
D.N. MEROM HAGALIL,  IS.
ELCAT, GMBH
WOLFRATSHAUSEN,  GM.
Manufacturer;  
ELCAT, GMBH
WOLFRATSHAUSEN,  GM.
ELCOMA METAL FABRICATING
CANTON,  OH,  US.
Initial Importer;  
ELCOMA METAL FABRICATING LTD.
MIDLAND/ONTARIO,  CA.
ELCON MEDICAL INSTRUMENTS GMBH
TUTTLINGEN,  GM.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ELCON MEDICAL INSTRUMENTS GMBH
TUTTLINGEN,  GM.
ELDARI, LTD.
HAIFA,  IS.
Manufacturer;  
ELDARI, LTD.
HAIFA,  IS.
ELDECO MEDICAL PRODUCTS, INC.
AUBURN,  CA,  US.
Manufacturer;  
ELDECO MEDICAL PRODUCTS, INC.
AUBURN,  CA ,  US.
ELDITH - ELECTRO-DIAGNOSTIC & THERAPEUTIC SYSTEMS
ILMENAU, THURINGIA,  GM.
Manufacturer;  
ELDITH - ELECTRO-DIAGNOSTIC & THERAPEUTIC SYSTEMS
ILMENAU, THURINGIA,  GM.
ELDON BIOLOGICALS A/S
GENTOFTE,  DA.
Manufacturer;  
ELDON BIOLOGICALS A/S
GENTOFTE,  DA.
ELECCTRIKA CORPORATION
HIALEAH,  FL,  US.
Initial Importer;  
ELECCTRIKA CORPORATION
HIALEAH,  FL ,  US.
ELECTA LAB S.R.L.
FORLI,  IT.
Manufacturer;   Specification Developer;  
ELECTA LAB S.R.L.
FORLI,  IT.
ELEC-TECH INTERNATIONAL CO., LTD.
NANPING ZHU HAI, GUANG DONG,  CH.
Specification Developer;  
ELEC-TECH INTERNATIONAL CO., LTD.
NANPING ZHU HAI, GUANG DONG,  CH.

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Last Modified: 29 April 2006
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