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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
ENGELHARD CORP.
EAST WINDSOR,  CT,  US.
Contract Manufacturer;  
ENGELHARD CORP.
ISELIN,  NJ ,  US.
ENGELKEN INTERNATIONAL, LLC
RIDGEWOOD,  NJ,  US.
Initial Importer;  
ENGELKEN INTERNATIONAL, LLC
RIDGEWOOD,  NJ ,  US.
ENGENDERHEALTH
NEW YORK,  NY,  US.
Initial Importer;  
ENGENDERHEALTH
NEW YORK,  NY ,  US.
ENGINEERED MEDICAL SYSTEMS
INDIANAPOLIS,  IN,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;  
ENGINEERED MEDICAL SYSTEMS
INDIANAPOLIS,  IN ,  US.
ENGINEERED OUTSOURCE SOLUTIONS
SUNNYVALE,  CA,  US.
Contract Manufacturer;  
ENGINEERED OUTSOURCE SOLUTIONS
SUNNYVALE,  CA ,  US.
ENGINEERED PLASTIC COMPONENTS, INC.
MATTAWAN,  MI,  US.
Contract Manufacturer;  
ALCOA FUJIKURA LTD.-EPC
MATTAWAN,  MI ,  US.
ENGINEERED RECOVERY SYSTEMS, INC.
NEWTON,  KS,  US.
Manufacturer;  
ENGINEERED RECOVERY SYSTEMS, INC.
SHAWNEE MISSION,  KS ,  US.
ENGINEERING & RESEARCH ASSOCIATES, INC.
TUCSON,  AZ,  US.
Contract Manufacturer;   Manufacturer;  
ENGINEERING & RESEARCH ASSOCIATES, INC.
TUCSON,  AZ ,  US.
ENGINEERING MARKETING ASSOC.
NEWNAN,  GA,  US.
Manufacturer;  
ENGINEERING MARKETING ASSOC.
NEWNAN,  GA ,  US.
ENGINEERING SERVICES KENNETH C. SALTRICK INC.
TWINSBURG,  OH,  US.
Contract Manufacturer;   Remanufacturer;  
ENGINEERING SERVICES KENNETH C. SALTRICK INC.
TWINSBURG,  OH ,  US.
ENGINEERS & DOCTORS A/S
KVISTGAARD,  DA.
Manufacturer;  
ENGINEERS & DOCTORS A/S
KVISTGAARD,  DA.
ENGLE DENTAL SYSTEMS, INC.
FOREST GROVE,  OR,  US.
Manufacturer;  
ENGLE DENTAL SYSTEMS, INC.
FOREST GROVE,  OR ,  US.
ENGLER ENGINEERING CORP.
HIALEAH,  FL,  US.
Manufacturer;  
ENGLER ENGINEERING CORP.
HIALEAH,  FL ,  US.
ENHANCED LISTENING TECHNOLOGIES, CORP.
WEST PALM BEACH,  FL,  US.
Initial Importer;  
ENHANCED LISTENING TECHNOLOGIES, CORP.
WEST PALM BEACH,  FL ,  US.
ENHANCED MOBILITY SOLUTIONS
INVER GROVE HEIGHTS,  MN,  US.
Manufacturer;  
ENHANCED MOBILITY SOLUTIONS
INVER GROVE HEIGHTS,  MN ,  US.
ENHANCED MOBILITY TECHNOLOGIES
GOLDEN VALLEY,  MN,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ENHANCED MOBILITY TECHNOLOGIES
GOLDEN VALLEY,  MN ,  US.
ENKAY (INDIA) RUBBER CO. PVT. LTD.
DELHI,  IN.
Manufacturer;  
ENKAY (INDIA) RUBBER CO. PVT. LTD.
DELHI,  IN.
ENMEX DE MEXICO, SA DE CV
TECATE,  MX.
Foreign Exporter;   Contract Manufacturer;  
ENMEX DE MEXICO, SA DE CV
TECATE,  MX.
ENNCO DISPLAY SYSTEMS
REDMOND,  WA,  US.
Initial Importer;  
ENNCO DISPLAY SYSTEMS
REDMOND,  WA ,  US.
ENNEKING MEDICAL INC.
KANSAS CITY,  MO,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
ENNEKING MEDICAL INC.
KANSAS CITY,  MO ,  US.
ENOCHS MFG., INC.
INDIANAPOLIS,  IN,  US.
Manufacturer;   Specification Developer;  
ENOCHS MFG., INC.
INDIANAPOLIS,  IN ,  US.
ENOVA MEDICAL TECHNOLOGIES
ST. PAUL,  MN,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Contract Sterilizer;   Repackager/Relabeller;  
ENOVA MEDICAL TECHNOLOGIES
ST. PAUL,  MN ,  US.
ENPATH MEDICAL INC.
BLOOMINGTON,  MN,  US.
Contract Manufacturer;   Manufacturer;  
ENPATH MEDICAL INC.
MINNEAPOLIS,  MN ,  US.
ENPATH MEDICAL, INC.
MINNEAPOLIS,  MN,  US.
Contract Manufacturer;   Manufacturer;  
ENPATH MEDICAL INC.
MINNEAPOLIS,  MN ,  US.
ENRAF-NONIUS B.V.
3047 AT ROTTERDAM,  NL.
Specification Developer;  
NEW COMPANY INVESTMENTS B.V.
DELFT,  NL.
ENSAMBLES DE CALIDAD MEXICO, SA DE CV
TIJUANA, BC,  MX.
Manufacturer;  
ENSAMBLES DE CALIDAD MEXICO, SA DE CV
TIJUANA, BC,  MX.
ENSAMBLES DE PRECISION S.A. DE C.V
TIJUANA, BAJA CALIFORNIA,  MX.
Contract Manufacturer;  
TELEDYNE ELECTRONIC TECHNOLOGIES
LEWISBURG,  TN ,  US.
ENSAMBLES DE PRECISION S.A. DE C.V
TIJUANA,  MX.
Contract Manufacturer;  
TELEDYNE INSTRUMENTS - ANALYTICAL INSTRUMENTS
CITY OF INDUSTRY,  CA ,  US.
ENSAMBLES NYPRO S.A. DE C.V.
OTAY, TIJUANA B.C. C.P.,  MX.
Unregistered Foreign Lister;  
ENSAMBLES NYPRO S.A. DE C.V.
OTAY, TIJUANA B.C. C.P.,  MX.
ENSATEC, S.A. DE C.V.
TIJUANA, B.C.,  MX.
Manufacturer;  
MEDSEP CORP., A SUBSIDIARY OF PALL CORP.
COVINA,  CA ,  US.
ENSI-MED MANUFACTURING PTY LTD.
O'MALLEY ACT,  AS.
Manufacturer;   Specification Developer;  
ENSI-MED MANUFACTURING PTY LTD.
SEAFORD VIC,  AS.
ENSURE MEDICAL, INC.
SUNNYVALE,  CA,  US.
Manufacturer;  
ENSURE MEDICAL, INC.
SUNNYVALE,  CA ,  US.
ENTA/LACTONA B.V.
BERGEN OP ZOOM,HOLLAND,  NL.
Unregistered Foreign Lister;  
ENTA/LACTONA B.V.
BERGEN OP ZOOM,HOLLAND,  NL.
ENTACO LTD.
STUDLEY, WARWICKSHIRE,  UK.
Contract Manufacturer;   Manufacturer;  
ENTACO LTD.
STUDLEY, WARWICKSHIRE,  UK.
ENTER MEDICAL CORPORATION
GUI SHAN XIANG,TAO YUAN HSIEN,  TW.
Manufacturer;  
ENTER MEDICAL CORPORATION
GUI SHAN XIANG,TAO YUAN HSIEN,  TW.
ENTER NEWEST IMPORT & EXPORT
SOUTH EL MONTE,  CA,  US.
Initial Importer;  
ENTER NEWEST IMPORT & EXPORT
SOUTH EL MONTE,  CA ,  US.
ENTERIX INC.
EDISON,  NJ,  US.
Manufacturer;  
ENTERIX INC.
EDISON,  NJ ,  US.
ENTERMED INTERNATIONAL B.V.
HE LINSCHOTEN,  NL.
Manufacturer;  
ENTERMED INTERNATIONAL B.V.
HE LINSCHOTEN,  NL.
ENTERNET MEDICAL, INC.
LAS VEGAS,  NV,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
ENTERNET MEDICAL, INC.
LAS VEGAS,  NV ,  US.
ENTERPREX INTERNATIONAL CORP.
ARCADIA,  CA,  US.
Initial Importer;  
ENTERPREX INTERNATIONAL CORP.
ARCADIA,  CA ,  US.

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Last Modified: 29 April 2006
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