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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
ELEVEN ELEVEN CORP.
GUAYNABO,  PR,  US.
Initial Importer;  
ELEVEN ELEVEN CORP.
GUAYNABO,  PR ,  US.
EL-FAX COMPANY, INC.
ARDMORE,  PA,  US.
Manufacturer;  
EL-FAX COMPANY, INC.
ARDMORE,  PA ,  US.
ELGAR DENTAL PRODUCTS, INC.
LAS VEGAS,  NV,  US.
Manufacturer;  
ELGAR DENTAL PRODUCTS, INC.
LAS VEGAS,  NV ,  US.
ELI LILLY AND CO.
INDIANAPOLIS,  IN,  US.
Initial Importer;   Manufacturer;  
ELI LILLY AND CO.
INDIANAPOLIS,  IN ,  US.
ELIAV-MEDICAL IMAGING SYSTEMS, LTD.
NAHARIYA,  IS.
Manufacturer;  
ELIAV-MEDICAL IMAGING SYSTEMS, LTD.
NAHARIYA,  IS.
E-LIFE INTERNATIONAL LTD.
ALTRINCHAM, CHESHIRE,  UK.
Manufacturer;  
E-LIFE INTERNATIONAL LTD.
ALTRINCHAM, CHESHIRE,  UK.
ELIKA INDUSTRIES CORP.
JACKSONVILLE,  FL,  US.
Initial Importer;  
ELIKA INDUSTRIES CORP.
JACKSONVILLE,  FL ,  US.
ELIM PREFERRED SERVICES, INC.
PLYMOUTH,  MN,  US.
Initial Importer;  
ELIM PREFERRED SERVICES, INC.
PLYMOUTH,  MN ,  US.
ELIMAY
PHOENIX,  AZ,  US.
Initial Importer;   Specification Developer;  
ELIMAY
PHOENIX,  AZ ,  US.
ELISA/ACT BIOTECHNOLOGIES
STERLING,  VA,  US.
Initial Importer;  
ELISA/ACT BIOTECHNOLOGIES
STERLING,  VA ,  US.
ELITE DENTAL CERAMICS
HIGHLAND PARK,  IL,  US.
Initial Importer;  
ELITE DENTAL CERAMICS
HIGHLAND PARK,  IL ,  US.
ELITE DENTAL TECHNOLOGY
FORTLEE,  NJ,  US.
Initial Importer;  
ELITE DENTAL TECHNOLOGY
FORTLEE,  NJ ,  US.
ELITE DISTRIBUTING CO., INC,
TORRANCE,  CA,  US.
Initial Importer;  
ELITE DISTRIBUTING CO., INC,
TORRANCE,  CA ,  US.
ELITE ELECTRONICS INSTRUMENTS LTD.
KWUN TONG,  HK.
Manufacturer;  
ELITE ELECTRONICS INSTRUMENTS LTD.
KWUN TONG,  HK.
ELITE EYEWEAR CO.
DAEGU,  KS.
Manufacturer;  
ELITE EYEWEAR CO.
DAEGU,  KS.
ELITE GROUP SRL
CAERANO SAN MARCO - TV,  IT.
Manufacturer;  
ELITE GROUP SRL
CAERANO SAN MARCO - TV,  IT.
ELITE GROUP SRL
MONTEBELLUNA -TV,  IT.
Unregistered Foreign Lister;  
ELITE GROUP SRL
MONTEBELLUNA -TV,  IT.
ELITE INTERNATIONAL, INC.
SONGJIANG DISTRICT, SHANGHAI,  CH.
Manufacturer;  
ELITE INTERNATIONAL, INC.
SONGJIANG DISTRICT, SHANGHAI,  CH.
ELITE LABORATORIES
PHOENIX,  AZ,  US.
Manufacturer;  
EATON VETERINARY LABORATORY, INC.
PHOENIX,  AZ ,  US.
ELITE MEDICAL DISTRIBUTORS
ST. PETERSBURG,  FL,  US.
Initial Importer;  
ELITE MEDICAL DISTRIBUTORS
ST. PETERSBURG,  FL ,  US.
ELITE MEDICAL EQUIPMENT
COLORADO SPRINGS,  CO,  US.
Manufacturer;  
ELITE MEDICAL EQUIPMENT
COLORADO SPRINGS,  CO ,  US.
ELITE MEDICAL PRODUCTS INC.
SAYREVILLE,  NJ,  US.
Initial Importer;  
ELITE MEDICAL PRODUCTS INC.
SAYREVILLE,  NJ ,  US.
ELITE MEDICAL PRODUCTS, INC.
PALMDALE,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ELITE MEDICAL PRODUCTS, INC.
PALMDALE,  CA ,  US.
ELITE MEDICAL TECHNOLOGIES, INC.
EAST BRUNSWICK,  NJ,  US.
Initial Importer;  
ELITE MEDICAL TECHNOLOGIES, INC.
EAST BRUNSWICK,  NJ ,  US.
ELITE MFG.
HAGERSVILLE, ONTARIO,  CA.
Manufacturer;  
ELITE MFG.
HAGERSVILLE, ONTARIO,  CA.
ELITE MFG., INC.
ST. LOUIS,  MO,  US.
Manufacturer;  
ELITE MFG., INC.
ST. LOUIS,  MO ,  US.
ELITE OPTICAL CO., INC.
LYNBROOK,  NY,  US.
Initial Importer;  
ELITE OPTICAL CO., INC.
LYNBROOK,  NY ,  US.
ELITE OPTICAL, INC.
SUNNY ISLES,  FL,  US.
Initial Importer;  
ELITE OPTICAL, INC.
SUNNY ISLES,  FL ,  US.
ELITE ORTHOPAEDICS, INC.
SOUTH EL MONTE,  CA,  US.
Initial Importer;   Manufacturer;  
ELITE ORTHOPAEDICS, INC.
SOUTH EL MONTE,  CA ,  US.
ELITE WHOLESALE MEDICAL SUPPLIES, INC.
DALLAS,  TX,  US.
Initial Importer;  
ELITE WHOLESALE MEDICAL SUPPLIES, INC.
DALLAS,  TX ,  US.
ELITE, INC.
CARROLLTON,  TX,  US.
Initial Importer;  
ELITE, INC.
CARROLLTON,  TX ,  US.
ELITE-ELAN COMPANY, LTD.
TAIPEI,  TW.
Manufacturer;  
ELITE-ELAN COMPANY, LTD.
TAIPEI,  TW.
ELITEX METAL GROUP MFG. CORP.
MIN HSIUNG SHIANG, CHAIYI,  TW.
Manufacturer;  
ELITEX METAL GROUP MFG. CORP.
MIN HSIUNG SHIANG, CHAIYI,  TW.
ELJAY ENT.
NEW YORK,  NY,  US.
Initial Importer;  
ELJAY ENT.
NEW YORK,  NY ,  US.
ELK CORP.
BUNKYO-KU, TOKYO,  JA.
Specification Developer;  
ELK CORP.
BUNKYO-KU, TOKYO,  JA.
ELLAB A.S.
ROEDOVRE,  DA.
Manufacturer;  
ELLAB A.S.
ROEDOVRE,  DA.
ELLENDALE RADIOLOGY
MONTREAL, QUEBEC,  CA.
Manufacturer;  
ELLENDALE RADIOLOGY
MONTREAL, QUEBEC,  CA.
ELLEVI S.R.L.
PIAZZANO DI ATESSA (CH),  IT.
Manufacturer;  
ELLEVI S.R.L.
PIAZZANO DI ATESSA (CH),  IT.
ELLEVI SAS
BELLUNO,  IT.
Unregistered Foreign Lister;  
ELLEVI SAS
BELLUNO,  IT.
ELLEX MEDICAL PTY. LTD.
ADELAIDE, SOUTH AUSTRALIA,  AS.
Contract Manufacturer;   Manufacturer;  
ELLEX MEDICAL PTY. LTD.
ADELAIDE, SOUTH AUSTRALIA,  AS.

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Last Modified: 29 April 2006
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