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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
ERGODYNE CORP.
ST. PAUL,  MN,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
ERGODYNE CORP.
ST. PAUL,  MN ,  US.
ERGOGENESIS, LLC
NAVASOTA,  TX,  US.
Manufacturer;  
ERGOGENESIS, LLC
NAVASOTA,  TX ,  US.
ERGOLET A/S
KORSOR,  DA.
Manufacturer;  
ERGOLET A/S
KORSOR,  DA.
ERGOLINE GMBH
BITZ, B-W,  GM.
Manufacturer;  
ERGOLINE GMBH
BITZ, B-W,  GM.
ERGOMED MEDIZINTECHNIK
DORTMUND,  GM.
Manufacturer;  
ERGOMED MEDIZINTECHNIK
DORTMUND,  GM.
ERGOMED, INC.
SAN ANTONIO,  TX,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
ERGOMED, INC.
SAN ANTONIO,  TX ,  US.
ERGON SUTRAMED S.R.L.
MAGLIANO DEIMARSI (AQ),  IT.
Manufacturer;  
ERGON SUTRAMED S.R.L.
MAGLIANO DEIMARSI (AQ),  IT.
ERGONOMIC SEATING & PRODUCTS, INC.
DANVILLE,  CA,  US.

ERGONOMIC SEATING & PRODUCTS, INC.
DANVILLE,  CA ,  US.
ERGONOMICALLY CORRECT CONDOMS
SEATTLE,  WA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ERGONOMICALLY CORRECT CONDOMS
SEATTLE,  WA ,  US.
ERGORESEARCH INC.
MONTREAL, QUEBEC,  CA.
Manufacturer;  
ERGORESEARCH INC.
MONTREAL, QUEBEC,  CA.
ERGOTECH, INC.
HUDSON,  WI,  US.
Manufacturer;  
ERGOTECH, INC.
HUDSON,  WI ,  US.
ERGOTEK INTERNATIONAL
SIALKOT, PUNJAB,  PK.
Contract Manufacturer;  
ERGOTEK INTERNATIONAL
SIALKOT, PUNJAB,  PK.
ERHARD RIEDE
EMMINGEN-LIPTINGEN,  GM.
Manufacturer;  
ERHARD RIEDE
EMMINGEN-LIPTINGEN,  GM.
ERIC (ASIA) LIMITED
QUEEN'S ROAD CENTRAL,  HK.
Unregistered Foreign Lister;  
ERIC (ASIA) LIMITED
QUEEN'S ROAD CENTRAL,  HK.
ERIC PROST DIFFUSION
SAINT-GERMAIN-LES-ARLAY,  FR.
Specification Developer;  
ERIC PROST DIFFUSION
SAINT-GERMAIN-LES-ARLAY,  FR.
ERICA OPTICAL CO.
SAKAI GUN, FUKUI-PREF,  JA.
Manufacturer;  
ERICA OPTICAL CO.
SAKAIGUN, FUKUI-PREF.,  JA.
ERICKSON LABS NORTHWEST
KIRKLAND,  WA,  US.
Manufacturer;  
ERICKSON LABS NORTHWEST
KIRKLAND,  WA ,  US.
ERIC'S IMPORT / EXPORT & MFG.
BRONX,  NY,  US.
Initial Importer;   Specification Developer;  
ERIC'S IMPORT / EXPORT & MFG.
BRONX,  NY ,  US.
ERIE MEDICAL
PLEASANT PRAIRIE,  WI,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OCENCO, INC.
PLEASANT PRAIRIE,  WI ,  US.
ERIE SCIENTIFIC CO.
PORTSMOUTH,  NH,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
FISHER SCIENTIFIC CO., LLC.
PITTSBURGH,  PA ,  US.
ERIE SCIENTIFIC HUNGARY KFT
BUDAPEST,  HU.
Manufacturer;  
FISHER SCIENTIFIC CO., LLC.
PITTSBURGH,  PA ,  US.
ERIGON
ROBSTOWN,  TX,  US.
Manufacturer;  
ERIGON
ROBSTOWN,  TX ,  US.
ERIKA DE REYNOSA, S.A. DE C.V.
CD, REYNOSA, TAMPS,  MX.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
FRESENIUS MEDICAL CARE HOLDINGS, INC.
LEXINGTON,  MA ,  US.
ERILENS S.R.O.
PRAGUE,  EZ.
Manufacturer;  
ERILENS S.R.O.
PRAGUE,  EZ.
ERIO SYSTEM
SARATOGA,  CA,  US.
Initial Importer;  
ERIO SYSTEM
SARATOGA,  CA ,  US.
ERIS MEDICAL TECHNOLOGY
BERKELEY HEIGHTS,  NJ,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
SRS MEDICAL CORP.
BERKELEY HEIGHTS,  NJ ,  US.
ERKER'S FINE EYEWEAR
ST. LOUIS,  MO,  US.
Initial Importer;  
ERKER'S FINE EYEWEAR
ST. LOUIS,  MO ,  US.
ERKODENT ERICH KOPP GMBH DENTALFABRIKATION
PFALZGRAFENWEILER,  GM.
Manufacturer;  
ERKODENT ERICH KOPP GMBH DENTALFABRIKATION
PFALZGRAFENWEILER,  GM.
ERMI, INC.
DECATUR,  GA,  US.
Specification Developer;  
ERMI, INC.
DECATUR,  GA ,  US.
ERMO
BUENOS AIRES,  AR.
Unregistered Foreign Lister;  
ERMO
BUENOS AIRES,  AR.
ERNEST ZAVORAL
CANFIELD,  OH,  US.
Specification Developer;  
ERNEST ZAVORAL
CANFIELD,  OH ,  US.
ERNST DINGER E.K.
SOLINGEN,  GM.
Manufacturer;  
ERNST DINGER E.K.
SOLINGEN,  GM.
ERNST KRAUSKOPF
SOLINGEN,  GM.
Contract Manufacturer;   Manufacturer;  
ERNST KRAUSKOPF
SOLINGEN,  GM.
ERNST L.ZEPF, INH. MAX MULLER
TUTTLINGEN,  GM.
Manufacturer;  
ERNST L.ZEPF, INH. MAX MULLER
TUTTLINGEN,  GM.
EROICA CORP.
SEOUL,  KS.
Manufacturer;  
EROICA CORP.
SEOUL,  KS.
ERSKINE DENTAL
MACKSVILLE, NSW,  AS.
Foreign Exporter;   Specification Developer;  
ERSKINE PRODUCTS PTY. LTD.
SYDNEY, NSW,  AS.
ERTCO
WALNUT,  CA,  US.
Initial Importer;  
ERTCO
WALNUT,  CA ,  US.
ERWIN HABERER
TUTTLINGEN-16-7200,  GM.
Manufacturer;  
ERWIN HABERER
TUTTLINGEN-16-7200,  GM.
ERWIN KOWSKY GMBH & CO.KG
SCHLESWIG-HOLSTEIN,  GM.
Manufacturer;  
ERWIN KOWSKY GMBH & CO.KG
SCHLESWIG-HOLSTEIN,  GM.
ERYMARK SA DE C.V.
MERIDA, YUCATAN,  MX.
Manufacturer;   Specification Developer;  
ERYMARK SA DE C.V.
MERIDA, YUCATAN,  MX.

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Last Modified: 29 April 2006
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