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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
ISOMEDIX OPERATIONS INC.
SPARTANBURG,  SC,  US.
Contract Sterilizer;  
STERIS CORPORATION
MENTOR,  OH ,  US.
ISOMEDIX OPERATIONS INC.
VEGA ALTA,  PR,  US.
Contract Sterilizer;  
STERIS CORPORATION
MENTOR,  OH ,  US.
ISOMEDIX OPERATIONS INC.
VILLAGE OF CHESTER,  NY,  US.
Contract Sterilizer;  
STERIS CORPORATION
MENTOR,  OH ,  US.
ISOMEDIX OPERATIONS INC.
WHIPPANY,  NJ,  US.
Contract Sterilizer;  
STERIS CORPORATION
MENTOR,  OH ,  US.
ISOPURE CORP.
SIMPSONVILLE,  KY,  US.
Manufacturer;  
ISOPURE CORP.
SIMPSONVILLE,  KY ,  US.
ISOTIS LLC
FLOURTOWN,  PA,  US.
Initial Importer;  
ISOTIS SA
LAUSANNE,  SZ.
ISOTIS NV
BILTHOVEN,  NL.
Manufacturer;  
ISOTIS SA
LAUSANNE,  SZ.
ISOTIS ORTHOBIOLOGICS, INC
IRVINE,  CA,  US.
Initial Importer;   Manufacturer;  
ISOTIS SA
LAUSANNE,  SZ.
ISOTOPE PRODUCTS LABORATORIES
BURBANK,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ISOTOPE PRODUCTS LABORATORIES
VALENCIA,  CA ,  US.
ISOTOPE PRODUCTS LABORATORIES
VALENCIA,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ISOTOPE PRODUCTS LABORATORIES
VALENCIA,  CA ,  US.
ISOTRON (THAILAND) LTD.
MUANG, CHONBURI,  TH.
Contract Sterilizer;  
ISOTRON (THAILAND) LTD.
MUANG, CHONBURI,  TH.
ISOTRON DEUTSCHLAND GMBH
ALLERSHAUSEN,  GM.
Contract Sterilizer;  
ISOTRON DEUTSCHLAND GMBH
ALLERSHAUSEN,  GM.
ISOTRON IRELAND LTD.
TULLAMORE CO. OFFALY,  EI.
Contract Sterilizer;  
ISOTRON IRELAND LTD.
TULLAMORE CO. OFFALY,  EI.
ISOTRON NEDERLAND B.V.
EDE,  NL.
Contract Sterilizer;  
ISOTRON NEDERLAND B.V.
EDE,  NL.
ISOTRON STERILISATION MALAYSIA SDN BHD
KUALA KETAL, KEDAH,  MY.
Contract Sterilizer;  
ISOTRON, PLC
SWINDON, WILTSHIRE,  UK.
ISOTRON WESTPORT LTD
WESTPORT,  EI.
Contract Sterilizer;  
ISOTRON WESTPORT LIMITED
WESTPORT,  EI.
ISOTRON, PLC
SWINDON, WILTS.,  UK.
Contract Sterilizer;  
ISOTRON, PLC
SWINDON, WILTSHIRE,  UK.
ISOTRON, PLC
THORNE, DONCASTER,  UK.
Contract Sterilizer;  
ISOTRON, PLC
THORNE, DONCASTER,  UK.
ISP TECHNOLOGIES, INC.
WAYNE,  NJ,  US.
Specification Developer;  
ISP TECHNOLOGIES, INC.
WAYNE,  NJ ,  US.
ISPEX CO., LTD.
TAICHUNG,  TW.
Manufacturer;  
ISPEX CO., LTD.
TAICHUNG,  TW.
ISPG, INC.
NEW MILFORD,  CT,  US.
Initial Importer;  
ISPG, INC.
NEW MILFORD,  CT ,  US.
ISSAQUAH DENTAL LAB, INC.
ISSAQUAH,  WA,  US.
Repackager/Relabeller;  
ISSAQUAH DENTAL LAB, INC.
ISSAQUAH,  WA ,  US.
IST DIVING SYSTEM
AZUSA,  CA,  US.
Initial Importer;  
IST DIVING SYSTEM
AZUSA,  CA ,  US.
I-STAT CANADA LTD.
KANATA, ONTARIO,  CA.
Manufacturer;   Specification Developer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
I-STAT CANADA LTD.
NEPEAN, ONTARIO,  CA.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
I-STAT CORP.
EAST WINDSOR,  NJ,  US.
Manufacturer;   Specification Developer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ISURGICAL
COUNTRYSIDE LAKE,  IL,  US.
Manufacturer;   Specification Developer;  
ISURGICAL
COUNTRYSIDE LAKE,  IL ,  US.
ISW INTERNATIONAL, INC.
ATLANTIC BEACH,  FL,  US.
Initial Importer;  
ISW INTERNATIONAL, INC.
ATLANTIC BEACH,  FL ,  US.
IT DR. GAMBERT GMBH
WISMAR, M-V,  GM.
Manufacturer;  
IT DR. GAMBERT GMBH
WISMAR, M-V,  GM.
ITALEE OPTICS, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
ITALEE OPTICS, INC.
LOS ANGELES,  CA ,  US.
ITALIAN DESIGN, SNC
TAI DI CADORE (BELLUNO),  IT.
Manufacturer;  
ELEONORA PICCIN
NEBBIU (BELLUNO),  IT.
ITALIAN EYES, L.L.C.
MATTOON,  IL,  US.
Initial Importer;  
ITALIAN EYES, L.L.C.
MATTOON,  IL ,  US.
ITALIAN EYEWEAR, INC.
MIAMI,  FL,  US.
Initial Importer;  
ITALIAN EYEWEAR, INC.
MIAMI,  FL ,  US.
ITALIAN FRAMES
ASTORIA,  NY,  US.
Initial Importer;  
ITALIAN FRAMES
ASTORIA,  NY ,  US.
ITALIAN STYLE S.R.L.
SCANDICCI (FI),  IT.
Manufacturer;  
ITALIAN STYLE S.R.L.
SCANDICCI (FI),  IT.
ITALIANA OCCHIALI DESIGN S.R.L.
TREVISO,  IT.
Manufacturer;  
ITALIANA OCCHIALI DESIGN S.R.L.
TREVISO,  IT.
ITALIANA OCCHIALI DESIGNS, INC.
VALHALLA,  NY,  US.
Initial Importer;  
ITALIANA OCCHIALI DESIGNS, INC.
VALHALLA,  NY ,  US.
ITALO CREMONA S.P.A.
GAZZADA-SCHIANNO,  IT.
Manufacturer;  
ITALO CREMONA S.P.A.
GAZZADA-SCHIANNO,  IT.
ITALROMEDICA
VOLUNTARI LLFOV,  RO.
Contract Manufacturer;  
ITALROMEDICA
VOLUNTARI LLFOV,  RO.
ITALSAN S.P.A.
SILVI MARINA(TERAMO),  IT.
Manufacturer;  
ITALSAN S.P.A.
SILVI MARINA(TERAMO),  IT.

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Last Modified: 29 April 2006
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