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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
INDUSTRIAS ASOCIADAS MAQUILADORES S.A. DE C.V.
MEXICALI,B.C.,  MX.
Manufacturer;  
MASIMO CORPORATION
IRVINE,  CA ,  US.
INDUSTRIAS DE OPTICA S.A.
BARCELONA,  SP.
Manufacturer;  
INDUSTRIAS DE OPTICA S.A.
BARCELONA,  SP.
INDUSTRIAS HUDSON, TELEFLEX MEDICAL
ENSENDA, B.C.,  MX.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
TELEFLEX MEDICAL
BANNOCKBURN,  IL ,  US.
INDUSTRIAS MANUFACTURERAS DE TAMAULIPAS S.A.DE C.V
CHINA, NUEVO LEON,  MX.
Contract Manufacturer;  
INDUSTRIAS MANUFACTURERAS DE TAMAULIPAS S.A.DE C.V
CHINA,NUEVO LEON,  MX.
INDUSTRIAS MEDICAS SAMPEDRO S.A.
SABANETA, ANTIOQUIA,  CO.
Manufacturer;  
INDUSTRIAS MEDICAS SAMPEDRO S.A.
SABANETA, ANTIOQUIA,  CO.
INDUSTRIAS METALICAS LOS PINOS SA
ITAGUI, ANTIOQUIA,  CO.
Manufacturer;  
INDUSTRIAS METALICAS LOS PINOS SA
ITAGUI, ANTIOQUIA,  CO.
INDUSTRIAS PLASTICAS MEDICAS, S.A. DE C.V.
MEXICO CITY,  MX.
Contract Manufacturer;   Contract Sterilizer;  
INDUSTRIAS PLASTICAS MEDICAS, S.A. DE C.V.
MEXICO CITY,  MX.
INDUSTRIAS TEXTILES EI CURU, S.A.
SAN JOSE,  CS.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
INDUSTRIAS TEXTILES EI CURU, S.A.
SAN JOSE,  CS.
INDUSTRIAS TUK, S.A. DE C.V.
APODACA, N.L.,  MX.
Manufacturer;  
INDUSTRIAS TUK, S.A. DE C.V.
APODACA, N.L.,  MX.
INDUSTRIAS VELASQUEZ
DE,PARACUELLOS DEJARAMA MADRID,  SP.
Unregistered Foreign Lister;  
INDUSTRIAS VELASQUEZ
DE,PARACUELLOS DEJARAMA MADRID,  SP.
INDUSTRIE BORLA S.P.A.
MONCALIERI/TORINO,  IT.
Manufacturer;  
INDUSTRIE BORLA S.P.A.
MONCALIERI/TORINO,  IT.
INDUSTRIE OTTICHE EUROPEE S.P.A.
IT GARONE BELLUNO,  IT.
Unregistered Foreign Lister;  
INDUSTRIE OTTICHE EUROPEE S.P.A.
IT GARONE BELLUNO,  IT.
INDUSTRIES FOR THE BLIND, INC.
MILWAUKEE,  WI,  US.
Initial Importer;   Repackager/Relabeller;  
INDUSTRIES FOR THE BLIND, INC.
MILWAUKEE,  WI ,  US.
INDUSTRIES OF THE BLIND, INC.
GREENSBORO,  NC,  US.
Manufacturer;  
GREENSBORO INDUSTRIES OF THE BLIND
GREENSBORO,  NC ,  US.
INDUSTRY FIRE & SAFETY EQUIPMENT, INC.
BIRMINGHAM,  AL,  US.
Initial Importer;  
INDUSTRY FIRE & SAFETY EQUIPMENT, INC.
BIRMINGHAM,  AL ,  US.
INDY INDUSTRIES
CAMARILLO,  CA,  US.
Initial Importer;  
INDY INDUSTRIES
CAMARILLO,  CA ,  US.
INEARSET, INC.
PARMA,  OH,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
INEARSET, INC.
PARMA,  OH ,  US.
INFAB CORP.
CAMARILLO,  CA,  US.
Manufacturer;  
INFAB CORP.
CAMARILLO,  CA ,  US.
INFA-LAB, INC.
ROCKAWAY,  NJ,  US.
Repackager/Relabeller;  
INFA-LAB, INC.
ROCKAWAY,  NJ ,  US.
INFAMED LTD.
PERTH, WESTERN AUSTRALIA,  AS.
Manufacturer;   Specification Developer;  
VISIO MED GROUP LIMITED
PERTH, WESTERN AUSTRALIA,  AS.
INFANT WORLD LTD.
SONGKHLA,  TH.
Manufacturer;  
INFANT WORLD LTD.
SONGKHLA,  TH.
INFECTION CONTROL TECHNOLOGY
WOODS CROSS,  UT,  US.
Repackager/Relabeller;  
INFECTION CONTROL TECHNOLOGY
WOODS CROSS,  UT ,  US.
INFECTIOUS CONTROL BAG MFG. CO., INC.
HILLSIDE,  IL,  US.
Manufacturer;  
INFECTIOUS CONTROL BAG MFG. CO., INC.
HILLSIDE,  IL ,  US.
INFIL, S.P.A.
NOVARA,  IT.
Unregistered Foreign Lister;  
INFIL, S.P.A.
NOVARA,  IT.
INFIMED, INC.
LIVERPOOL,  NY,  US.
Manufacturer;  
INFIMED, INC.
LIVERPOOL,  NY ,  US.
INFINITE CONCEPTS, INC.
WILLOW SPRINGS,  IL,  US.
Manufacturer;  
INFINITE CONCEPTS, INC.
WILLOW SPRINGS,  IL ,  US.
INFINITE PRODUCTS, INC.
CARSON,  CA,  US.
Initial Importer;  
INFINITE PRODUCTS, INC.
CARSON,  CA ,  US.
INFINITT CO., LTD.
SEOCHO-GU, SEOUL,  KS.
Manufacturer;  
INFINITT CO., LTD.
SEOCHO-GU, SEOUL,  KS.
INFINITY BUSINESS INTERNATIONAL
HOUSTON,  TX,  US.
Initial Importer;   Repackager/Relabeller;  
INFINITY BUSINESS INTERNATIONAL
HOUSTON,  TX ,  US.
INFINITY GLOBAL MEDICAL SUPPLIES, LLC
VIENNA,  VA,  US.
Initial Importer;  
INFINITY GLOBAL MEDICAL SUPPLIES, LLC
VIENNA,  VA ,  US.
INFINITY SURGICAL TECHNOLOGY, INC.
MEQUON,  WI,  US.
Specification Developer;  
INFINITY SURGICAL TECHNOLOGY, INC.
MEQUON,  WI ,  US.
INFINIUM MEDICAL
CLEARWATER,  FL,  US.
Repackager/Relabeller;  
INFINIUM MEDICAL
CLEARWATER,  FL ,  US.
INFLATION SYSTEMS, INC.
MAMARONECK,  NY,  US.
Manufacturer;  
INFLATION SYSTEMS, INC.
MAMARONECK,  NY ,  US.
INFLOW DYNAMICS, AG
MUNICH,  GM.
Unregistered Foreign Lister;  
INFLOW DYNAMICS, AG
MUNICH,  GM.
INFLUENCE MEDICAL TECHNOLOGIES, LTD.
HERZLIYA B,  IS.
Manufacturer;  
INFLUENCE MEDICAL TECHNOLOGIES, LTD.
HERZELIYA,  IS.
INFLUENT LTD.
HERZLIA,  IS.
Manufacturer;  
INFLUENT LTD.
HERZLIA,  IS.
INFLUENT MEDICAL, LLC.
CONCORD,  NH,  US.
Initial Importer;   Specification Developer;  
INFLUENT MEDICAL, LLC.
CONCORD,  NH ,  US.
INFLUX MFG., SDN. BHD.
MALACCA,  MY.
Manufacturer;  
INFLUX MFG., SDN. BHD.
MALACCA,  MY.
INFODYNE SYSTEMS
SECURITY,  CO,  US.
Manufacturer;  
INFODYNE SYSTEMS
SECURITY,  CO ,  US.
INFOPIA CO., LTD
ANYANG KVUNGGI,  KS.
Manufacturer;  
INFOPIA CO., LTD
ANYANG.KVUNGGI,  KS.

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Last Modified: 29 April 2006
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