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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
INSTRUMED GMBH
TUTTLINGEN,  GM.
Manufacturer;  
INSTRUMED GMBH
TUTTLINGEN,  GM.
INSTRUMED INTERNATIONAL, INC.
SCHAUMBURG,  IL,  US.
Repackager/Relabeller;  
INSTRUMED INTERNATIONAL, INC.
SCHAUMBURG,  IL ,  US.
INSTRUMED, INC.
WOODINVILLE,  WA,  US.
Manufacturer;  
INSTRUMED, INC.
WOODINVILLE,  WA ,  US.
INSTRU-MED, INC.
ATLANTA,  GA,  US.
Initial Importer;   Remanufacturer;  
INSTRU-MED, INC.
ATLANTA,  GA ,  US.
INSTRUMEDICAL TECHNOLOGIES, INC.
WARSAW,  IN,  US.
Contract Manufacturer;  
INSTRUMEDICAL TECHNOLOGIES, INC.
WARSAW,  IN ,  US.
INSTRUMEK BV
SCHIEDAM ZUID-HOLLAND,  NL.
Contract Manufacturer;  
INSTRUMEK BV
SCHIEDAM ZUID-HOLLAND,  NL.
INSTRUMENT OUTSOURCING SERVICE, INC
BUTLER,  PA,  US.
Initial Importer;  
INSTRUMENT OUTSOURCING SERVICE, INC
BUTLER,  PA ,  US.
INSTRUMENT SPECIALISTS, INC.
BOERNE,  TX,  US.
Manufacturer;  
INSTRUMENT SPECIALISTS, INC.
BOERNE,  TX ,  US.
INSTRUMENT TECHNOLOGY, INC.
WESTFIELD,  MA,  US.
Contract Manufacturer;   Manufacturer;  
INSTRUMENT TECHNOLOGY, INC.
WESTFIELD,  MA ,  US.
INSTRUMENTAL MACHINE & DEVELOPMENT, LLC.
WARSAW,  IN,  US.
Contract Manufacturer;  
INSTRUMENTAL MACHINE & DEVELOPMENT, LLC.
WARSAW,  IN ,  US.
INSTRUMENTARIUM DENTAL INC.
MILWAUKEE,  WI,  US.
Initial Importer;  
PALODEX GROUP OY
TUUSULA,  FI.
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
TUUSULA, FINLAND,  FI.
Manufacturer;  
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
TUUSULA, FINLAND,  FI.
INSTRUMENTARIUM SURGICAL CORP., INC.
TERREBONNE (QUEBEC),  CA.
Repackager/Relabeller;  
INSTRUMENTARIUM SURGICAL CORP., INC.
TERREBONNE (QUEBEC),  CA.
INSTRUMENTATION ASSOC., INC.
BROOMALL,  PA,  US.
Initial Importer;  
INSTRUMENTATION ASSOC., INC.
BROOMALL,  PA ,  US.
INSTRUMENTATION FOR MEDICINE, INC.
OLD GREENWICH,,  CT,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
INSTRUMENTATION FOR MEDICINE, INC.
OLD GREENWICH,,  CT ,  US.
INSTRUMENTATION INDUSTRIES, INC.
BETHEL PARK,  PA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
INSTRUMENTATION INDUSTRIES, INC.
BETHEL PARK,  PA ,  US.
INSTRUMENTATION LABORATORY CO.
LEXINGTON,  MA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
INSTRUMENTATION LABORATORY CO.
LEXINGTON,  MA ,  US.
INSTRUMENTATION LABORATORY CO.
ORANGEBURG,  NY,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;   U.S. Manufacturer of Export Only Devices;
INSTRUMENTATION LABORATORY CO.
LEXINGTON,  MA ,  US.
INSTRUMENTS & EQUIPMENT CO.
SPARTA,  NJ,  US.
Initial Importer;  
INSTRUMENTS & EQUIPMENT CO.
SPARTA,  NJ ,  US.
INSTRUMENTS 4 VISION, INC.
GARDEN CITY,  MI,  US.
Initial Importer;  
INSTRUMENTS 4 VISION, INC.
GARDEN CITY,  MI ,  US.
INSTRUMENTS MEDICAUX G.B., INC.
SHERBROOKE, QUEBEC,  CA.
Manufacturer;   Specification Developer;  
INSTRUMENTS MEDICAUX G.B., INC.
SHERBROOKE, QUEBEC,  CA.
INSTRUMENTS OF SWEDEN, INC.
STAMFORD,  CT,  US.
Manufacturer;   Specification Developer;  
INSTRUMENTS OF SWEDEN, INC.
STAMFORD,  CT ,  US.
INSTRUMENTS ONLINE (PVT.) LTD.
SIALKOT CANTT,  PK.
Unregistered Foreign Lister;  
INSTRUMENTS ONLINE (PVT.) LTD.
SIALKOT CANTT,  PK.
INSTYLE
ISEHARA, KANAGAWA,  JA.
Foreign Exporter;   Manufacturer;  
INSTYLE
ISEHARA, KANAGAWA,  JA.
INSTYLE OPTIQUE INC.
AVENTURA,  FL,  US.
Initial Importer;  
INSTYLE OPTIQUE INC.
AVENTURA,  FL ,  US.
INSULET CORPORATION
BEDFORD,  MA,  US.
Manufacturer;  
INSULET CORPORATION
BEDFORD,  MA ,  US.
INSUNG ELECTRONICS CO., LTD.
SUWON, KYUNGKI-DO,  KS.
Contract Manufacturer;  
INSUNG ELECTRONICS CO., LTD.
SUWON, KYUNGKI-DO,  KS.
INTACT MEDICAL CORPORATION
NATICK,  MA,  US.
Specification Developer;  
INTACT MEDICAL CORPORATION
NATICK,  MA ,  US.
INTAI TECHNOLOGY CORP.
TAICHUNG CITY,  TW.
Manufacturer;  
INTAI TECHNOLOGY CORP.
TAICHUNG CITY,  TW.
INTAI TECHNOLOGY INC.
TAICHUNG CITY,  TW.
Manufacturer;  
INTAI TECHNOLOGY INC.
TAICHUNG CITY,  TW.
INTARSIA LTD.
GAYLORDSVILLE,  CT,  US.
Manufacturer;  
INTARSIA LTD.
GAYLORDSVILLE,  CT ,  US.
INTCO METAL PRODUCTS (ZHENJIANG) CO., LTD.
ZHENJIANG, JIANGSU,  CH.
Manufacturer;  
INTCO METAL PRODUCTS (ZHENJIANG) CO., LTD.
ZHENJIANG, JIANGSU,  CH.
INTEC INDUSTRIES, INC.
BIRMINGHAM,  AL,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
INTEC INDUSTRIES, INC.
BIRMINGHAM,  AL ,  US.
INTEC PRODUCTS, INC. (XIAMEN)
XIAMEN FUJIAN,  CH.
Manufacturer;  
INTEC PRODUCTS, INC. (XIAMEN)
XIAMEN, FUJIAN,  CH.
INTEC X-RAY PROTECTION
HAARLEM,  NL.
Manufacturer;  
INTEC X-RAY PROTECTION
HAARLEM,  NL.
INTEC, INC.
MIAMI,  FL,  US.
Initial Importer;  
INTEC, INC.
MIAMI,  FL ,  US.
IN'TECH MEDICAL
RANG DU FLIERS,  FR.
Contract Manufacturer;   Manufacturer;  
IN'TECH MEDICAL
RANG DU FLIERS,  FR.
INTEGRA BIOTECHNICAL LLC.
VISTA,  CA,  US.
Contract Manufacturer;   Manufacturer;  
INTEGRA BIOTECHNICAL LLC.
VISTA,  CA ,  US.
INTEGRA LIFESCIENCES CORP.
PLAINSBORO,  NJ,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.
INTEGRA LIFESCIENCES CORPORATION
CINCINNATI,  OH,  US.
Manufacturer;   Specification Developer;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.

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Last Modified: 29 April 2006
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