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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
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ,  US.
Initial Importer;   Specification Developer;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.
INTEGRA ME GMBH
TUTTLINGEN,  GM.
Manufacturer;   Specification Developer;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.
INTEGRA MEDICAL
CAMARILLO,  CA,  US.
Manufacturer;  
INTEGRA MEDICAL
CAMARILLO,  CA ,  US.
INTEGRA NEURO SCIENCES
SAN DIEGO,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.
INTEGRA NEUROSCIENCES IMPLANTS S.A.
SOPHIA ANTIPOLIS,  FR.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.
INTEGRA NEUROSCIENCES PR, INC.
ANASCO,  PR,  US.
Contract Manufacturer;   Manufacturer;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.
INTEGRA NEUROSCIENCES, LTD.
ANDOVER HAMPSHIRE,  UK.
Manufacturer;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.
INTEGRA RADIONICS, INC.
BURLINGTON,  MA,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.
INTEGRAL DESIGN, INC.
HINGHAM,  MA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
INTEGRAL DESIGN, INC.
HINGHAM,  MA ,  US.
INTEGRAL ORTHOPEDICS INC.
TORONTO, ONTARIO,  CA.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OBUS FORME, A DIVISION OF INTEGRAL ORTHOPEDICS INC
TORONTO, ONTARIO,  CA.
INTEGRAMED AMERICA, INC.
PURCHASE,  NY,  US.
Manufacturer;   Specification Developer;  
INTEGRAMED AMERICA, INC.
PURCHASE,  NY ,  US.
INTEGRATECH SOLUTIONS CORP.
READING,  MA,  US.
Manufacturer;  
INTEGRATECH SOLUTIONS CORP.
HUDSON,  MA ,  US.
INTEGRATED BIOMEDICAL CORP.
LAS VEGAS,  NV,  US.
Manufacturer;  
INTEGRATED BIOMEDICAL CORP.
LAS VEGAS,  NV ,  US.
INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
ELKHART,  IN,  US.
Manufacturer;  
INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
ELKHART,  IN ,  US.
INTEGRATED BIOSCIENCES INCORPORATED
LEWISBERRY,  PA,  US.
Contract Manufacturer;  
INTEGRATED BIOSCIENCES INCORPORATED
LEWISBERRY,  PA ,  US.
INTEGRATED DIAGNOSTIC AND REHAB TECHNOLOGIES LLC
SAN FRANCISCO,  CA,  US.
Initial Importer;  
INTEGRATED DIAGNOSTIC AND REHAB TECHNOLOGIES LLC
SAN FRANCISCO,  CA ,  US.
INTEGRATED DYNAMICS LTD.
FEN DRAYTON, CAMBRIDGE,  UK.
Manufacturer;  
INTEGRATED DYNAMICS LTD.
FEN DRAYTON, CAMBRIDGE,  UK.
INTEGRATED INSTRUMENTS CORP.
INDIANAPOLIS,  IN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
INTEGRATED INSTRUMENTS CORP.
INDIANAPOLIS,  IN ,  US.
INTEGRATED LAMINATE SYSTEMS, INC.
PENNSAUKEN,  NJ,  US.
Initial Importer;  
INTEGRATED LAMINATE SYSTEMS, INC.
PENNSAUKEN,  NJ ,  US.
INTEGRATED LEADERSHIP OF TECHNOLOGIES & SERVICES,
EVANS,  GA,  US.

INTEGRATED LEADERSHIP OF TECHNOLOGIES & SERVICES,
EVANS,  GA ,  US.
INTEGRATED LENS TECHNOLOGY PTE LTD
SINGAPORE,  SN.
Manufacturer;  
INTEGRATED LENS TECHNOLOGY PTE LTD
SINGAPORE,  SN.
INTEGRATED MEDICAL DEVICES, INC.
LIVERPOOL,  NY,  US.
Contract Manufacturer;   Manufacturer;  
INTEGRATED MEDICAL DEVICES, INC.
LIVERPOOL,  NY ,  US.
INTEGRATED MEDICAL SYSTEMS, INC.
LOS ANGELES,  CA,  US.
Manufacturer;  
INTEGRATED MEDICAL SYSTEMS, INC.
LOS ANGELES,  CA ,  US.
INTEGRATED MEDICAL SYSTEMS, INC.
SIGNAL HILL,  CA,  US.
Manufacturer;   Specification Developer;  
INTEGRATED MEDICAL SYSTEMS, INC.
SIGNAL HILL,  CA ,  US.
INTEGRATED MEDICAL TECHNOLOGIES
TROY,  NY,  US.
Manufacturer;   Specification Developer;  
INTEGRATED MEDICAL TECHNOLOGIES
TROY,  NY ,  US.
INTEGRATED MEDICAL TECHNOLOGIES USA, LLC
LINO LAKES,  MN,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
INTEGRATED MEDICAL TECHNOLOGIES USA, LLC
LINO LAKES,  MN ,  US.
INTEGRATED MODULAR SYSTEMS, INC.
HAVERTOWN,  PA,  US.
Initial Importer;  
INTEGRATED MODULAR SYSTEMS, INC.
HAVERTOWN,  PA ,  US.
INTEGRATED ORBITAL IMPLANTS, INC.
SAN DIEGO,  CA,  US.
Specification Developer;   Repackager/Relabeller;  
INTEGRATED ORBITAL IMPLANTS, INC.
SAN DIEGO,  CA ,  US.
INTEGRATED POWER SYSTEMS INTERNATIONAL
HENRIETTA,  NY,  US.
Remanufacturer;  
INTEGRATED POWER SYSTEMS INTERNATIONAL
HENRIETTA,  NY ,  US.
INTEGRATED RECOVERY PRODUCTS
CANTON,  OH,  US.
Initial Importer;  
INTEGRATED RECOVERY PRODUCTS
CANTON,  OH ,  US.
INTEGRATED SUPPLY CHAIN SDN. BHD.
81560 GELANG PATAH, JOHOR,  MY.
Repackager/Relabeller;  
INTEGRATED SUPPLY CHAIN SDN. BHD.
81560 GELANG PATAH, JOHOR,  MY.
INTEGRATED SURGICAL SYSTEMS, INC.
DAVIS,  CA,  US.
Manufacturer;  
INTEGRATED SURGICAL SYSTEMS, INC.
DAVIS,  CA ,  US.
INTEGRATED TECHNOLOGIES LTD.
ASHFORD, KENT,  UK.
Contract Manufacturer;  
INTEGRATED TECHNOLOGIES LTD.
ASHFORD, KENT,  UK.
INTEGRATED TECHNOLOGIES OF SOUTHWEST FLORIDA, INC.
FORT MYERS,  FL,  US.
Remanufacturer;  
INTEGRATED TECHNOLOGIES OF SOUTHWEST FLORIDA, INC.
FORT MYERS,  FL ,  US.
INTEGRATION DIAGNOSTICS LTD
GOTEBORG,  SW.
Foreign Exporter;   Specification Developer;  
INTEGRATION DIAGNOSTICS LTD
GOTEBORG,  SW.
INTEGRATION DIAGNOSTICS LTD
SAVEDALEN,  SW.
Manufacturer;  
INTEGRATION DIAGNOSTICS LTD
SAVEDALEN,  SW.
INTEGRE-MED., LLC.
ALBUQUERQUE,  NM,  US.
Manufacturer;  
INTEGRE-MED., LLC.
ALBUQUERQUE,  NM ,  US.
INTEGREX, INC.
BOTHELL,  WA,  US.
Contract Manufacturer;  
INTEGREX, INC.
BOTHELL,  WA ,  US.
INTEGRITI SYSTEMS, LLC
SEATTLE,  WA,  US.
Manufacturer;  
INTEGRITI SYSTEMS, LLC
SEATTLE,  WA ,  US.
INTEGRITY MEDICAL DEVICES INC
HAMMONTON,  NJ,  US.
Contract Manufacturer;   Manufacturer;  
INTEGRITY MEDICAL DEVICES INC
HAMMONTON,  NJ ,  US.

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Last Modified: 29 April 2006
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