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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
MEDTEX HOLDINGS CORP.
WUHAN,  CH.
Specification Developer;  
MEDTEX HOLDINGS CORP.
WUHAN,  CH.
MEDTEX LLC
COLONIAL HEIGHTS,  VA,  US.
Specification Developer;  
MEDTEX LLC
COLONIAL HEIGHTS,  VA ,  US.
MEDTEXX INDUSTRIES (THAI) CO. LTD.
AMPHUR BANGKLAM SONGKHLA,  TH.
Manufacturer;  
MEDTEXX INDUSTRIES (THAI) CO. LTD.
AMPHUR BANGKLAM SONGKHLA,  TH.
MEDTEXX PARTNERS, INC.
HACKENSACK,  NJ,  US.
Initial Importer;  
MEDTEXX PARTNERS, INC.
HACKENSACK,  NJ ,  US.
MEDTORQUE INC.
RACINE,  WI,  US.
Contract Manufacturer;  
MEDTORQUE INC.
RACINE,  WI ,  US.
MEDTOX DIAGNOSTICS, INC.
BURLINGTON,  NC,  US.
Contract Manufacturer;   Manufacturer;  
MEDTOX DIAGNOSTICS, INC.
BURLINGTON,  NC ,  US.
MEDTOX DIAGNOSTICS, INC.
BURLINGTON,  NC,  US.
Contract Manufacturer;   Manufacturer;  
MEDTOX DIAGNOSTICS, INC.
BURLINGTON,  NC ,  US.
MEDTRADE PRODUCTS LTD.
CHESHIRE,  UK.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
MEDTRADE PRODUCTS LTD.
CHESHIRE,  UK.
MEDTREO, LLC
SAINT PAUL,  MN,  US.
Specification Developer;  
MEDTREO, LLC
SAINT PAUL,  MN ,  US.
MEDTRO GMBH
LEIMEN-GAV,  GM.
Manufacturer;  
MEDTRO GMBH
LEIMEN-GAV,  GM.
MEDTROL, INC.
NILES,  IL,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
MEDTROL, INC.
NILES,  IL ,  US.
MEDTRONIC A/S
SKOVLUNDE,  DA.
Manufacturer;   Specification Developer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC B.V.
HERLEEN,  NL.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC BLOOD MANAGEMENT
PARKER,  CO,  US.
Manufacturer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
MINNEAPOLIS,  MN,  US.
Specification Developer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
REDMOND,  WA,  US.
Manufacturer;   Specification Developer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC EP SYSTEMS
MINNEAPOLIS,  MN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC EUROPEAN OPERATIONS CENTER
HOLLAND,  NL.
Manufacturer;  
MEDTRONIC EUROPEAN OPERATIONS CENTER
HOLLAND,  NL.
MEDTRONIC FRANCE S.A.
FOURMIES,  FR.
Manufacturer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC GASTROENTEROLOGY/UROLOGY
SHOREVIEW,  MN,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC GASTROENTEROLOGY/UROLOGY MGU
SHOREVIEW,  MN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC HEART VALVES
SPRING LAKE PARK,  MN,  US.
Manufacturer;   Specification Developer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC IMAGE-GUIDED NEUROLOGICS, INC.
MELBOURNE,  FL,  US.
Manufacturer;   Specification Developer;  
MEDTRONIC IMAGE-GUIDED NEUROLOGICS, INC.
MELBOURNE,  FL ,  US.
MEDTRONIC INC, PACEART
ARDEN HILLS,  MN,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT
MINNEAPOLIS,  MN,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC IRELAND
GALWAY,  EI.
Manufacturer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC MEXICO EG
EMPALME, SONORA,  MX.
Contract Manufacturer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC MEXICO, S. DE R.L. DE C.V.
TIJUANA, B.C.,  MX.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC MINIMED
NORTHRIDGE,  CA,  US.
Manufacturer;   Specification Developer;  
MEDTRONIC MINIMED
NORTHRIDGE,  CA ,  US.
MEDTRONIC NAVIGATION, INC.
LOUISVILLE,  CO,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC NEUROLOGICAL
MINNEAPOLIS,  MN,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC NEUROSURGERY
GOLETA,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC PERFUSION SYSTEMS
MINNEAPOLIS,  MN,  US.
Manufacturer;   Specification Developer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC POWERED SURGICAL SOLUTIONS
FORT WORTH,  TX,  US.
Manufacturer;   Specification Developer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL
JUNCOS,  PR,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC PUERTO RICO OPERATIONS CO., MPRI
VILLALBA,  PR,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC PUERTO RICO OPERATIONS CO.,MED REL
HUMACAO,  PR,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
DEGGENDORF,  GM.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
BARTLETT,  TN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.
MEDTRONIC SOFAMOR DANEK USA, INC.
MEMPHIS,  TN,  US.
Specification Developer;  
MEDTRONIC, INC.
MINNEAPOLIS,  MN ,  US.

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Last Modified: 29 April 2006
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