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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
MEDELEX, INC.
SUNNYVALE,  CA,  US.
Manufacturer;  
MEDELEX, INC.
SUNNYVALE,  CA ,  US.
MEDENNIUM, INC.
IRVINE,  CA,  US.
Contract Manufacturer;   Manufacturer;  
MEDENNIUM, INC.
IRVINE,  CA ,  US.
MEDENTAL INTL.
VISTA,  CA,  US.
Initial Importer;   Contract Manufacturer;   Repackager/Relabeller;  
MEDENTAL INTL.
VISTA,  CA ,  US.
MED-E-PLAN CONSULTING GMBH
RODGAU 3,  GM.
Unregistered Foreign Lister;  
MED-E-PLAN CONSULTING GMBH
RODGAU 3,  GM.
MED-E-QUIP LOCATORS, INC.
SAINT LOUIS,  MO,  US.
Repackager/Relabeller;  
MED-E-QUIP LOCATORS, INC.
SAINT LOUIS,  MO ,  US.
MEDER
TUTTLINGEN,  GM.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDER
TUTTLINGEN,  GM.
MEDER DISTRIBUTING, INC.
HANNA,  IN,  US.
Initial Importer;  
MEDER DISTRIBUTING, INC.
HANNA,  IN ,  US.
MEDESY S.R.L.
MANIAGO,  IT.
Manufacturer;  
MEDESY S.R.L.
MANIAGO,  IT.
MEDETRADE INTL.
SAMBRIAL-SIALKOT,  PK.
Manufacturer;  
MEDETRADE INTL.
SAMBRIAL-SIALKOT,  PK.
MED-EUROPE S.R.L.
SAN PIETRO IN CASALE, BOLOGNA,  IT.
Manufacturer;  
MED-EUROPE S.R.L.
SAN PIETRO IN CASALE, BOLOGNA,  IT.
MEDEVCO, INC.
DALLAS,  TX,  US.
Specification Developer;  
MEDEVCO, INC.
DALLAS,  TX ,  US.
MEDEVICE CORPORATION
SAN JUAN,  PR,  US.
Manufacturer;  
MEDEVICE CORPORATION
SAN JUAN,  PR ,  US.
MEDEVICE, INC.
CANADA L4W 4M2,  CA.
Unregistered Foreign Lister;  
MEDEVICE, INC.
CANADA L4W 4M2,  CA.
MEDEVICES, INC.
GRAYSLAKE,  IL,  US.
Manufacturer;   Specification Developer;  
MEDEVICES, INC.
GRAYSLAKE,  IL ,  US.
MEDEX CARDIO-PULMONARY
VERNON HILLS,  IL,  US.
Manufacturer;  
SMITHS GROUP PLC
LONDON,  UK.
MEDEX DE MEXICO, S.A. DE C.V.
APODACA, NL,  MX.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SMITHS GROUP PLC
LONDON,  UK.
MEDEX GMBH
FRAUREUTH,  GM.
Manufacturer;  
SMITHS GROUP PLC
LONDON,  UK.
MEDEX INC.
CARLSBAD,  CA,  US.
Specification Developer;   Repackager/Relabeller;  
SMITHS GROUP PLC
LONDON,  UK.
MEDEX INTERNATIONAL LTD.
CITY, SHANGHAI,  CH.
Foreign Exporter;  
MEDEX INTERNATIONAL LTD.
CITY, SHANGHAI,  CH.
MEDEX MARKETING, INC.
BILLERICA,  MA,  US.
Specification Developer;  
MEDEX MARKETING, INC.
BILLERICA,  MA ,  US.
MEDEX MEDICAL LTD.
ROSSENDALE, LANCASHIER,  UK.
Manufacturer;  
SMITHS GROUP PLC
LONDON,  UK.
MEDEX PARA-MEDICAL EQUIPMENT, INC.
LE GARDEUR, QUEBEC,  CA.
Manufacturer;  
MEDEX PARA-MEDICAL EQUIPMENT, INC.
LE GARDEUR, QUEBEC,  CA.
MEDEX SYSTEMS INTL., INC.
ALDERGROVE, B.C.,  CA.
Manufacturer;  
MED*EX DIAGNOSTICS OF CANADA, INC.
ALDERGROVE, B.C.,  CA.
MEDEX VASCULAR ACCESS
SOUTHINGTON,  CT,  US.
Manufacturer;  
SMITHS GROUP PLC
LONDON,  UK.
MEDEX, INC.
DUBLIN,  OH,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
SMITHS GROUP PLC
LONDON,  UK.
MEDEX, INC.
DULUTH,  GA,  US.
Manufacturer;  
SMITHS GROUP PLC
LONDON,  UK.
MEDEXCHANGE INTERNATIONAL, INC.
AQAWAM,  MA,  US.
Initial Importer;  
MEDEXCHANGE INTERNATIONAL, INC.
AQAWAM,  MA ,  US.
MEDEXEL MEDICAL MFG. CO., LTD.
SEOUL,  KS.
Manufacturer;  
MEDEXEL MEDICAL MFG. CO., LTD.
SEOUL,  KS.
MED-EXPRESS, INC.
HORSESHOE,  NC,  US.
Initial Importer;  
MED-EXPRESS, INC.
HORSESHOE,  NC ,  US.
MEDEXUS INC.
MISSISSAUGA, ONTARIO,  CA.
Manufacturer;   Specification Developer;  
MEDEXUS INC.
MISSISSAUGA, ONTARIO,  CA.
MEDFAXX, INC.
WAKE FOREST,  NC,  US.
Specification Developer;   Repackager/Relabeller;  
MEDFAXX, INC.
WAKE FOREST,  NC ,  US.
MED-FIT SYSTEMS, INC.
FALLBROOK,  CA,  US.
Initial Importer;  
MED-FIT SYSTEMS, INC.
FALLBROOK,  CA ,  US.
MEDGAL
BIALYSTOK,  PL.
Manufacturer;  
MEDGAL
BIALYSTOK,  PL.
MEDGE PLATFORMS, INC.
NEW YORK,  NY,  US.
Manufacturer;  
MEDGE PLATFORMS, INC.
NEW YORK,  NY ,  US.
MED-GENERAL USA LLC
NAPLES,  FL,  US.
Manufacturer;   Specification Developer;  
MED-GENERAL USA LLC
NAPLES,  FL ,  US.
MEDGLUV, INC.
FORT LAUDERDALE,  FL,  US.
Initial Importer;  
MEDGLUV, INC.
FORT LAUDERDALE,  FL ,  US.
MEDGUARD LLC
CONCORD,  NC,  US.
Contract Manufacturer;  
MEDGUARD LLC
CONCORD,  NC ,  US.
MEDGYN PRODUCTS, INC.
LOMBARD,  IL,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
MEDGYN PRODUCTS, INC.
LOMBARD,  IL ,  US.
MEDI BAYREUTH
BAYREUTH, BAVARIA,  GM.
Manufacturer;  
MEDI BAYREUTH
BAYREUTH, BAVARIA,  GM.
MEDI CIVIC SURGICAL INSTRUMENTS COMPANY
SIALKOT, PUNJAB,  PK.
Manufacturer;  
MEDI CIVIC SURGICAL INSTRUMENTS COMPANY
SIALKOT, PUNJAB,  PK.

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Last Modified: 29 April 2006
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