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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
ARCHITECTURES
PARIS,  FR.
Manufacturer;  
ARCHITECTURES
PARIS,  FR.
ARCHTEK, INC.
LAKEWOOD,  CO,  US.
Manufacturer;  
ARCHTEK, INC.
LAKEWOOD,  CO ,  US.
ARCO MEDIC LTD.
OMER,  IS.
Manufacturer;  
ARCO MEDIC LTD.
OMER,  IS.
ARCOMA AB
VAXJO,  SW.
Contract Manufacturer;  
ARCOMA AB
VAXJO,  SW.
ARCOS S.P.A
TRAVAGLIATATO (BS),  IT.
Unregistered Foreign Lister;  
ARCOS S.P.A
TRAVAGLIATATO (BS),  IT.
ARCOTOYS, INC.
KOWLOON,  HK.
Manufacturer;  
ARCOTOYS, INC.
KOWLOON,  HK.
ARCTURUS BIOSCIENCE, INC.
MOUNTAIN VIEW,  CA,  US.
Manufacturer;  
ARCTURUS BIOSCIENCE, INC.
MOUNTAIN VIEW,  CA ,  US.
ARCUS MEDICAL LLC
GASTONIA,  NC,  US.
Manufacturer;  
ARCUS MEDICAL LLC
GASTONIA,  NC ,  US.
ARCWAY INDUSTRY CO., LTD.
MIAOLI,  TW.
Unregistered Foreign Lister;  
ARCWAY INDUSTRY CO., LTD.
MIAOLI,  TW.
ARDEN LABORATORIES, INCORPORATED
WILLERNIE,  MN,  US.
Manufacturer;  
ARDEN LABORATORIES, INCORPORATED
WILLERNIE,  MN ,  US.
ARDEN MEDICAL LTD.
ALCESTER, WARKS,  UK.
Manufacturer;  
ARDEN MEDICAL LTD.
ALGESTER, WARKS,  UK.
ARDENT INTL., INC.
OSSINING,  NY,  US.
Initial Importer;   Manufacturer;  
ARDENT INTL., INC.
OSSINING,  NY ,  US.
ARDENT SOUND, INC.
MESA,  AZ,  US.
Manufacturer;   Specification Developer;  
ARDENT SOUND, INC.
MESA,  AZ ,  US.
ARDET, SRL
BUCCINASCO (MILANO),  IT.
Manufacturer;  
ARDET, SRL
BUCCINASCO (MILANO),  IT.
ARDEX INTL./US, INC.
HACKENSACK,  NJ,  US.
Initial Importer;  
ARDEX INTL./US, INC.
VANCOUVER,  CA.
ARDIEM MEDICAL INC.
INDIANA,  PA,  US.
Contract Manufacturer;  
ARDIEM MEDICAL INC.
INDIANA,  PA ,  US.
ARDUS MEDICAL, INC.
CINCINNATI,  OH,  US.
Initial Importer;  
ARDUS MEDICAL, INC.
CINCINNATI,  OH ,  US.
AREA S.R.L.
PAVIA DI UDINE (UDINE),  IT.
Manufacturer;  
AREA S.R.L.
PAVIA DI UDINE (UDINE),  IT.
AREEDA ASSOC., LTD.
LOS ANGELES,  CA,  US.
Manufacturer;  
AREEDA ASSOC., LTD.
LOS ANGELES,  CA ,  US.
ARENA EYEWEAR LTD.
NEWPORT, SHROPSHIRE,  UK.
Manufacturer;  
ARENA EYEWEAR LTD.
NEWPORT, SHROPSHIRE,  UK.
ARES S.R.L.
SELVAZZANO D. (PD),  IT.
Manufacturer;  
ARES S.R.L.
SELVAZZANO D. (PD),  IT.
AREYOUPREGNANT.COM
KILGORE,  TX,  US.
Initial Importer;   Repackager/Relabeller;  
AREYOUPREGNANT.COM
KILGORE,  TX ,  US.
ARGAN CO.
NORTHRIDGE,  CA,  US.
Initial Importer;  
ARGAN CO.
NORTHRIDGE,  CA ,  US.
ARGENE INT'L
UARILHES,  FR.
Manufacturer;  
ARGENE INT'L
UARILHES,  FR.
ARGENE SA
VARILHES,  FR.
Manufacturer;  
ARGENE SA
VARILHES,  FR.
ARGENFREIGHT MARKETING ENT., INC.
MIAMI,  FL,  US.
Initial Importer;  
ARGENFREIGHT MARKETING ENT., INC.
MIAMI,  FL ,  US.
ARGENT OPTICAL MFY. LTD.
LONG GANG AREA, SHENZHEN,  CH.
Manufacturer;  
ARGENT OPTICAL MFY. LTD.
LONG GANG AREA, SHENZHEN,  CH.
ARGENTIS BIOMEDICAL LLC
KINGWOOD,  TX,  US.
Initial Importer;   Specification Developer;  
ARGENTIS BIOMEDICAL LLC
KINGWOOD,  TX ,  US.
ARGENTUM MEDICAL LLC
ASHEVILLE,  NC,  US.
Manufacturer;  
ARGENTUM MEDICAL LLC
CHICAGO,  IL ,  US.
ARGENTUM MEDICAL, LLC
WILLOWBROOK,  IL,  US.
Initial Importer;  
ARGENTUM MEDICAL, LLC
WILLOWBROOK,  IL ,  US.
ARGOMEDICAL AG
CHAM,  SZ.
Manufacturer;  
ARGOMEDICAL AG
CHAM ZUG,  SZ.
ARGOMEDICAL USA, INC.
VISTA,  CA,  US.
Initial Importer;  
ARGOMEDICAL AG
CHAM ZUG,  SZ.
ARGON MEDICAL DEVICES INC.
ATHENS,  TX,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ARGON MEDICAL DEVICES, INC
ATHENS,  TX ,  US.
ARGOS S.A.
SANTIAGO,  CI.
Manufacturer;  
ARGOS S.A.
SANTIAGO,  CI.
ARGOSY INTERNATIONAL INC.
NEW YORK,  NY,  US.
Initial Importer;  
ARGOSY INTERNATIONAL INC.
NEW YORK,  NY ,  US.
ARGUS VISION INTL. LTD.
TAINAN,  TW.
Manufacturer;  
ARGUS VISION INTL. LTD.
TAINAN,  TW.
ARI
ORCHARD HILL,  GA,  US.
Manufacturer;  
DIXON INVESTMENTS, INC.
ORCHARD HILL,  GA ,  US.
ARIAS INTERNATIONAL COMPANY, INC.
WESTON,  FL,  US.
Initial Importer;  
ARIAS INTERNATIONAL COMPANY, INC.
WESTON,  FL ,  US.
ARIBEX, INC.
OREM,  UT,  US.
Manufacturer;  
ARIBEX, INC.
OREM,  UT ,  US.
ARIEL INTERNATIONAL TRADING CO., LLC.
COLUMBIA,  MD,  US.
Initial Importer;  
ARIEL INTERNATIONAL TRADING CO., LLC.
COLUMBIA,  MD ,  US.

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Last Modified: 29 April 2006
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