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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
ARTERIA MEDICAL SCIENCE, INC.
SAN FRANCISCO,  CA,  US.
Specification Developer;  
ARTERIA MEDICAL SCIENCE, INC.
SAN FRANCISCO,  CA ,  US.
ARTEX INTERNATIONAL INC
HIGHLAND,  IL,  US.
Initial Importer;  
ARTEX INTERNATIONAL INC
HIGHLAND,  IL ,  US.
ARTHO AQUATIC FITNESS SYSTEM, INC.
DETROIT,  MI,  US.
Specification Developer;  
ARTHO AQUATIC FITNESS SYSTEM, INC.
DETROIT,  MI ,  US.
ARTHOCARE UK, LTD.
HARROGATE, N. YORKS,  UK.
Manufacturer;   Specification Developer;  
ARTHROCARE CORP.
SUNNYVALE,  CA ,  US.
ARTHREX CALIFORNIA, INC.
WALNUT,  CA,  US.
Manufacturer;  
ARTHREX, INC.
NAPLES,  FL ,  US.
ARTHREX, INC.
NAPLES,  FL,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Contract Sterilizer;   Repackager/Relabeller;  
ARTHREX, INC.
NAPLES,  FL ,  US.
ARTHROCARE CORP.
AURORA DE HEREDIA,  CS.
Manufacturer;  
ARTHROCARE CORP.
SUNNYVALE,  CA ,  US.
ARTHROCARE CORP.
SAN JUAN CAPISTRANO,  CA,  US.
Manufacturer;  
ARTHROCARE CORP.
SUNNYVALE,  CA ,  US.
ARTHROCARE CORP.
SANFORD,  FL,  US.
Initial Importer;  
ARTHROCARE CORP.
SUNNYVALE,  CA ,  US.
ARTHROCARE CORP.
SUNNYVALE,  CA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ARTHROCARE CORP.
SUNNYVALE,  CA ,  US.
ARTHROCARE EUROPE AB
STOCKHOLM,  SW.
Foreign Exporter;  
ARTHROCARE CORP.
SUNNYVALE,  CA ,  US.
ARTHROCARE UK LTD
GLENFIELD,  UK.
Contract Manufacturer;   Manufacturer;  
ARTHROCARE CORP.
SUNNYVALE,  CA ,  US.
ARTHRON, INC.
FRANKLIN,  TN,  US.
Initial Importer;   Specification Developer;  
ARTHRON, INC.
FRANKLIN,  TN ,  US.
ARTHRONET GMBH & CO. KG
BURSCHEID,  GM.
Specification Developer;  
ARTHRONET GMBH & CO. KG
BURSCHEID,  GM.
ARTHRONET MEDICAL, INC.
IRVINE,  CA,  US.
Initial Importer;  
ARTHRONET MEDICAL, INC.
IRVINE,  CA ,  US.
ARTHRONIX
NEW CITY,  NY,  US.
Specification Developer;  
ARTHRONIX
NEW CITY,  NY ,  US.
ARTHROPLASTICS, INC.
CHAGRIN FALLS,  OH,  US.
Manufacturer;  
ARTHROPLASTICS, INC.
CHAGRIN FALLS,  OH ,  US.
ARTHROSURFACE, INC.
FRANKLIN,  MA,  US.
Manufacturer;   Specification Developer;  
ARTHROSURFACE, INC.
FRANKLIN,  MA ,  US.
ARTHROTEK, INC.
ONTARIO,  CA,  US.
Manufacturer;  
BIOMET, INC.
WARSAW,  IN ,  US.
ARTHROTEK, INC.
REDDING,  CA,  US.
Manufacturer;  
BIOMET, INC.
WARSAW,  IN ,  US.
ARTHUR BLANK & CO., INC.
BOSTON,  MA,  US.
Contract Manufacturer;   Manufacturer;  
ARTHUR BLANK & CO., INC.
BOSTON,  MA ,  US.
ARTHUR HALL ORTHODONTICS [NZ] LTD.
MOERAKI, NORTH OTAGO,  NZ.
Manufacturer;  
ARTHUR HALL ORTHODONTICS [NZ] LTD.
MOERAKI, NORTH OTAGO,  NZ.
ARTHUR SHUSTER, INC.
SAINT PAUL,  MN,  US.
Initial Importer;  
ARTHUR SHUSTER, INC.
SAINT PAUL,  MN ,  US.
ARTHUR'S IMPEX, INC.
FLUSHING,  NY,  US.
Initial Importer;  
ARTHUR'S IMPORT & EXPORT CO.
FRESH MEADOW,  NY ,  US.
ARTICULOS HIGIENICOS
IZCALLI EDO DE,  MX.
Unregistered Foreign Lister;  
ARTICULOS HIGIENICOS
IZCALLI EDO DE,  MX.
ARTICULOS HIGIENICOS S.A. DE C.V.
CUAUTITLAN IZCALLI, EDO DE,  MX.
Manufacturer;  
ARTICULOS HIGIENICOS S.A. DE C.V.
CUAUTITLAN IZCALLI, EDO DE,  MX.
ARTIDE, INC.
NEW YORK,  NY,  US.
Initial Importer;  
ARTIDE, INC.
NEW YORK,  NY ,  US.
ARTIFICIAL AIRWAY TECHNOLOGY
MEMPHIS,  TN,  US.
Specification Developer;  
ARTIFICIAL AIRWAY TECHNOLOGY
MEMPHIS,  TN ,  US.
ARTIFICIAL MEDICAL SUPPLIES, INC.
WILSON,  NC,  US.

ARTIFICIAL MEDICAL SUPPLIES, INC.
WILSON,  NC ,  US.
ARTIMPLANT AB
V. FROLUNDA,  SW.
Manufacturer;  
ARTIMPLANT AB
V. FROLUNDA,  SW.
ARTIS ELECTRONIC TECHNOLOGIES CO., LTD.
SHENZHEN CITY,  CH.
Manufacturer;  
YAS HEALTHY FITNESS CO., LTD.
TAOYUAN CITY,  TW.
ARTISAN MEDICAL DEVICES
SUNNYVALE,  CA,  US.
Specification Developer;  
ARTISAN MEDICAL DEVICES
SUNNYVALE,  CA ,  US.
ARTISAN OF CANADA(DIVISION OF BDARK HOLDINGS LTD.)
EDMONTON, AB,  CA.
Foreign Exporter;  
ARTISAN OF CANADA(DIVISION OF BDARK HOLDINGS LTD.)
EDMONTON, AB,  CA.
ARTOPTIC INTL. CORP.
NEW YORK,  NY,  US.
Initial Importer;  
ARTOPTIC INTL. CORP.
NEW YORK,  NY ,  US.
ARTREAL MANUFACTORY (HUIYANG), LTD.
HUIZHOU CITY, GUANGDONG,  CH.
Contract Manufacturer;  
ARTREAL MANUFACTORY (HUIYANG), LTD.
HUIZHOU CITY, GUANGDONG,  CH.
ARTRONICS
EASLEY,  SC,  US.
Manufacturer;  
ARTRONICS
EASLEY,  SC ,  US.
ART'S DENTAL SUPPLY
PUERTO NUEVO,  PR,  US.
Initial Importer;  
ART'S DENTAL SUPPLY
PUERTO NUEVO,  PR ,  US.
ARTS OPTICAL COMPANY LIMITED
KWUN TONG, KOWLOON,  HK.
Manufacturer;  
ARTS OPTICAL COMPANY LIMITED
KWUN TONG, KOWLOON,  HK.
ARTSANA S.P.A.
COMO,  IT.
Manufacturer;  
ARTSANA S.P.A.
COMO,  IT.
ARTSCAN OY
HELSINKI,  FI.
Manufacturer;  
ARTSCAN OY
HELSINKI,  FI.

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Last Modified: 29 April 2006
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