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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
AVR COMMUNICATIONS LTD.
MIGDAL HAEMEK,  IS.
Manufacturer;   Specification Developer;  
AVR COMMUNICATIONS LTD.
MIGDAL HAEMEK,  IS.
AVREO, INC.
NEW ORLEANS,  LA,  US.
Manufacturer;  
AVREO, INC.
NEW ORLEANS,  LA ,  US.
AVRY'S ORTHOTIC FACILITY, INC.
YOUNGSTOWN,  OH,  US.
Manufacturer;  
AVRY'S ORTHOTIC FACILITY, INC.
YOUNGSTOWN,  OH ,  US.
AWARD SOLUTIONS, INC.
RALEIGH,  NC,  US.
Initial Importer;  
AWARD SOLUTIONS, INC.
RALEIGH,  NC ,  US.
AWARENESS TECHNOLOGY, INC.
PALM CITY,  FL,  US.
Contract Manufacturer;   Manufacturer;  
AWARENESS TECHNOLOGY, INC.
PALM CITY,  FL ,  US.
AWHEALTH PTY LTD.
STEPNEY SA,  AS.
Unregistered Foreign Lister;  
AWHEALTH PTY LTD.
STEPNEY SA,  AS.
AXCAN SCANDIPHARM, INC.
BIRMINGHAM,  AL,  US.
Initial Importer;   Specification Developer;  
AXCAN SCANDIPHARM, INC.
BIRMINGHAM,  AL ,  US.
AXCEN PHOTONICS CORP.
SHINDIAN CITY, TAIPEI HSIEN,  TW.
Manufacturer;  
AXCEN PHOTONICS CORP.
SHINDIAN CITY, TAIPEI HSIEN,  TW.
AXCESOR, INC.
GRAFTON,  WI,  US.
Contract Manufacturer;  
AXCESOR, INC.
GRAFTON,  WI ,  US.
AXE CO., LTD.
OSAKA-CITY, OSAKA,  JA.
Manufacturer;  
AXE CO., LTD.
OSAKA-CITY, OSAKA,  JA.
AXEBO
ST. LAURENT,  FR.
Manufacturer;  
AXEBO
ST. LAURENT,  FR.
AXEL BIO CORPORATION
SAN DIEGO,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
AXEL BIO CORPORATION
SAN DIEGO,  CA ,  US.
AXEL S. MODEBRILLEN DESIGN & PRODUCTION GMBH
LOEFFINGEN,  GM.
Manufacturer;  
AXEL S. MODEBRILLEN DESIGN & PRODUCTION GMBH
LOEFFINGEN,  GM.
AXEL TRADING CO., INC.
MAIMI,  FL,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
AXEL TRADING CO., INC.
MAIMI,  FL ,  US.
AXELGAARD MFG. CO., LTD.
FALLBROOK,  CA,  US.
Manufacturer;  
AXELGAARD MFG. CO., LTD.
FALLBROOK,  CA ,  US.
AXIA MEDICA S.A
BECCAR,  AR.
Manufacturer;  
AXIA MEDICA S.A
BECCAR,  AR.
AXIOM ENT. CO., LTD.
KAOHSIUNG,  TW.
Repackager/Relabeller;  
AXIOM ENT. CO., LTD.
KAOHSIUNG,  TW.
AXIOM INTERNATIONAL, INC.
BILLINGS,  MT,  US.
Initial Importer;  
AXIOM INTERNATIONAL, INC.
BILLINGS,  MT ,  US.
AXIOM MEDICAL, INC.
RANCHO DOMINGUEZ,  CA,  US.
Manufacturer;  
AXIOM MEDICAL, INC.
RANCHO DOMINGUEZ,  CA ,  US.
AXIOM WORLDWIDE, INC.
TAMPA,  FL,  US.
Manufacturer;  
AXIOM WORLDWIDE, INC.
TAMPA,  FL ,  US.
AXIS DENTAL CORP.
IRVING,  TX,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
AXIS DENTAL CORP.
IRVING,  TX ,  US.
AXIS INDUSTRIES, INC.
ELKHART,  IN,  US.
Manufacturer;   Specification Developer;  
AXIS INDUSTRIES, INC.
ELKHART,  IN ,  US.
AXIS-SHIELD ASA
OSLO,  NO.
Manufacturer;  
AXIS-SHIELD ASA
OSLO,  NO.
AXIS-SHIELD DIAGNOSTICS, LTD.
DUNDEE, SCOTLAND,  UK.
Contract Manufacturer;   Manufacturer;  
AXIS-SHIELD DIAGNOSTICS, LTD.
DUNDEE, SCOTLAND,  UK.
AXIS-SHIELD POC AS
OSLO,  NO.
Manufacturer;   Specification Developer;  
AXIS-SHIELD POC AS
OSLO,  NO.
AXIZ GROUP L.L.C.
SKOKIE,  IL,  US.
Initial Importer;  
AXIZ GROUP L.L.C.
SKOKIE,  IL ,  US.
AXN GROUP, LTD.
CERRITOS,  CA,  US.
Initial Importer;  
AXN GROUP, LTD.
CERRITOS,  CA ,  US.
AXON SYSTEMS, INC.
HAUPPAUGE,  NY,  US.
Manufacturer;  
AXON SYSTEMS, INC.
HAUPPAUGE,  NY ,  US.
AXONE
GIEN,  FR.
Contract Manufacturer;  
AXONE
GIEN,  FR.
AXSYS CORP.
CHADDS FORD,  PA,  US.
Manufacturer;  
AXSYS CORP.
KENNETT SQUARE,  PA ,  US.
AXYA MEDICAL, INC.
BEVERLY,  MA,  US.
Manufacturer;  
AXYA MEDICAL, INC.
BEVERLY,  MA ,  US.
AYAZ ENTERPRISE, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
AYAZ ENTERPRISE, INC.
LOS ANGELES,  CA ,  US.
AYCAN DIGITALSYSTEME GMBH
WUERZBURG,  GM.
Manufacturer;  
AYCAN DIGITALSYSTEME GMBH
WUERZBURG,  GM.
AYE OPTICS PTE LTD
SN.
Specification Developer;   Repackager/Relabeller;  
AYE OPTICS PTE LTD
SN.
AYERS HANDICAP CONVERSION CENTER
QUINCY,  MA,  US.
Initial Importer;  
AYERS HANDICAP CONVERSION CENTER
QUINCY,  MA ,  US.
AYOCO
BOCA RATON,  FL,  US.
Initial Importer;  
AYOCO
BOCA RATON,  FL ,  US.
AYRTON SRL
LENTIAI (BELLUNO),  IT.
Unregistered Foreign Lister;  
AYRTON SRL
LENTIAI (BELLUNO),  IT.
AYURVEDA USA, LLC
BROADVIEW HEIGHTS,  OH,  US.
Initial Importer;  
AYURVEDA USA, LLC
BROADVIEW HEIGHTS,  OH ,  US.
AZ INSTRUMENT (SHEN ZHEN) CO., LTD.
SHENZHEN,  CH.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BT MEDICAL INC.
TAICHUNG,  TW.
A-Z SALES INC.
MIAMI,  FL,  US.
Initial Importer;  
A-Z SALES INC.
MIAMI,  FL ,  US.

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Last Modified: 29 April 2006
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