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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
ANTI AGING SOLUTIONS INC.
TORONTO, ONTARIO,  CA.
Foreign Exporter;   Repackager/Relabeller;  
ANTI AGING SOLUTIONS INC.
TORONTO, ONTARIO,  CA.
AN-TI DESIGN LTD.
SAN PO KONG,  HK.
Manufacturer;  
AN-TI DESIGN LTD.
SAN PO KONG,  HK.
ANTIBODIES INC.
DAVIS,  CA,  US.
Manufacturer;  
ANTIBODIES INC.
DAVIS,  CA ,  US.
ANTIQUITA SRL
UDINE,  IT.
Unregistered Foreign Lister;  
ANTIQUITA SRL
UDINE,  IT.
ANTJE TONTARRA
WURMLINGEN,  GM.
Repackager/Relabeller;  
ANTJE TONTARRA
WURMLINGEN,  GM.
ANTON BETZLER GMBH
TUTTLINGEN-NENDINGEN,  GM.
Manufacturer;  
ANTON BETZLER GMBH
TUTTLINGEN-NENDINGEN,  GM.
ANTON HIPP GMBH
FRIDINGEN,  GM.
Manufacturer;  
ANTON HIPP GMBH
FRIDINGEN,  GM.
ANTON MEYER & CO. LTD.
BIEL,  SZ.
Manufacturer;  
ANTON MEYER & CO. LTD.
BIEL,  SZ.
ANTON ZAHORANSKY GMBH & CO.
TODTNAU, BADEN-WUERTENBERG,  GM.
Contract Manufacturer;  
ANTON ZAHORANSKY GMBH & CO.
TODTNAU, BADEN-WUERTENBERG,  GM.
ANTONI CARLES, S.A.
VILASSAR DE MAR (BARCELONA),  SP.
Manufacturer;  
ANTONI CARLES BOSCH
VILASSAR DE MAR (BARCELONA),  SP.
ANTRACO, INC.
MORRISTOWN,  NJ,  US.
Initial Importer;  
ANTRACO, INC.
MORRISTOWN,  NJ ,  US.
ANTYLLOS MEDIZINTECHNIK GMBH
TUTTLINGEN,  GM.
Repackager/Relabeller;  
ANTYLLOS MEDIZINTECHNIK GMBH
TUTTLINGEN,  GM.
ANULEX TECHNOLOGIES, INC
MINNETONKA,  MN,  US.
Manufacturer;   Specification Developer;  
ANULEX TECHNOLOGIES, INC
MINNETONKA,  MN ,  US.
ANUP CHAKRABORTY CO.
LINCOLN,  NE,  US.
Specification Developer;  
ANUP CHAKRABORTY CO.
LINCOLN,  NE ,  US.
ANWAR BRUSH CO.
DHAKA,  BG.
Manufacturer;  
ANWAR BRUSH CO.
DHAKA,  BG.
ANYBATTERY, INC
ROSEMOUNT,  MN,  US.
Repackager/Relabeller;  
ANYBATTERY, INC
ROSEMOUNT,  MN ,  US.
ANZACARE LTD.
NELSON,  NZ.
Manufacturer;  
ANZACARE LTD.
NELSON,  NZ.
ANZAI MEDICAL CO, LTD.
TOKYO,  JA.
Manufacturer;  
ANZAI MEDICAL CO, LTD.
TOKYO,  JA.
ANZON CO., INC.
EL MONTE,  CA,  US.
Contract Manufacturer;  
ANZON CO., INC.
EL MONTE,  CA ,  US.
AO EYEWEAR, INC.
SOUTHBRIDGE,  MA,  US.
Initial Importer;   Manufacturer;  
AO EYEWEAR, INC.
SOUTHBRIDGE,  MA ,  US.
AO QUEST EUROPE
FOUGERES CEDEX,  FR.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
AOB BIOTECH, INC.
SEATTLE,  WA,  US.
Repackager/Relabeller;  
AOB BIOTECH, INC.
SEATTLE,  WA ,  US.
AOD DENTAL CLINICS
MIAMI,  FL,  US.
Initial Importer;  
AOD DENTAL CLINICS
MIAMI,  FL ,  US.
AOL INTERNATIONAL PTY, LTD.
KIRRANEE NSW,  AS.
Unregistered Foreign Lister;  
AOL INTERNATIONAL PTY, LTD.
KIRRANEE NSW,  AS.
AOLTEC INTERNATIONAL, INC.
ONTARIO,  CA,  US.
Initial Importer;  
AOLTEC INTERNATIONAL, INC.
ONTARIO,  CA ,  US.
AOMORI OLYMPUS CO., LTD.
KUROISHI-SHI, AOMORI-KEN,  JA.
Foreign Exporter;   Manufacturer;  
OLYMPUS MEDICAL SYSTEMS CORPORATION
HACHIOJI-SHI, TOKYO,  JA.
A-ONE SCISSOR CO.
SIALKOT-4,  PK.
Manufacturer;  
A-ONE SCISSOR CO.
SIALKOT-4,  PK.
A-ONE TOOLS, INC.
KISSIMMEE,  FL,  US.
Initial Importer;  
A-ONE TOOLS, INC.
KISSIMMEE,  FL ,  US.
AOOT "ZAVOD KOMPONENT"
MOSCOW,  RS.
Unregistered Foreign Lister;  
AOOT "ZAVOD KOMPONENT"
MOSCOW,  RS.
AORTECH CRITICAL CARE LTD.
BELLSHILL, LANARKSHIRE,  UK.
Manufacturer;  
AORTECH CRITICAL CARE LTD.
BELLSHILL, LANARKSHIRE,  UK.
AO-SOLA
HEBRON,  KY,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
AO-SOLA
SAN DIEGO,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
AOSS MEDICAL SUPPLY, INC.
MONROE,  LA,  US.
Manufacturer;  
AOSS MEDICAL SUPPLY, INC.
MONROE,  LA ,  US.
AOYAMA OPTICAL CO., LTD.
SABAE-CITY, FUKUI-PREF.,  JA.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AOYAMA OPTICAL CO., LTD.
SABAE-CITY, FUKUI-PREF.,  JA.
AOYAMA OPTICAL USA INC.
RONKONKOMA,  NY,  US.
Initial Importer;  
AOYAMA OPTICAL USA INC.
RONKONKOMA,  NY ,  US.
AP TECHNOLOGIES SA
LA BRASSUS,  SZ.
Contract Manufacturer;  
AP TECHNOLOGIES SA
LA BRASSUS,  SZ.
APA MEDICAL EQUIPMENT CO., INC.
MINNEAPOLIS,  MN,  US.
Initial Importer;  
APA MEDICAL EQUIPMENT CO., INC.
MINNEAPOLIS,  MN ,  US.
APARAT MEDICAL SALES CO.
SAN CLEMENTE,  CA,  US.

APARAT MEDICAL SALES CO.
SAN CLEMENTE,  CA ,  US.
APATECH INC.
FOXBOROUGH,  MA,  US.
Initial Importer;  
APATECH LTD.
LONDON,  UK.
APATECH LTD.
LONDON,  UK.
Manufacturer;  
APATECH LTD.
LONDON,  UK.

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Last Modified: 29 April 2006
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