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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
OTS CORP.
WEAVERVILLE,  NC,  US.
Manufacturer;  
OTS CORP.
WEAVERVILLE,  NC ,  US.
OTSUKA ELECTRONICS CO., LTD.
OSAKA,  JA.
Manufacturer;  
OTSUKA PHARMACEUTICAL CO., LTD.
TOKYO,  JA.
OTTAWA DENTAL LABORATORY, LTD
OTTAWA,  IL,  US.
Manufacturer;  
OTTAWA DENTAL LABORATORY, LTD
OTTAWA,  IL ,  US.
OTTER (CHINA) TECHNOLOGY CO., LTD.
WUXI, JIANGSU,  CH.
Foreign Exporter;   Manufacturer;  
OTTER (CHINA) TECHNOLOGY CO., LTD.
WUXI, JIANGSU,  CH.
OTTICA GECELE SNC
TRENTO,  IT.
Unregistered Foreign Lister;  
OTTICA GECELE SNC
TRENTO,  IT.
OTTICA MELONI SRL
ROMA,  IT.
Repackager/Relabeller;  
OTTICA MELONI SRL
ROMA,  IT.
OTTICA PREALPI SRL
VALDOBBIADENE, TREVISO, TV,  IT.
Manufacturer;  
OTTICA PREALPI SRL
VALDOBBIADENE, TREVISO, TV,  IT.
OTTO BOCK AUSTRALIA/ASIA PTY.
BAULKHAM HILLS, NSN,  AS.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK AUSTRIA
VIENNA,  AU.
Manufacturer;   Specification Developer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK CHINA
CHAOYANG DISTRICT, BEIJING,  CH.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK FRANCE
LES ULIS CEDEX,  FR.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK HEALTH CARE
OAKVILLE,ONTARIO,  CA.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK HEALTH CARE, LP
MINNEAPOLIS,  MN,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK HEALTHCARE
MINNEAPOLIS,  MN,  US.
Initial Importer;  
OTTO BOCK HEALTHCARE
MINNEAPOLIS,  MN ,  US.
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK HEALTHCARE, GMBH
KONIGSEE,  GM.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK HEALTHCARE, LP
WINTER PARK,  FL,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK ITALIA SRL
BUDRIO,  IT.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK RAMSBACH-BAUMBACH
RAMSBACH-BAUMBACH,  GM.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK SCANDINAVIA AB
NORRKOPING,  SW.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK SINSHEIM
SINSHEIM,  GM.
Manufacturer;   Specification Developer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK TECHNICAL CENTER
CENTERVILLE,  OH,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO BOCK TECHNICAL CENTER
MINNEAPOLIS,  MN,  US.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
OTTO FANKHANEL & SOHN, A SUBS. OF TYCO INTL., LTD.
BAMBERG 1,  GM.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
TYCO HEALTHCARE GROUP, LP
MANSFIELD,  MA ,  US.
OTTO LEIBINGER GMBH
MUHLHEIM,  GM.
Manufacturer;  
OTTO LEIBINGER GMBH
MUHLHEIM,  GM.
OTTO RUDOLF
FRIDINGEN,  GM.
Manufacturer;  
OTTO RUDOLF
FRIDINGEN,  GM.
OTTO RUTTGERS GMBH CO. KG
SOLINGEN,  GM.
Manufacturer;  
OTTO RUTTGERS GMBH CO. KG
SOLINGEN,  GM.
OTTO SCHMID OHG
TUTTLINGEN,  GM.
Contract Manufacturer;   Manufacturer;  
OTTO SCHMID OHG
TUTTLINGEN,  GM.
OTTOBOCK HEALTHCARE
SALT LAKE CITY,  UT,  US.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
O-TWO MEDICAL TECHNOLOGIES, INC.
MISSISSAUGA, ONTARIO,  CA.
Manufacturer;  
O-TWO MEDICAL TECHNOLOGIES, INC.
MISSISSAUGA, ONTARIO,  CA.
OUHAI TONGDA GLASSES FACTORY
WENZHOU,  CH.
Manufacturer;  
OUHAI TONGDA GLASSES FACTORY
WENZHOU,  CH.
OUR WAY CORP.
TAICHUNG, TAIWAN,  CH.
Manufacturer;  
OUR WAY CORP.
TAICHUNG, TAIWAN,  CH.
OURPLANET SOLUTIONS, LLC
PASADENA,  MD,  US.
Initial Importer;  
OURPLANET SOLUTIONS, LLC
PASADENA,  MD ,  US.
OUT SOURCE MFG, LLC.
WARSAW,  IN,  US.
Contract Manufacturer;  
OUT SOURCE MFG, LLC.
WARSAW,  IN ,  US.
OUTDOOR ACTION WEAR SPECIALTIES
BRAZIL,  IN,  US.
Initial Importer;  
SOLAR BAT ENT., INC.
BRAZIL,  IN ,  US.
OUTDOOR DESIGN, INC.
BENTONVILLE,  AR,  US.
Initial Importer;  
OUTDOOR DESIGN, INC.
BENTONVILLE,  AR ,  US.
OUTDOOR SPORTS OPTICS
CHICAGO,  IL,  US.
Initial Importer;   Repackager/Relabeller;  
OUTDOOR SPORTS OPTICS
CHICAGO,  IL ,  US.
OUTFIT CONDOMS INC.
ST. PAUL,  MN,  US.
Initial Importer;  
OUTFIT CONDOMS INC.
ST. PAUL,  MN ,  US.
OUTLOOK GRAPHICS CORP.
NEENAH,  WI,  US.
Repackager/Relabeller;  
OUTLOOK GROUP CORP.
NEENAH,  WI ,  US.
OUTSOURCE MANUFACTURING, INC.
CARLSBAD,  CA,  US.
Contract Manufacturer;  
OUTSOURCE MANUFACTURING, INC.
CARLSBAD,  CA ,  US.

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Last Modified: 29 April 2006
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