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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
OSSACUR AG
BADEN WUERTTEMBERG,  GM.
Manufacturer;  
OSSACUR AG
BADEN WUERTTEMBERG,  GM.
OSSEO SCIENTIFIC, LLC
TOMS RIVER,  NJ,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
OSSEO SCIENTIFIC, LLC
TOMS RIVER,  NJ ,  US.
OSSEOUS TECHNOLOGIES OF AMERICA, INC.
NEWPORT BEACH,  CA,  US.
Initial Importer;  
OSSEOUS TECHNOLOGIES OF AMERICA, INC.
NEWPORT BEACH,  CA ,  US.
OSSEUS, LLC
OVIEDO,  FL,  US.
Initial Importer;   Specification Developer;  
OSSEUS, LLC
OVIEDO,  FL ,  US.
OSSTEM CO., LTD.
BUSAN CITY,  KS.
Manufacturer;  
OSSTEM CO., LTD.
BUSAN CITY,  KS.
OSSUR ENGINEERING, INC.
ALBION,  MI,  US.
Manufacturer;  
OSSUR H/F
110 REYKJAVIK,  IC.
OSSUR H/F
REYKJAVIK,  IC.
Manufacturer;   Specification Developer;  
OSSUR H/F
110 REYKJAVIK,  IC.
OSSUR NORDIC AB
UPPSALA,  SW.
Manufacturer;   Specification Developer;  
OSSUR H/F
110 REYKJAVIK,  IC.
OSSUR NORTH AMERICA, INC.
ALISO VIEJO,  CA,  US.
Initial Importer;   Manufacturer;  
OSSUR H/F
110 REYKJAVIK,  IC.
OST MEDICAL INC.
WARWICK,  RI,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;  
OST MEDICAL INC.
WARWICK,  RI ,  US.
OSTAR MEDITECH CORP.
TAIPEI HSIEN,  TW.
Manufacturer;  
OSTAR MEDITECH CORP.
TAIPEI HSIEN,  TW.
OSTEO CRISTAL
SOUTH EL MONTE,  CA,  US.
Initial Importer;  
OSTEO CRISTAL
SOUTH EL MONTE,  CA ,  US.
OSTEO IMPLANT CORP.
NEW CASTLE,  PA,  US.
Specification Developer;  
OSTEO IMPLANT CORP.
NEW CASTLE,  PA ,  US.
OSTEO WEST SURGICAL CORP.
SAN DIEGO,  CA,  US.
Initial Importer;  
OSTEO WEST SURGICAL CORP.
SAN DIEGO,  CA ,  US.
OSTEOBIOLOGICS, INC.
SAN ANTONIO,  TX,  US.
Manufacturer;  
OSTEOBIOLOGICS, INC.
SAN ANTONIO,  TX ,  US.
OSTEOGENICS BIOMEDICAL, INC.
LUBBOCK,  TX,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
OSTEOGENICS BIOMEDICAL, INC.
LUBBOCK,  TX ,  US.
OSTEOGENICS, INC.
BURLINGTON,  WI,  US.
Specification Developer;  
OSTEOGENICS, INC.
BURLINGTON,  WI ,  US.
OSTEOMED L.P.
ADDISON,  TX,  US.
Manufacturer;   Specification Developer;  
OSTEOMED L.P.
ADDISON,  TX ,  US.
OSTEOMEDICS, INC.
PARAMUS,  NJ,  US.
Initial Importer;  
OSTEOMEDICS, INC.
PARAMUS,  NJ ,  US.
OSTEOMEDICS, INC.
PARKRIDGE,  NJ,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OSTEOMEDICS, INC.
PARAMUS,  NJ ,  US.
OSTEOMETER MEDITECH, INC.
HAWTHORNE,  CA,  US.
Manufacturer;  
OSTEOMETER MEDITECH, INC.
HAWTHORNE,  CA ,  US.
OSTEOSYNTEC, INC.
LAKE FOREST,  IL,  US.
Initial Importer;  
OSTEOSYNTEC, INC.
LAKE FOREST,  IL ,  US.
OSTEOTECH, INC.
EATONTOWN,  NJ,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
OSTEOTECH, INC.
EATONTOWN,  NJ ,  US.
OSTER NY INC.
MONSEY,  NY,  US.
Initial Importer;  
OSTER NY INC.
MONSEY,  NY ,  US.
OSTERGAARD ENT.
FRESNO,  CA,  US.
Manufacturer;  
OSTERGAARD ENT.
FRESNO,  CA ,  US.
OSUNG INDUSTRIAL CO.
KYONGGI-DO,  KS.
Manufacturer;  
OSUNG INDUSTRIAL CO.
KYONGGI-DO,  KS.
OSYPKA MEDICAL GMBH
BERLIN,  GM.
Manufacturer;  
OSYPKA MEDICAL GMBH
BERLIN,  GM.
OSYPKA MEDICAL, INC.
LA JOLLA,  CA,  US.
Manufacturer;  
OSYPKA MEDICAL, INC.
LA JOLLA,  CA ,  US.
OTAGO CORP., SDN, BHD
IPOH, PK.,  MY.
Manufacturer;  
OTAGO CORP., SDN, BHD
IPOH, PK.,  MY.
OTC OPTICS DBA EYEMAGINE
LAKE BLUFF,  IL,  US.
Initial Importer;  
OTC OPTICS DBA EYEMAGINE
LAKE BLUFF,  IL ,  US.
OTEGO OPTICAL, INC.
HARTWICK,  NY,  US.
Initial Importer;  
OTEGO OPTICAL, INC.
HARTWICK,  NY ,  US.
OTICON A/S
THISTED,  DA.
Unregistered Foreign Lister;  
WILLIAM DEMANT HOLDINGS, A/S
SMORUM,  DA.
OTICON, INC.
SOMERSET,  NJ,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
WILLIAM DEMANT HOLDINGS, A/S
SMORUM,  DA.
OTIS BIOTECH CO., LTD
SIHUNG CITY, KYONGGI-DO,  KS.
Manufacturer;  
OTIS BIOTECH CO., LTD
SIHUNG CITY, KYONGGI-DO,  KS.
OTO PRODUCTS, INC.
CHATSWORTH,  CA,  US.
Initial Importer;  
OTO PRODUCTS, INC.
CHATSWORTH,  CA ,  US.
OTODYNAMICS, LTD.
HATFIELD, HERTS,  UK.
Manufacturer;  
OTODYNAMICS, LTD.
HATFIELD, HERTS,  UK.
OTO-MED TECHNOLOGIES, INC.
CASSELBERRY,  FL,  US.
Specification Developer;   Repackager/Relabeller;  
OTO-MED TECHNOLOGIES, INC.
CASSELBERRY,  FL ,  US.
OTO-MED, INC.
LAKE HAVASU CITY,  AZ,  US.
Manufacturer;  
OTO-MED, INC.
LAKE HAVASU CITY,  AZ ,  US.
OTOTECH, LLC
BRISTOL,  PA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
OTOTECH, LLC
BRISTOL,  PA ,  US.
OTOVATION, LLC
LEDERACH,  PA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
SENSORY ARTS & SCIENCE, LLC
KING OF PRUSSIA,  PA ,  US.

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Last Modified: 29 April 2006
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