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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
OCUSERV INSTRUMENTS, INC.
JAMAICA,  NY,  US.
Manufacturer;  
OCUSERV INSTRUMENTS, INC.
JAMAICA,  NY ,  US.
OCUSOFT, INC.
ROSENBERG,  TX,  US.
Initial Importer;   Repackager/Relabeller;  
OCUSOFT, INC.
ROSENBERG,  TX ,  US.
ODEUM MARKETING, INC.
WILMINGTON,  DE,  US.
Initial Importer;  
ODEUM MARKETING, INC.
WILMINGTON,  DE ,  US.
ODIN MEDICAL TECHNOLOGIES LTD.
YOKNEAM ELIT,  IS.
Manufacturer;  
ODIN MEDICAL TECHNOLOGIES LTD.
YOKNEAM ELIT,  IS.
ODLM S.A.
CHAMPANGE AU MONT D'OR, RHONE,  FR.
Foreign Exporter;  
ODLM S.A.
CHAMPANGE AU MONT D'OR, RHONE,  FR.
ODO S.A.
MORBIER,  FR.
Manufacturer;  
ODO S.A.
MORBIER,  FR.
ODON LIFETECHNOLOGY
MARLY LE ROI,  FR.
Manufacturer;  
DURAND J.P.
AUNEY/ODON,  FR.
ODONTIT SA
BUENOS AIRES,  AR.
Contract Manufacturer;   Specification Developer;  
ODONTIT SA
BUENOS AIRES,  AR.
ODONTO CORP.
MORRISBURG,ONTARIO,  CA.
Unregistered Foreign Lister;  
ODONTO CORP.
MORRISBURG,ONTARIO,  CA.
ODONTO CORP.
HALLANDALE,  FL,  US.
Initial Importer;  
ODONTO CORP.
HALLANDALE,  FL ,  US.
ODONTO-WAVE
FORT COLLINS,  CO,  US.
Initial Importer;  
XO CARE A/S
HORSHOLM,  DA.
ODS GMBH
KISDORF SCHL.-HOLST.,  GM.
Repackager/Relabeller;  
ODS GMBH
KISDORF SCHL.-HOLST.,  GM.
ODYSSEY EYEWEAR PTY LTD
NORTH FREMANTLE,  AS.
Foreign Exporter;  
ODYSSEY EYEWEAR PTY LTD
NORTH FREMANTLE,  AS.
ODYSSEY MEDICAL, INC.
MEMPHIS,  TN,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ODYSSEY MEDICAL, INC.
MEMPHIS,  TN ,  US.
ODYSSEY PHARMACEUTICALS, INC.
EAST HANOVER,  NJ,  US.
Initial Importer;  
ODYSSEY PHARMACEUTICALS, INC.
EAST HANOVER,  NJ ,  US.
ODYSSEY USA, INC.
SAN CLEMENTE,  CA,  US.
Initial Importer;  
ODYSSEY EYEWEAR PTY LTD
NORTH FREMANTLE,  AS.
OEM INCORPORATED
SCOTTSDALE,  AZ,  US.
Manufacturer;  
OEM INCORPORATED
SCOTTSDALE,  AZ ,  US.
OEM SYSTEMS CO. LTD.
UJI-SHI,  JA.
Unregistered Foreign Lister;  
OEM SYSTEMS CO. LTD.
UJI-SHI,  JA.
OEM SYSTEMS CO. LTD.
UJI-SHI KYOTO,  JA.
Contract Manufacturer;  
OEM SYSTEMS CO. LTD.
UJI-SHI KYOTO,  JA.
OEM WORLDWIDE LLC
WATERTOWN,  SD,  US.
Contract Manufacturer;  
EVERETT SMITH GROUP, LTD.
MILWAUKEE,  WI ,  US.
OERTEL + LEHNER GMBH
STUTTGART,  GM.
Manufacturer;  
OERTEL + LEHNER GMBH
STUTTGART,  GM.
OERTEL MEDIZINTECHNIK
TUTTLINGEN,  GM.
Contract Manufacturer;   Manufacturer;  
OERTEL MEDIZINTECHNIK
TUTTLINGEN,  GM.
OERTLI INSTRUMENTE AG
BERNECK,  SZ.
Manufacturer;  
OERTLI INSTRUMENTE AG
BERNECK,  SZ.
OESTERREICHISCHE PHILIPS INDUSTRIE GMBH, ZWEIGNIED
KLAGENFURT,  AU.
Unregistered Foreign Lister;  
OESTERREICHISCHE PHILIPS INDUSTRIE GMBH, ZWEIGNIED
KLAGENFURT,  AU.
OETTLING MEDIZINTECHNIK
TUTTLINGEN,  GM.
Manufacturer;  
OETTLING MEDIZINTECHNIK
TUTTLINGEN,  GM.
OFF THE RUNWAY INC.
MIAMI BEACH,  FL,  US.
Initial Importer;  
OFF THE RUNWAY INC.
MIAMI BEACH,  FL ,  US.
OFFICE FOR INTL. SERVICES, INC.
LAS VEGAS,  NV,  US.
Initial Importer;  
OFFICE FOR INTL. SERVICES, INC.
LAS VEGAS,  NV ,  US.
OFFICINA DI PROTESI TRENTO S.P.A.
CALLIANO (TN),  IT.
Unregistered Foreign Lister;  
OFFICINA DI PROTESI TRENTO S.P.A.
CALLIANO (TN),  IT.
OFFICINA PRODOTTI ORTOPEDICI S.R.L.
BOLOGNA,  IT.
Unregistered Foreign Lister;  
OFFICINA PRODOTTI ORTOPEDICI S.R.L.
BOLOGNA,  IT.
OFS FITEL SPECIALTY PHOTONICS DIVISION
AVON,  CT,  US.
Contract Manufacturer;  
OFS FITEL LLC
NORCROSS,  GA ,  US.
OFT, INC.
PARAMOUNT,  CA,  US.
Initial Importer;  
OFT, INC.
PARAMOUNT,  CA ,  US.
OGENIX CORPORATION
CLEVELAND,  OH,  US.
Specification Developer;  
OGENIX CORPORATION
CLEVELAND,  OH ,  US.
OGO INTERNATIONAL TRADING CORP.
VERNON,  CA,  US.
Initial Importer;  
OGO INTERNATIONAL TRADING CORP.
VERNON,  CA ,  US.
OHANA NEEDLE COMPANY, INC.
LAWRENCE,  MA,  US.
Specification Developer;  
OHANA NEEDLE COMPANY, INC.
HAIKU,  HI ,  US.
OHARE MARKETING INTL. CORP.
MARIETTA,  GA,  US.
Initial Importer;   Specification Developer;  
OHARE MARKETING INTL. CORP.
MARIETTA,  GA ,  US.
OHIO MEDICAL CORPORATION
GURNEE,  IL,  US.
Manufacturer;  
OHIO MEDICAL CORPORATION
GURNEE,  IL ,  US.
OHIO REHABILITATION TECHNOLOGY CENTER (RETEC)
COLUMBUS,  OH,  US.
Initial Importer;  
OHIO REHABILITATION TECHNOLOGY CENTER (RETEC)
COLUMBUS,  OH ,  US.
OHKAWA DENTAL CLINIC
OTACITY, GUNMA PREF.,  JA.
Manufacturer;  
OHKAWA DENTAL CLINIC
OTACITY, GUNMA PREF.,  JA.
OHM ELECTRIC CO., LTD.
HAMAMATSU-SHI, SHIZUOKA,  JA.
Manufacturer;  
OHM ELECTRIC CO., LTD.
HAMAMATSU-SHI, SHIZUOKA,  JA.
OHMEDA MEDICAL
LAUREL,  MD,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI ,  US.

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Last Modified: 29 April 2006
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