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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
OPTICAL DYNAMICS CORPORATION
LOUISVILLE,  KY,  US.
Manufacturer;  
OPTICAL DYNAMICS CORPORATION
LOUISVILLE,  KY ,  US.
OPTICAL ELEMENTS, INC.
MIAMI,  FL,  US.
Initial Importer;  
OPTICAL ELEMENTS, INC.
MIAMI,  FL ,  US.
OPTICAL ENT., INC.
MIAMI,  FL,  US.
Initial Importer;  
MICHAEL E. BUDD
MIAMI,  FL ,  US.
OPTICAL EXPORTS, INC.
COOPER CITY,  FL,  US.
Initial Importer;  
OPTICAL EXPORTS, INC.
COOPER CITY,  FL ,  US.
OPTICAL FASHION TRADE
IRVINE,  CA,  US.
Initial Importer;  
OPTICAL FASHION TRADE
IRVINE,  CA ,  US.
OPTICAL GALLERY INC.
WASHINGTON,  DC,  US.
Initial Importer;  
OPTICAL GALLERY INC.
WASHINGTON,  DC ,  US.
OPTICAL IIJIMA CO., LTD.
TAKEFU CITY, FUKUI-PREF,  JA.
Manufacturer;  
OPTICAL IIJIMA CO., LTD.
TAKEFU CITY, FUKUI-PREF,  JA.
OPTICAL ILLUSIONS
BELLEVUE,  WA,  US.
Initial Importer;  
PARIS MIKI
REDMOND,  WA ,  US.
OPTICAL INTEGRITY, INC.
PANAMA CITY BEACH,  FL,  US.
Manufacturer;   Specification Developer;  
OPTICAL INTEGRITY, INC.
PANAMA CITY BEACH,  FL ,  US.
OPTICAL LABORATORY, INC.
NEW BEDFORD,  MA,  US.

OPTICAL LABORATORY, INC.
NEW BEDFORD,  MA ,  US.
OPTICAL MANAGEMENT ASSOCIATES, LLC
PARADISE VALLEY,  AZ,  US.
Initial Importer;  
OPTICAL MANAGEMENT ASSOCIATES, LLC
PARADISE VALLEY,  AZ ,  US.
OPTICAL OPTIONS
GREENWICH,  CT,  US.
Initial Importer;  
TOTAL VISION
GREENWICH,  CT ,  US.
OPTICAL PEOPLE, INC.
MIAMI,  FL,  US.
Initial Importer;  
OPTICAL PEOPLE, INC.
MIAMI,  FL ,  US.
OPTICAL POLYMER RESEARCH, INC.
GAINESVILLE,  FL,  US.
Manufacturer;  
OPTICAL POLYMER RESEARCH, INC.
GAINESVILLE,  FL ,  US.
OPTICAL SENSORS, INC.
EDEN PRAIRIE,  MN,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
OPTICAL SENSORS, INC.
EDEN PRAIRIE,  MN ,  US.
OPTICAL SERVICE S.R.L.
CORNUDA (TV),  IT.
Unregistered Foreign Lister;  
OPTICAL SERVICE S.R.L.
CORNUDA (TV),  IT.
OPTICAL SRL
LOZZO DI CADORE (BL),  IT.
Unregistered Foreign Lister;  
OPTICAL SRL
LOZZO DI CADORE (BL),  IT.
OPTICAL SUPPLIERS, INC.
AIEA,  HI,  US.
Contract Manufacturer;  
OPTICAL SUPPLIERS, INC.
AIEA,  HI ,  US.
OPTICAL SUPPLY, LLC
MIAMI,  FL,  US.
Initial Importer;  
OPTICAL SUPPLY, LLC
MIAMI,  FL ,  US.
OPTICAL SYSTEM INTEGRATION GMBH
NEUBERG,  GM.
Unregistered Foreign Lister;  
OPTICAL SYSTEM INTEGRATION GMBH
NEUBERG,  GM.
OPTICAL VENTURES, INC.
WEST COVINA,  CA,  US.
Initial Importer;   Specification Developer;  
OPTICAL VENTURES, INC.
WEST COVINA,  CA ,  US.
OPTICAL VENTURES, INC.
WEST COVINA,  CA,  US.
Manufacturer;  
OPTICAL VENTURES, INC.
WEST COVINA,  CA ,  US.
OPTICAL VIEW, INC.
FRAMINGHAM,  MA,  US.
Initial Importer;  
OPTICAL VIEW, INC.
FRAMINGHAM,  MA ,  US.
OPTICAL XPRESSIONS, LTD.
RONKONKOMA,  NY,  US.
Initial Importer;  
OPTICAL XPRESSIONS, LTD.
RONKONKOMA,  NY ,  US.
OPTICALDESIGN SRL
PEDEROBBA (TV),  IT.
Manufacturer;  
OPTICALDESIGN SRL
PEDEROBBA (TV),  IT.
OPTICARE ACQUISITION CORP.
YONKERS,  NY,  US.
Initial Importer;  
OPTICARE ACQUISITION CORP.
YONKERS,  NY ,  US.
OPTI-CENTRE LABORATORIES
SHERBROOK, QUEBEC,  CA.
Manufacturer;  
OPTI-CENTRE LABORATORIES
SHERBROOK, QUEBEC,  CA.
OPTICIANS 3
CHESTNUT HILL,  MA,  US.
Initial Importer;  
OPTICIANS 3
CHESTNUT HILL,  MA ,  US.
OPTICIANS-EYE-Q
NOVATO,  CA,  US.
Initial Importer;  
OPTICIANS-EYE-Q
NOVATO,  CA ,  US.
OPTICOM CO., LTD.
INCHON,  KS.
Manufacturer;  
OPTICOM CO., LTD.
INCHON,  KS.
OPTICON MEDICAL
DUBLIN,  OH,  US.
Manufacturer;  
OPMI FUNDING CORP.
DUBLIN,  OH ,  US.
OPTICON, INC.
FT. LAUDERDALE,  FL,  US.
Initial Importer;  
OPTICON, INC.
FT. LAUDERDALE,  FL ,  US.
OPTICOTE INC.
FRANKLIN PARK,  IL,  US.
Initial Importer;   Manufacturer;  
OPTICOTE INC.
FRANKLIN PARK,  IL ,  US.
OPTICTREND LTD.
COLCHESTER,  UK.
Manufacturer;  
OPTICTREND LTD.
COLCHESTER,  UK.
OPTIDECO SARL
OYANNAX,  FR.
Manufacturer;  
OPTIDECO SARL
OYANNAX,  FR.
OPTIDENT, LTD.
ILKLEY, WEST YORKSHIRE,  UK.
Repackager/Relabeller;  
OPTIDENT, LTD.
ILKLEY, WEST YORKSHIRE,  UK.
OPTI-EXPRESS
GUAYNABO,  PR,  US.
Initial Importer;  
OPTICAL OUTLET, INC.
GUAYNABO,  PR ,  US.
OPTIGEN SRL
LEGNANO, MILAN,  IT.
Manufacturer;   Remanufacturer;  
OPTIGEN SRL
LEGNANO, MILAN,  IT.
OPTIK K & R, INC.
PICKERING, ONTARIO,  CA.
Unregistered Foreign Lister;  
OPTIK K & R, INC.
PICKERING, ONTARIO,  CA.
OPTIKA LTD.
LONDON,  UK.
Foreign Exporter;  
OPTIKA LTD.
LONDON,  UK.

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Last Modified: 29 April 2006
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