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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
OPTIKA MAYA
SKOPLJE,  MK.
Unregistered Foreign Lister;  
OPTIKA MAYA
SKOPLJE,  MK.
OPTIKEM INTERNATIONAL, INC.
DENVER,  CO,  US.
Manufacturer;  
WILSA, INC.
DENVER,  CO ,  US.
OPTIKON 2000 SPA
ROMA, RM,  IT.
Manufacturer;  
OPTIKON 2000 SPA
ROMA, RM,  IT.
OPTIKOREA CO.
DAEGU,  KS.
Manufacturer;  
OPTIKOREA CO.
DAEGU,  KS.
OPTILASA S.L.
MADRID,  SP.
Manufacturer;  
OPTILASA S.L.
MADRID,  SP.
OPTILINE, INC.
VAN NUYS,  CA,  US.
Initial Importer;  
OPTILINE, INC.
VAN NUYS,  CA ,  US.
OPTI-LITE OPTICAL
LOS ANGELES,  CA,  US.
Initial Importer;  
OPTI-LITE OPTICAL
LOS ANGELES,  CA ,  US.
OPTIM, INC.
STURBRIDGE,  MA,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
OPTIM, INC.
STURBRIDGE,  MA ,  US.
OPTIMA HEALTHCARE, INC.
TAO-YUAN HSIEN,  TW.
Manufacturer;  
OPTIMA HEALTHCARE, INC.
TAO-YUAN HSIEN,  TW.
OPTIMA MEDICAL EQUIPMENT CORP.
MIAMI,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
OPTIMA MEDICAL EQUIPMENT CORP.
MIAMI,  FL ,  US.
OPTIMA OCCHIALERIA S.R.L.
S. NICOLO' DI COMELICO, B.L.,  IT.
Manufacturer;  
OPTIMA OCCHIALERIA S.R.L.
S. NICOLO' DI COMELICO, B.L.,  IT.
OPTIMA USA, INC.
ELK GROVE VILLAGE,  IL,  US.
Initial Importer;  
OPTIMA USA, INC.
ELK GROVE VILLAGE,  IL ,  US.
OPTIMA, INC.
TOKYO,  JA.
Unregistered Foreign Lister;  
OPTIMA, INC.
TOKYO,  JA.
OPTIMA, INC.
STRATFORD,  CT,  US.
Initial Importer;  
OPTIMA, INC.
STRATFORD,  CT ,  US.
OPTIMAL ORTHO
LINDEW,  NJ,  US.
Initial Importer;  
OPTIMAL ORTHO
LINDEW,  NJ ,  US.
OPTIMAL, INC.
STAFFORD,  TX,  US.
Initial Importer;  
OPTIMAL, INC.
STAFFORD,  TX ,  US.
OPTIMALIFE USA, INC.
HOLLYWOOD,  FL,  US.
Initial Importer;  
OPTIMALIFE USA, INC.
HOLLYWOOD,  FL ,  US.
OPTIMARK
SEATTLE,  WA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
OPTIMARK
SEATTLE,  WA ,  US.
OPTIMATE, INC.
ARCADIA,  CA,  US.
Initial Importer;  
OPTIMATE, INC.
ARCADIA,  CA ,  US.
OPTIMAX VISION GROUP
LAWRENVILLE,  GA,  US.
Initial Importer;  
CHRISTIAN NONIRIT
LAWRENVILLE,  GA ,  US.
OPTI-MAX, INC.
PORT LUDLOW,  WA,  US.
Specification Developer;  
OPTI-MAX, INC.
PORT LUDLOW,  WA ,  US.
OPTIMED TECHNOLOGIES, INC.
FAIRFIELD,  NJ,  US.
Manufacturer;  
OPTIMED TECHNOLOGIES, INC.
FAIRFIELD,  NJ ,  US.
OPTIMETRICS, INC.
MIAMI,  FL,  US.
Initial Importer;  
OPTIMETRICS, INC.
PEMBROKE PINES,  FL ,  US.
OPTIMODE INC.
MISSISSAUGA ONTARIO,  CA.
Foreign Exporter;  
OPTIMODE INC.
MISSISSAUGA ONTARIO,  CA.
OPTIMUM TECHNOLOGIES, INC.
SOUTHBRIDGE,  MA,  US.
Contract Manufacturer;  
OPTIMUM TECHNOLOGIES, INC.
SOUTHBRIDGE,  MA ,  US.
OPTI-NETWORK, INC.
MIAMI BEACH,  FL,  US.
Initial Importer;  
OPTI-NETWORK, INC.
MIAMI BEACH,  FL ,  US.
OPTINOSE AS
OSLO,  NO.
Foreign Exporter;   Manufacturer;   Specification Developer;  
OPTINOSE AS
OSLO,  NO.
OPTION CARE
WAYCROSS,  GA,  US.

OPTION CARE
WAYCROSS,  GA ,  US.
OPTION MEDICAL, INC.
PORT ANGELES,  WA,  US.
Manufacturer;   Specification Developer;  
OPTION MEDICAL, INC.
PORT ANGELES,  WA ,  US.
OPTIONS, INC.
BIG LAKE,  MN,  US.
Contract Manufacturer;  
OPTIONS, INC.
BIG LAKE,  MN ,  US.
OPTIQ LTD.
CONCORD, ONTARIO,  CA.
Specification Developer;  
OPTIQ LTD.
CONCORD, ONTARIO,  CA.
OPTIQUE AMERICA
CARMEL,  CA,  US.
Initial Importer;  
OPTIQUE AMERICA
CARMEL,  CA ,  US.
OPTIQUE CLASSIQUE, LLC
ATLANTA,  GA,  US.
Initial Importer;  
OPTIQUE CLASSIQUE, LLC
ATLANTA,  GA ,  US.
OPTIQUE, INC.
PHILADELPHIA,  PA,  US.
Initial Importer;  
OPTIQUE INTL., LTD.
PHILADELPHIA,  PA ,  US.
OPTIQUES GEORGES LAOUN INC.
MONTREAL,  CA.
Foreign Exporter;  
OPTIQUES GEORGES LAOUN INC.
MONTREAL,  CA.
OPTISCAN PTY LTD.
NOTTING HILL VIC,  AS.
Manufacturer;  
OPTISCAN PTY LTD.
NOTTING HILL VIC,  AS.
OPTISOL INDUSTRIA OTICA LTDA.
RIO DE JANEIRO,  BR.
Manufacturer;  
OPTISOL INDUSTRIA OTICA LTDA.
RIO DE JANEIRO,  BR.
OPTISONIC, INC.
ST. THOMAS, ONTARIO,  CA.
Manufacturer;  
OPTISONIC, INC.
ST. THOMAS, ONTARIO,  CA.
OPTISUN
OYONNAX,  FR.
Manufacturer;  
OPTISUN
OYONNAX,  FR.
OPTITAL SRL
LOZZO DI CADORE (BL),  IT.
Manufacturer;  
OPTITAL SRL
LOZZO DI CADORE (BL),  IT.

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Last Modified: 29 April 2006
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