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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
OPTI-TINT, INC.
JUPITER,  FL,  US.
Initial Importer;  
OPTI-TINT, INC.
JUPITER,  FL ,  US.
OPTIVUS TECHNOLOGY, INC.
SAN BERNARDINO,  CA,  US.
Manufacturer;  
OPTIVUS TECHNOLOGY, INC.
SAN BERNARDINO,  CA ,  US.
OPTIWORK S.R.L.
REGGIO EMILIA,  IT.
Foreign Exporter;   Manufacturer;  
OPTIWORK S.R.L.
REGGIO EMILIA,  IT.
OPTO ALPHA
SHINJUKU-KU,  JA.
Manufacturer;  
OPTO ALPHA
SHINJUKU-KU,  JA.
OPTO CIRCUIT INDIA, LTD
BANGALORE SOUTH, KARNATAKA,  IN.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;   Remanufacturer;  
OPTO CIRCUIT INDIA, LTD
BANGALORE SOUTH, KARNATAKA,  IN.
OPTO ELECTRONICA SA
SAO CARLOS, SP,  BR.
Manufacturer;  
OPTO ELECTRONICA SA
SAO CARLOS, SP,  BR.
OPTO SENSORS (M) SDN. BHD.
JOHOR BAHRU,  MY.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
OPTO SENSORS (M) SDN. BHD.
JOHOR BAHRU,  MY.
OPTO SYSTEM(S) PTE LTD
SINGAPORE,  SN.
Contract Manufacturer;  
OPTO SYSTEM(S) PTE LTD
SINGAPORE,  SN.
OPTO USA CORP.
NORTH MIAMI,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
OPTO ELECTRONICA SA
SAO CARLOS, SP,  BR.
OPTODEV, INC.
MAMPLASAN, BINAN,  RP.
Manufacturer;  
ESSILOR INTERNATIONAL, S.A.
CHARENTON, CEDEX,  FR.
OPTOLENTES LENTES DE CONTATO LTDA
PORTO ALEGRE,  BR.
Unregistered Foreign Lister;  
OPTOLENTES LENTES DE CONTATO LTDA
PORTO ALEGRE,  BR.
OPTOLINE S.R.L.
SEGUSINO (TV),  IT.
Manufacturer;  
OPTOLINE S.R.L.
SEGUSINO (TV),  IT.
OPTOMED INC.
MIAMI,  FL,  US.
Initial Importer;  
OPTOMED INC.
MIAMI,  FL ,  US.
OPTOMED S.A.
BUENOS AIRES,  AR.
Unregistered Foreign Lister;  
OPTOMED S.A.
BUENOS AIRES,  AR.
OPTOMEDIC MEDICAL TECHNOLOGIES LTD.
IS.
Manufacturer;  
OPTOMEDIC MEDICAL TECHNOLOGIES LTD.
IS.
OPTOMETRIC CENTER OF ENCINO
ENCINO,  CA,  US.
Initial Importer;  
OPTOMETRIC CENTER OF ENCINO
ENCINO,  CA ,  US.
OPTOMIC ESPANA, S.A.
COLMENAR VIEJO (MADRID),  SP.
Manufacturer;  
OPTOMIC ESPANA, S.A.
COLMENAR VIEJO (MADRID),  SP.
OPTONOL, LTD
NEVE ILAN,  IS.
Manufacturer;  
OPTONOL, LTD
NEVE ILAN,  IS.
OPTOS PLC
DUNFERMLINE, FIFE,  UK.
Manufacturer;  
OPTOS PLC
DUNFERMLINE, FIFE,  UK.
OPTOS, INC.
MARLBOROUGH,  MA,  US.
Initial Importer;   Manufacturer;  
OPTOS PLC
DUNFERMLINE, FIFE,  UK.
OPTO-SYSTEMS, INC.
NEWTOWN,  PA,  US.

OPTO-SYSTEMS, INC.
NEWTOWN,  PA ,  US.
OPTOVENT AB
TABY,  SW.
Manufacturer;   Specification Developer;  
OPTOVENT AB
TABY,  SW.
OPTYGEM S.N.C.
VALDOBBIADENE,  IT.
Manufacturer;  
OPTYGEM S.N.C.
VALDOBBIADENE,  IT.
OPTYL HOLDING GMBH & CO. VKG
HAAR/MUNICH D-8013,  GM.
Manufacturer;  
OPTYL HOLDING GMBH & CO. VKG
HAAR/MUNICH D-8013,  GM.
OPUS DENT LTD.
NATANIA SOUTH,  IS.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
LUMENIS LTD.
YOKNEAM,  IS.
OPUSMED INC.
MOUNT ROYAL, QC,  CA.
Manufacturer;  
OPUSMED INC.
MOUNT ROYAL, QC,  CA.
ORA OPTICAL, INC.
BROOKLYN,  NY,  US.
Initial Importer;  
ORA OPTICAL, INC.
BROOKLYN,  NY ,  US.
ORACEUTICAL LLC
LEE,  MA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ORACEUTICAL LLC
LEE,  MA ,  US.
ORACLE LENS MFG. CORP.
WARWICK,  RI,  US.
Contract Manufacturer;   Manufacturer;  
ORACLE LENS MFG.,
WARWICK,  RI ,  US.
ORAL ART-DENTAL RECREATIONS & RESTORATIONS
LAS VEGAS,  NV,  US.
Repackager/Relabeller;  
ORAL ART-DENTAL RECREATIONS & RESTORATIONS
LAS VEGAS,  NV ,  US.
ORAL CARE TECHNOLOGIES, INC.
BESSEMER,  AL,  US.
Initial Importer;  
ORAL CARE TECHNOLOGIES, INC.
BESSEMER,  AL ,  US.
ORAL CERAMIC LABORATORY, INC.
TORONTO, ONTARIO,  CA.
Contract Manufacturer;   Manufacturer;  
ORAL CERAMIC LABORATORY, INC.
TORONTO, ONTARIO,  CA.
ORAL HEALTH PRODUCTS, INC.
TULSA,  OK,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ORAL HEALTH PRODUCTS, INC.
TULSA,  OK ,  US.
ORAL HEALTH USA, INC.
PISCATAWAY,  NJ,  US.
Initial Importer;   Repackager/Relabeller;  
ORAL HEALTH USA, INC.
PISCATAWAY,  NJ ,  US.
ORAL OSTEODISTRACTION, L.P.
BUFFALO GROVE,  IL,  US.
Manufacturer;  
ORAL OSTEODISTRACTION, L.P.
BUFFALO GROVE,  IL ,  US.
ORAL-B IRELAND
NEWBRIDGE, CO. KILDARE,  EI.
Manufacturer;  
THE GILLETTE COMPANY
BOSTON,  MA ,  US.
ORAL-B LABORATORIES
IOWA CITY,  IA,  US.
Initial Importer;   Manufacturer;  
GILLETTE CANADA, INC.
KIRKLAND QUEBEC,  CA.
ORAL-B LABORATORIES
COUNTY KILDARE,  EI.
Unregistered Foreign Lister;  
ORAL-B LABORATORIES
COUNTY KILDARE,  EI.
ORALBOTIC RESEARCH, INC.
ESCONDIDO,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
ORALBOTIC RESEARCH, INC.
ESCONDIDO,  CA ,  US.
ORALDENT LIMITED
KIMBOLTON, CAMBRIDGESHIRE,  UK.
Foreign Exporter;   Manufacturer;  
ORALDENT LIMITED
KIMBOLTON, CAMBRIDGESHIRE,  UK.

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Last Modified: 29 April 2006
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