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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
OPOLSKIE PRZEDSIEBIORSTWO INNIWACYJNO-WDROZENIOWE
OPOLE,  PL.
Manufacturer;  
OPOLSKIE PRZEDSIEBIORSTWO INNIWACYJNO-WDROZENIOWE
OPOLE,  PL.
OPPO ENT., INC.
TAIPEI HSIEN,  TW.
Manufacturer;  
OPPO ENT., INC.
TAIPEI HSIEN,  TW.
OPPO MEDICAL, INC.
TUKWILA,  WA,  US.
Initial Importer;  
OPPO MEDICAL, INC.
TUKWILA,  WA ,  US.
OPPORTUNITY IMPORTS, INC.
MILAN,  MI,  US.
Initial Importer;  
OPPORTUNITY IMPORTS, INC.
MILAN,  MI ,  US.
OPPORTUNITY, INC.
HIGHLAND PARK,  IL,  US.
Contract Manufacturer;   Repackager/Relabeller;  
OPPORTUNITY, INC.
HIGHLAND PARK,  IL ,  US.
OP'S OPTICAL PRODUCTS PTY LTD
CASTLE HILL, NSW,  AS.
Repackager/Relabeller;  
OP'S UNIT TRUST
CASTLE HILL, NSW,  AS.
OPSALES, INC.
ISLAND PARK,  NY,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
OPSALES, INC.
ISLAND PARK,  NY ,  US.
OPSO SALINE LIMITED
BARISAL,  BG.
Manufacturer;  
OPSO SALINE LIMITED
DHAKA,  BG.
OPT LINE
SEOTAEGU, TAEGU,  KS.
Manufacturer;  
OPT LINE
SEOTAEGU, TAEGU,  KS.
OPT. YS. INC.
FUKUI,  JA.
Foreign Exporter;  
OPT. YS. INC.
FUKUI,  JA.
OPTEC JAPAN CORP.
SABAE CITY, FUKUI PREF.,  JA.
Manufacturer;  
OPTEC JAPAN CORP.
SABAE CITY, FUKUI PREF.,  JA.
OPTEC SPECIALTIES, INC.
LAWRENCEVILLE,  GA,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
OPTEC SPECIALTIES, INC.
LAWRENCEVILLE,  GA ,  US.
OPTECH, INC.
ENGLEWOOD,  CO,  US.
Manufacturer;  
OPTECH, INC.
ENGLEWOOD,  CO ,  US.
OPTECH, INC. DBA SPECTACLES
NEW CANAAN,  CT,  US.
Initial Importer;  
OPTECH, INC. DBA SPECTACLES
NEW CANAAN,  CT ,  US.
OPTEGO VISION INC.
THORNHILL, ONTARIO,  CA.
Manufacturer;  
OPTEGO VISION INC.
THORNHILL, ONTARIO,  CA.
OPTELEC U.S., INC.
CHELMSFORD,  MA,  US.
Initial Importer;   Manufacturer;  
OPTELEC U.S., INC.
CHELMSFORD,  MA ,  US.
OPTEX
DAEGU,  KS.
Manufacturer;  
OPTEX
DAEGU,  KS.
OPTHALMED, INC.
CARLSBAD,  CA,  US.
Manufacturer;  
OPTHALMED, INC.
CARLSBAD,  CA ,  US.
OPTI CONSULTING EXPORT, INC.
MIAMI,  FL,  US.
Initial Importer;  
CR EYEWEAR INT'L
MIAMI,  FL ,  US.
OPTIC 2R
NOZEROY,  FR.
Unregistered Foreign Lister;  
OPTIC 2R
NOZEROY,  FR.
OPTIC EXPRESS, INC.
OAKHURST,  NJ,  US.
Initial Importer;  
U.D.S.
OAKHURST,  NJ ,  US.
OPTIC NATION
LOS ANGELES,  CA,  US.
Initial Importer;  
OPTIC NATION
LOS ANGELES,  CA ,  US.
OPTIC PRIMA CO., LTD.
FUKUI CITY,  JA.
Manufacturer;  
Y. AGATA, OPTIC PRIMA CO., LTD.
FUKUI CITY,  JA.
OPTIC TECH CORP.
MIAMI,  FL,  US.
Initial Importer;  
OPTIC TECH CORP.
MIAMI,  FL ,  US.
OPTIC TRADE LINK INDUSTRIES
BARODA, UNJARAT,  IN.
Unregistered Foreign Lister;  
OPTIC TRADE LINK INDUSTRIES
BARODA, UNJARAT,  IN.
OPTICA CREATION CO.
FUKUI,  JA.
Manufacturer;  
TADASHI SAITOH
FUKUI,  JA.
OPTICA FUKUI, INC.
OSAKA-543,  JA.
Manufacturer;  
OPTICA FUKUI, INC.
OSAKA-543,  JA.
OPTICA FUKUI, INC.
SABAE CITY, FUKUI PREF.,  JA.
Manufacturer;  
OPTICA FUKUI, INC.
SABAE CITY, FUKUI PREF.,  JA.
OPTICA LAUD
FORT WORTH,  TX,  US.
Initial Importer;  
OPTICA LAUD
FORT WORTH,  TX ,  US.
OPTICA SOLA DE MEXICO
TIJUANA, B.C.,  MX.
Manufacturer;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
OPTICA SOLA DE MEXICO
TIJUANA,BC,  MX.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
OPTICAL ACTIVITY LTD.
CAMBRIDGESHIRE, ENGLAND,  UK.
Unregistered Foreign Lister;  
OPTICAL ACTIVITY LTD.
CAMBRIDGESHIRE, ENGLAND,  UK.
OPTICAL ADVANTAGE
HIGHLAND PARK,  IL,  US.
Initial Importer;  
OPTICAL ADVANTAGE
HIGHLAND PARK,  IL ,  US.
OPTICAL CITY S.R.L.
TITO SCALO (PZ),  IT.
Unregistered Foreign Lister;  
OPTICAL CITY S.R.L.
TITO SCALO (PZ),  IT.
OPTICAL CONNECTION, INC.
SAN DIEGO,  CA,  US.
Initial Importer;   Manufacturer;  
OPTICAL CONNECTION, SAN DIEGO DIVISION
SAN DIEGO,  CA ,  US.
OPTICAL DESIGN AND MANUFACTURING CORP. LTD.
KOWLOON,  HK.
Foreign Exporter;   Remanufacturer;   Repackager/Relabeller;  
OPTICAL DESIGN AND MANUFACTURING CORP. LTD.
KOWLOON,  HK.
OPTICAL DESIGNS
SANTA MONICA,  CA,  US.
Initial Importer;  
OPTICAL DESIGNS
SANTA MONICA,  CA ,  US.
OPTICAL DIAGNOSTICS
CULEMBORG,  NL.
Manufacturer;  
OPTICAL DIAGNOSTICS
CULEMBORG,  NL.
OPTICAL DISPLAYS, INC.
NORTH MIAMI BEACH,  FL,  US.
Initial Importer;  
OPTICAL DISPLAYS, INC.
NORTH MIAMI BEACH,  FL ,  US.
OPTICAL DIVISION D.O.O.
BELGRADE, SERBIA,  SR.
Manufacturer;  
OPTICAL DIVISION
BELGRADE,SERBIA,  SR.

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Last Modified: 29 April 2006
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