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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
ORTO IBERICA S.L.
GRANDA-SIERO, ASTURIAS,  SP.
Foreign Exporter;   Contract Manufacturer;  
ORTO IBERICA S.L.
GRANDA-SIERO, ASTURIAS,  SP.
ORTO TEC SA DE CV
CIUDAD DE MEXICO, DISTRITO FED,  MX.
Foreign Exporter;  
ORTO TEC SA DE CV
CIUDAD DE MEXICO, DISTRITO FED,  MX.
ORT-OBEA, S.A.
ANDOAIN,  SP.
Manufacturer;  
ORT-OBEA, S.A.
ANDOAIN,  SP.
ORTOPEDICOS FUTURO
BOGOTA,  CO.
Foreign Exporter;   Manufacturer;  
ORTOPEDICOS FUTURO
BOGOTA,  CO.
ORTOSIM, S.A. DE C.V.
TLALNEPANTLA, EDO.DE MEX.,  MX.
Contract Manufacturer;  
FERNANDO MORALES GARFIAS
TLALNEPANTLA, EDO.DE MEX.,  MX.
ORTOSINTESE INDUSTRIA E COMMERICO LTDA
SAO PAULO,  BR.
Contract Manufacturer;  
ORTOSINTESE INDUSTRIA E COMMERICO LTDA
SAO PAULO,  BR.
ORTO-TEC S.A. DE C.V.
MEXICO CITY,  MX.
Contract Manufacturer;   Manufacturer;  
ORTO-TEC S.A. DE C.V.
MEXICO CITY,  MX.
ORTOVOX SPORTARTIKEL GMBH
TAUFKISCHEN,  GM.
Unregistered Foreign Lister;  
ORTOVOX SPORTARTIKEL GMBH
TAUFKISCHEN,  GM.
ORVIM SRL
PADERNO (MI),  IT.
Contract Manufacturer;  
ORVIM SRL
DESIO (MI),  IT.
O'RYAN INDUSTRIES
VANCOUVER,  WA,  US.
Initial Importer;  
O'RYAN INDUSTRIES
VANCOUVER,  WA ,  US.
OSACHI CO., LTD.
OKAYA-SHI, NAGANO,  JA.
Manufacturer;  
OSACHI CO., LTD.
OKAYA-SHI, NAGANO,  JA.
OSADA ELECTRIC CO., LTD.
TOKYO,  JA.
Manufacturer;  
OSADA ELECTRIC CO., LTD.
TOKYO,  JA.
OSADA, INC.
LOS ANGELES,  CA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
OSADA ELECTRIC CO., LTD.
TOKYO,  JA.
OSAKI MEDICAL CORPORATION
NAGOYA, AICHI,  JA.
Manufacturer;  
OSAKI MEDICAL CORPORATION
NAGOYA, AICHI,  JA.
OSBORN MEDICAL CORP.
UTICA,  MN,  US.
Initial Importer;   Manufacturer;  
OSBORN MEDICAL CORP.
UTICA,  MN ,  US.
OSBORN SCIENTIFIC GROUP
PINETOP,  AZ,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OSBORN SCIENTIFIC GROUP
PINETOP,  AZ ,  US.
OSCAR & DEHN LTD.
LONDON,  UK.
Manufacturer;  
OSCAR & DEHN LTD.
LONDON,  UK.
OSCAR BEAUTY, LLC
CITY OF INDUSTRY,  CA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
OSCAR BEAUTY, LLC
CITY OF INDUSTRY,  CA ,  US.
OSCAR, INC.
FISHERS,  IN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OSCAR, INC.
FISHERS,  IN ,  US.
OSCITRONIC S.A.
LA CHAUX-DE-FONDS,  SZ.
Manufacturer;  
OSCITRONIC S.A.
LA CHAUX-DE-FONDS,  SZ.
OSCOR CARIBE LLC
SANTO DOMINGO,  DR.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;   Contract Sterilizer;   Repackager/Relabeller;  
OSCOR CARIBE LLC
PALM HARBOR,  FL ,  US.
OSCOR INC.
PALM HARBOR,  FL,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
OSCOR INC.
PALM HARBOR,  FL ,  US.
OSG CORPORATION, LTD.
OSAKA,  JA.
Manufacturer;  
OSG CORPORATION, LTD.
OSAKA,  JA.
OSHIN PHARMACEUTICAL CO., LTD.
FUKUI,  JA.
Manufacturer;  
OSHIN PHARMACEUTICAL CO., LTD.
FUKUI,  JA.
OSI ELECTRONICS BOSTON
NORTH ANDOVER,  MA,  US.
Contract Manufacturer;  
OSI ELECTRONICS BOSTON
NORTH ANDOVER,  MA ,  US.
OSI ELECTRONICS, INC.
CAMARILLO,  CA,  US.
Contract Manufacturer;  
OSI ELECTRONICS, INC.
CAMARILLO,  CA ,  US.
OSI PHARMACEUTICALS, INC.
MELVILLE,  NY,  US.
Initial Importer;  
OSI PHARMACEUTICALS, INC.
MELVILLE,  NY ,  US.
OSI SYSTEMS PVT., LTD.
ANDHRA PRADESH,  IN.
Contract Manufacturer;  
OSI SYSTEMS PVT., LTD.
ANDHRA PRADESH,  IN.
OSIM INTERNATIONAL LTD.
SINGAPORE,  SN.
Specification Developer;  
OSIM INTERNATIONAL LTD.
SINGAPORE,  SN.
OSIRIS ENTERPRISES, INC.
FREDERICK,  MD,  US.
Specification Developer;  
OSIRIS ENTERPRISES, INC.
FREDERICK,  MD ,  US.
OSKAR KELLER, INH. GERHARD KELLER
TUTTLINGEN,  GM.
Manufacturer;  
OSKAR KELLER, INH. GERHARD KELLER
TUTTLINGEN,  GM.
OSM GMBH
DUSSELDORF,  GM.
Manufacturer;  
OSM GMBH
DUSSELDORF,  GM.
OSM, INC.
LEVITTOWN,  NY,  US.
Specification Developer;  
OSM CONSULTANTS, INC.
LEVITTOWN,  NY ,  US.
OSMED, GMBH
ILMENAU,  GM.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
OSMED, GMBH
ILMENAU,  GM.
OSMETECH, INC.
ROSWELL,  GA,  US.
Manufacturer;   Specification Developer;  
OSMETECH, PLC.
LONDON, ENGLAND,  UK.
OSPREY CAPITAL GROUP
MIAMI,  FL,  US.
Initial Importer;  
OSPREY CAPITAL GROUP
MIAMI,  FL ,  US.
OSRAM CHINA LIGHTING LTD.
FOSHAN, GUANGDONG,  CH.
Contract Manufacturer;   Manufacturer;  
OSRAM GMBH
MUNCHEN,  GM.
OSRAM DE MEXICO
TEPOTZOTLAN, ESTADO DE MEXICO,  MX.
Manufacturer;  
OSRAM SYLVANIA, INC.
DANVERS,  MA ,  US.
OSRAM SYLVANIA LTD./LTEE
DRUMMONDVILLE,QUEBEC,  CA.
Manufacturer;  
OSRAM SYLVANIA, INC.
DANVERS,  MA ,  US.
OSRAM SYLVANIA, INC.
WARREN,  PA,  US.
Contract Manufacturer;   Manufacturer;  
OSRAM SYLVANIA, INC.
DANVERS,  MA ,  US.

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Last Modified: 29 April 2006
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