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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
ORREX LTD., LLC
SANGER,  TX,  US.
Manufacturer;   Specification Developer;  
ORREX LTD., LLC
SANGER,  TX ,  US.
ORRICK INT'L. TRADING GROUP, INC.
ARCADIA,  CA,  US.
Initial Importer;  
WENZHOU ONO OPTICAL CO., LTD.
WENZHOU, ZHEJIANG,  CH.
ORTEAM S.R.L.
MILAN,  IT.
Unregistered Foreign Lister;  
ORTEAM S.R.L.
MILAN,  IT.
ORTEK AG
MERENSCHWAND,  SZ.
Contract Manufacturer;  
ORTEK AG
MERENSCHWAND, AARGAU,  SZ.
ORTEK THERAPEUTICS, INC.
ROSLYN HEIGHTS,  NY,  US.
Specification Developer;  
ORTEK THERAPEUTICS, INC.
ROSLYN HEIGHTS,  NY ,  US.
ORTEX SPOL S.R.O.
ZLIN,  EZ.
Manufacturer;  
ORTEX SPOL S.R.O.
ZLIN,  EZ.
ORTHAHEEL USA, LTD.
PALM BEACH,  FL,  US.
Initial Importer;  
ORTHAHEEL USA, LTD.
PALM BEACH,  FL ,  US.
ORTHEON MEDICAL, LLC.
WINTER PARK,  FL,  US.
Manufacturer;  
ORTHEON MEDICAL, LLC.
WINTER PARK,  FL ,  US.
ORTHO ACTIVE APPLIANCES LTD.
COQUITLAM, B.C.,  CA.
Manufacturer;  
ORTHO ACTIVE APPLIANCES LTD.
COQUITLAM B.C.,  CA.
ORTHO CLASSIC
LAS VEGAS,  NV,  US.
Initial Importer;  
ORTHO CLASSIC
LAS VEGAS,  NV ,  US.
ORTHO DEVELOPMENT CORP.
DRAPER,  UT,  US.
Manufacturer;   U.S. Manufacturer of Export Only Devices;
ORTHO DEVELOPMENT CORP.
DRAPER,  UT ,  US.
ORTHO EUROPE LTD.
ABINGDON,OXON,  UK.
Manufacturer;  
ORTHO EUROPE LTD.
ABINGDON,OXON,  UK.
ORTHO INNOVATIONS, INC.
ROCHESTER,  MN,  US.
Manufacturer;  
ORTHO INNOVATIONS, INC.
ROCHESTER,  MN ,  US.
ORTHO KINETICS CORP.
VISTA,  CA,  US.
Manufacturer;  
ORTHO KINETICS CORP.
VISTA,  CA ,  US.
ORTHO MEDICAL GMBH IMPLANTS
DUERBHEIM,  GM.
Manufacturer;  
ORTHO MEDICAL GMBH IMPLANTS
DUERBHEIM,  GM.
ORTHO ORGANIZERS, INC.
SAN MARCOS,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ORTHO ORGANIZERS, INC.
SAN MARCOS,  CA ,  US.
ORTHO PAUHER IND. COM. E DIST. LTDA
RECIFE, PE,  BR.
Foreign Exporter;   Manufacturer;  
ORTHO PAUHER IND. COM. E DIST. LTDA
RECIFE, PE,  BR.
ORTHO PLUS SA
IGNY,  FR.
Manufacturer;  
ORTHO PLUS SA
IGNY,  FR.
ORTHO SWISS
FORCH,  SZ.
Unregistered Foreign Lister;  
ORTHO SWISS
FORCH,  SZ.
ORTHO TECHNOLOGY
TAMPA,  FL,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ORTHO TECHNOLOGY
TAMPA,  FL ,  US.
ORTHO U.S.A., INC.
CHELSA,  MA,  US.
Initial Importer;  
PATTI RUBIN
BOSTON,  MA ,  US.
ORTHOBIL/DR. ANDREI BILCIURESCU GMBH
BONN,  GM.
Unregistered Foreign Lister;  
ORTHOBIL/DR. ANDREI BILCIURESCU GMBH
BONN,  GM.
ORTHO-BYTE.COM INC.
WILMINGTON,  DE,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ORTHO-BYTE.COM INC.
WILMINGTON,  DE ,  US.
ORTHO-CARE (UK) LTD
BRADFORD,  UK.
Foreign Exporter;   Manufacturer;  
ORTHO-CARE (UK) LTD
BRADFORD,  UK.
ORTHO-CARE, INC.
RAYTOWN,  MO,  US.
Initial Importer;   Manufacturer;  
ORTHO-CARE, INC.
RAYTOWN,  MO ,  US.
ORTHOCLEAR INC.
SAN CARLOS,  CA,  US.
Specification Developer;  
ORTHORCLEAR, INC.
SAN FRANCISCO,  CA ,  US.
ORTHOCLEAR PAKISTAN PVT. LTD.
LAHORE,  PK.
Manufacturer;  
ORTHORCLEAR, INC.
SAN FRANCISCO,  CA ,  US.
ORTHO-CLINICAL DIAGNOSTICS
CARDIFF,  UK.
Manufacturer;   Specification Developer;  
ORTHO-CLINICAL DIAGNOSTICS, INC.
ROCHESTER,  NY ,  US.
ORTHO-CLINICAL DIAGNOSTICS, INC.
RARITAN,  NJ,  US.
Initial Importer;   Manufacturer;  
ORTHO-CLINICAL DIAGNOSTICS, INC.
RARITAN,  NJ ,  US.
ORTHO-CLINICAL DIAGNOSTICS, INC.
ROCHESTER,  NY,  US.
Manufacturer;  
ORTHO-CLINICAL DIAGNOSTICS, INC.
ROCHESTER,  NY ,  US.
ORTHO-CLINICAL DIAGNOSTICS, INC.
ROCHESTER,  NY,  US.
Contract Manufacturer;   Manufacturer;  
ORTHO-CLINICAL DIAGNOSTICS, INC.
ROCHESTER,  NY ,  US.
ORTHO-CLINICAL DIAGNOSTICS, INC.
ROCHESTER,  NY,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ORTHO-CLINICAL DIAGNOSTICS, INC.
ROCHESTER,  NY ,  US.
ORTHO-CRAFT, INC.
FAIRFIELD,  NJ,  US.
Contract Manufacturer;  
PARAGON MEDICAL, INC.
PIERCETON,  IN ,  US.
ORTHOCRAT
PETACH TIKVA,  IS.
Manufacturer;  
ORTHOCRAT
PETACH TIKVA,  IS.
ORTHODENTAL INTL., INC.
CALEXICO,  CA,  US.
Initial Importer;  
ORTHODENTAL INTL., INC.
CALEXICO,  CA ,  US.
ORTHODENTAL S.A. DE C.V.
MEXICALI B.C.,  MX.
Manufacturer;  
ORTHODENTAL S.A. DE C.V.
MEXICALI B.C.,  MX.
ORTHODOCS LIMITED
BELFAST,  EI.
Foreign Exporter;   Manufacturer;   Specification Developer;  
ORTHODOCS LIMITED
BELFAST,  EI.
ORTHODONTIC DESIGN AND PRODUCTION, INC.
VISTA,  CA,  US.
Contract Manufacturer;   Manufacturer;  
ORTHODONTIC DESIGN AND PRODUCTION, INC.
VISTA,  CA ,  US.
ORTHODONTIC MANUFACTURER SIA SRL
ROCCA D'EVANDRO (CE),  IT.
Manufacturer;  
ORTHODONTIC MANUFACTURER SIA SRL
ROCCA D'EVANDRO (CE),  IT.
ORTHODONTIC SUPPLY & EQUIPMENT CO., INC.
GAITHERSBURG,  MD,  US.
Initial Importer;   Repackager/Relabeller;  
ORTHODONTIC SUPPLY & EQUIPMENT CO., INC.
GAITHERSBURG,  MD ,  US.

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Last Modified: 29 April 2006
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