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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
OLYMPIC MEDICAL CORP.
SEATTLE,  WA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
OLYMPIC MEDICAL CORP.
SEATTLE,  WA ,  US.
OLYMPIC RESCUE, INC.
ZION,  IL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OLYMPIC RESCUE, INC.
ZION,  IL ,  US.
OLYMPUS AMERICA, INC.
MELVILLE,  NY,  US.
Initial Importer;   Specification Developer;  
OLYMPUS CORPORATION
SHINJUKU-KU, TOKYO,  JA.
OLYMPUS CORPORATION
INA-SHI, NAGANO,  JA.
Manufacturer;  
OLYMPUS CORPORATION
SHINJUKU-KU, TOKYO,  JA.
OLYMPUS DIAGNOSTICA LAB AUTOMATION GMBH
MUNCHEN,  GM.
Specification Developer;  
OLYMPUS DIAGNOSTICA GMBH
HAMBURG,  GM.
OLYMPUS DIAGNOSTICA LAB-AUTOMATION GMBH
FREIBURG,  GM.
Manufacturer;  
OLYMPUS DIAGNOSTICA GMBH
HAMBURG,  GM.
OLYMPUS DIAGNOSTICA LAB-AUTOMATION GMBH
UMKIRCH,  GM.
Specification Developer;  
OLYMPUS DIAGNOSTICA GMBH
HAMBURG,  GM.
OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
O'CALLAGHANS MILLS, CO. CLARE,  EI.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OLYMPUS DIAGNOSTICA GMBH
HAMBURG,  GM.
OLYMPUS MEDICAL SYSTEMS CORPORATION
HACHIOJI-SHI,  JA.
Foreign Exporter;   Specification Developer;  
OLYMPUS MEDICAL SYSTEMS CORPORATION
HACHIOJI-SHI, TOKYO,  JA.
OLYMPUS MEDICAL SYSTEMS CORPORATION
NISHITAMA-GUN, TOKYO,  JA.
Foreign Exporter;   Manufacturer;   Specification Developer;  
OLYMPUS MEDICAL SYSTEMS CORPORATION
HACHIOJI-SHI, TOKYO,  JA.
OLYMPUS SURGICAL & INDUSTRIAL AMERICA, INC.
ORANGEBURG,  NY,  US.
Initial Importer;  
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
SOUTHEND-ON-SEA, ESSEX,  UK.
OLYMPUS WINTER & IBE GMBH
HAMBURG 70,  GM.
Foreign Exporter;   Manufacturer;  
OLYMPUS WINTER & IBE GMBH
HAMBURG 70,  GM.
OM HEALTHCARE PRODUCTS
PANVEL,  IN.
Manufacturer;  
OM HEALTHCARE PRODUCTS
PANVEL,  IN.
OMAREEF
SOORTS-HOSSEGOR,  FR.
Specification Developer;  
OMAREEF
SOORTS-HOSSEGOR,  FR.
OMAS SRL
SEGUSINO,  IT.
Manufacturer;  
OMAS SRL
SEGUSINO,  IT.
OMC PRECISION PRODUCTS, LTD.
INDIANAPOLIS,  IN,  US.
Contract Manufacturer;  
OMC PRECISION PRODUCTS, LTD.
INDIANAPOLIS,  IN ,  US.
OMEGA CRITICAL CARE LIMITED
EAST KILBRIDE,  UK.
Manufacturer;  
OMEGA CRITICAL CARE LIMITED
EAST KILBRIDE,  UK.
OMEGA DIAGNOSTICS, LTD.
ALVA, CLACKS,  UK.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OMEGA DIAGNOSTICS, LTD.
ALVA, CLACKS,  UK.
OMEGA GROUP, INC.
MIAMI,  FL,  US.

OMEGA GROUP, INC.
MIAMI,  FL ,  US.
OMEGA LABORATORIES, INC.
MOGADORE,  OH,  US.
Specification Developer;  
OMEGA LABORATORIES, INC.
MOGADORE,  OH ,  US.
OMEGA LASER SYSTEMS LTD.
CRAWLEY,  UK.
Manufacturer;  
OMEGA LASER SYSTEMS LTD.
CRAWLEY,  UK.
OMEGA MEDICAL IMAGING, INC.
SANFORD,  FL,  US.
Manufacturer;  
OMEGA MEDICAL IMAGING, INC.
SANFORD,  FL ,  US.
OMEGA MEDICAL PRODUCTS CORP.
YONKERS,  NY,  US.
Repackager/Relabeller;  
OMEGA MEDICAL PRODUCTS CORP.
YONKERS,  NY ,  US.
OMEGA MEDICAL SUPPLIES, INC.
NEW YORK,  NY,  US.
Initial Importer;  
OMEGA MEDICAL SUPPLIES, INC.
NEW YORK,  NY ,  US.
OMEGA OPTICAL CO.
TAEGU,  KS.
Unregistered Foreign Lister;  
OMEGA OPTICAL CO.
TAEGU,  KS.
OMEGA SILICONE, INC.
SANTA BARBARA,  CA,  US.
Manufacturer;  
COBEG
SANTA BARBARA,  CA ,  US.
OMEGA SURGICAL INSTRUMENTS, INC.
GRAND BLANC,  MI,  US.
Specification Developer;  
OMEGA SURGICAL INSTRUMENTS, INC.
GRAND BLANC,  MI ,  US.
OMEGAMETRIX, L.L.C.
KANSAS CITY,  MO,  US.
Repackager/Relabeller;  
OMEGAMETRIX, L.L.C.
KANSAS CITY,  MO ,  US.
OMEGAPOINT SYSTEMS, LLC
CINCINNATI,  OH,  US.
Manufacturer;  
OMEGAPOINT SYSTEMS, LLC
CINCINNATI,  OH ,  US.
OMEX TECHNOLOGIES, INC.
NORTHBROOK,  IL,  US.
Contract Manufacturer;   Manufacturer;  
OMEX TECHNOLOGIES, INC.
NORTHBROOK,  IL ,  US.
OMI MANUFACTURING PTY., LTD.
SLACKS CREEK, QUEENSLAND,  AS.
Foreign Exporter;   Manufacturer;   Specification Developer;  
OMI MANUFACTURING PTY., LTD.
SLACKS CREEK, QUEENSLAND,  AS.
OMICRON-DENTAL GMBH
LINDLAR, NRW,  GM.
Manufacturer;  
OMICRON-DENTAL GMBH
LINDLAR, NRW,  GM.
OMIDERM LTD.
HOLLYWOOD,  FL,  US.
Manufacturer;  
ITG-MEDEV, INC.
SAN FRANCISCO,  CA ,  US.
OMIDERM LTD.
YAVNE,  IS.
Unregistered Foreign Lister;  
OMIDERM LTD.
YAVNE,  IS.
OMNI HEARING SYSTEMS
CARROLLTON,  TX,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
STARKEY LABORATORIES, INC.
EDEN PRAIRIE,  MN ,  US.
OMNI INTERNATIONAL, LLC.
BEDFORD,  NH,  US.
Initial Importer;  
OMNI INTERNATIONAL, LLC.
BEDFORD,  NH ,  US.
OMNI LIFE SCIENCE
VISTA,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
OMNI LIFE SCIENCE
VISTA,  CA ,  US.
OMNI LIFE SCIENCE, INC.
LAKEVILLE,  MA,  US.
Specification Developer;  
OMNI LIFE SCIENCE
VISTA,  CA ,  US.
OMNI NATIONAL, LTD.
EL PASO,  TX,  US.
Contract Manufacturer;  
OMNI NATIONAL, LTD.
ALBUQUERQUE,  NM ,  US.
OMNI THERM, INC.
ST. LOUIS,  MO,  US.
Manufacturer;  
OMNI THERM, INC.
ST. LOUIS,  MO ,  US.

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Last Modified: 29 April 2006
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