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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
OMNI TRADE GROUP, INC.
DALLAS,  TX,  US.
Initial Importer;  
OMNI TRADE GROUP, INC.
DALLAS,  TX ,  US.
OMNIA SRL
FIDENZA,  IT.
Manufacturer;  
OMNIA SRL
FIDENZA,  IT.
OMNIA, INC.
LAKELAND,  FL,  US.
Contract Manufacturer;   Manufacturer;  
OMNIA, INC.
LAKELAND,  FL ,  US.
OMNICAL, INC.
SAN FERNANDO,  CA,  US.
Manufacturer;  
OMNICAL, INC.
SAN FERNANDO,  CA ,  US.
OMNICARE DENTAL IMPLANT CENTER
NEW YORK,  NY,  US.
Manufacturer;   Specification Developer;  
OMNICARE DENTISTRY
NEW YORK,  NY ,  US.
OMNIDYNE CORP.
COPIAGUE,  NY,  US.
Manufacturer;  
OMNIDYNE CORP.
COPIAGUE,  NY ,  US.
OMNIFACET CORPORATION
JACKSONVILLE,  FL,  US.
Initial Importer;  
OMNIFACET CORPORATION
JACKSONVILLE,  FL ,  US.
OMNIGLOW CORP.
WEST SPRINGFIELD,  MA,  US.
Contract Manufacturer;  
OMNIGLOW CORP.
WEST SPRINGFIELD,  MA ,  US.
OMNIGRACE (THAILAND) LTD.
HATYAI, SONGKHLA,  TH.
Manufacturer;  
OMNIGRACE (THAILAND) LTD.
HATYAI, SONGKHLA,  TH.
OMNIGUIDE, INC.
CAMBRIDGE,  MA,  US.
Manufacturer;  
OMNIGUIDE, INC.
CAMBRIDGE,  MA ,  US.
OMNII ORAL PHARMACEUTICALS
GRAVETTE,  AR,  US.
Initial Importer;   Repackager/Relabeller;  
OMNII ORAL PHARMACEUTICALS
WEST PALM BEACH,  FL ,  US.
OMNII PRODUCTS OF PALM BEACH, INC.
WEST PALM BEACH,  FL,  US.
Initial Importer;  
OMNII PRODUCTS OF PALM BEACH, INC.
WEST PALM BEACH,  FL ,  US.
OMNILIGHT PERFORMANCE DEVICES, INC
ALBUQUERQUE,  NM,  US.
Repackager/Relabeller;  
OMNILIGHT PERFORMANCE DEVICES, INC
ALBUQUERQUE,  NM ,  US.
OMNIQUR, INC.
CITY OF INDUSTRY,  CA,  US.
Initial Importer;   Manufacturer;  
OMNIQUR, INC.
CITY OF INDUSTRY,  CA ,  US.
OMNISONICS MEDICAL TECHNOLOGIES
WILMINGTON,  MA,  US.
Manufacturer;   Specification Developer;  
OMNISONICS MEDICAL TECHNOLOGIES
WILMINGTON,  MA ,  US.
OMNISOURCE MARKETING GROUP, INC.
INDIANAPOLIS,  IN,  US.
Initial Importer;  
OMNISOURCE MARKETING GROUP, INC.
INDIANAPOLIS,  IN ,  US.
OMNITECH SYSTEMS, INC.
VALPARAISO,  IN,  US.
Contract Manufacturer;   Manufacturer;  
OMNITECH SYSTEMS, INC.
VALPARAISO,  IN ,  US.
OMNITEK,INCORPORATED
LEXINGTON,  KY,  US.
Manufacturer;  
OMNITEK,INCORPORATED
LEXINGTON,  KY ,  US.
OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.
ST. PAUL,  MN,  US.
Manufacturer;  
OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.
ST. PAUL,  MN ,  US.
OMNIWARE
ARCADIA,  CA,  US.
Initial Importer;  
OMNIWARE
ARCADIA,  CA ,  US.
OMPU
SALTSJO-BOO,  SW.
Manufacturer;  
OMPU
SALTSJO-BOO,  SW.
OMRIX BIOPHARMACEUTICALS LTD.
RAMAT GAN,  IS.
Manufacturer;  
OMRIX BIOPHARMACEUTICALS LTD.
RAMAT GAN,  IS.
OMRON (CHINA) CO., LTD.
DALIAN,  CH.
Unregistered Foreign Lister;  
OMRON (CHINA) CO., LTD.
DALIAN,  CH.
OMRON (DALIAN) CO., LTD. (PLANT 1)
DALIAN,  CH.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OMRON (DALIAN) CO., LTD. (PLANT 1)
DALIAN,  CH.
OMRON (DALIAN) CO., LTD. (PLANT 2)
ZONE, DALIAN,  CH.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OMRON (DALIAN) CO., LTD. (PLANT 1)
DALIAN,  CH.
OMRON HEALTHCARE CO., LTD.
KYOTO,  JA.
Foreign Exporter;   Specification Developer;  
OMRON HEALTHCARE CO., LTD.
KYOTO,  JA.
OMRON HEALTHCARE, INC.
BANNOCKBURN,  IL,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
OMRON HEALTHCARE, INC.
BANNOCKBURN,  IL ,  US.
OMRON MATSUSAKA CO. LTD.
MATSUSAKA-CITY MIE-PREFECTURE,  JA.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OMRON MATSUSAKA CO. LTD.
MATSUSAKA-CITY MIE-PREFECTURE,  JA.
OMS 177108 CANADA, INC.
MONTREAL QUEBEC,  CA.
Manufacturer;  
OMS 177108 CANADA, INC.
POINTE CLAIRE, QUEBEC,  CA.
OMS 177108 CANADA, INC.
CHAMPLAIN,  NY,  US.
Initial Importer;  
OMS 177108 CANADA, INC.
POINTE CLAIRE, QUEBEC,  CA.
OMS MEDICAL SUPPLIES, INC.
WEYMOUTH,  MA,  US.
Initial Importer;  
OMS MEDICAL SUPPLIES, INC.
WEYMOUTH,  MA ,  US.
OMT GMBH
ROTTWEIL-NEUFRA,  GM.
Specification Developer;  
OMT GMBH
ROTTWEIL-NEUFRA,  GM.
OMT, LLC
HOLLYWOOD,  FL,  US.
Specification Developer;  
OMT, LLC
HOLLYWOOD,  FL ,  US.
O'MY PRODUCTS INCORPORATED
NORTH VANCOUVER,  CA.
Foreign Exporter;  
O'MY PRODUCTS INCORPORATED
NORTH VANCOUVER,  CA.
OMYL OPTICAL MFY. LTD.
KWUN TONG, KOWLOON,  HK.
Manufacturer;  
OMYL OPTICAL MFY. LTD.
KWUN TONG, KOWLOON,  HK.
ON FAT PLASTIC FACTORY
TUEN MUN,  HK.
Manufacturer;  
ON FAT PLASTIC FACTORY
TUEN MUN,  HK.
ON SITE GAS SYSTEMS, INC.
NEWINGTON,  CT,  US.
Manufacturer;  
Z-MEDICA CORPORATION
WALLINGFORD,  CT ,  US.
ON STAGE EYEWEAR, INC.
MARLBORO,  MA,  US.
Initial Importer;  
ON STAGE EYEWEAR, INC.
MARLBORO,  MA ,  US.
ON TIME COMPONENTS
GREENFIELD,  IN,  US.
Contract Manufacturer;  
ON TIME COMPONENTS
GREENFIELD,  IN ,  US.
ON TRAXX SOLUTIONS
LOUISVILLE,  KY,  US.
Manufacturer;  
ON TRAXX SOLUTIONS
LOUISVILLE,  KY ,  US.

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Last Modified: 29 April 2006
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