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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
ONBO ELECTRONIC (SHENZHEN) CO. LTD.
SHENZHEN,  CH.
Manufacturer;   Specification Developer;  
MICROLIFE CORP.
TAIPEI,  TW.
ONCODIAGNOSTIC LABORATORY, INC.
CLEVELAND,  OH,  US.
Specification Developer;   Repackager/Relabeller;  
ONCODIAGNOSTIC LABORATORY, INC.
CLEVELAND,  OH ,  US.
ONCOGENE SCIENCE/BAYER HEALTHCARE LLC
CAMBRIDGE,  MA,  US.
Manufacturer;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
ONCOLOGY AUTOMATION, INC.
LAFAYETTE,  LA,  US.
Manufacturer;  
ONCOLOGY AUTOMATION, INC.
LAFAYETTE,  LA ,  US.
ONCOPROBE BIOTECH INC.
WUGU SHIANG, TAIPEI COUNTY,  TW.
Manufacturer;  
ONCOPROBE BIOTECH INC.
KAOHSIUNG,  TW.
ONCOTECH, INC.
TUSTIN,  CA,  US.
Specification Developer;  
ONCOTECH, INC.
TUSTIN,  CA ,  US.
ONCURA INC.
PLYMOUTH MEETING,  PA,  US.
Initial Importer;   Repackager/Relabeller;  
ONCURA INC.
PLYMOUTH MEETING,  PA ,  US.
ONDAMED, INC.
NEW WINDSOR,  NY,  US.
Initial Importer;  
BINDER GMBH
TUTTLINGEN,  GM.
ONDO PHARMACEUTICAL CO., INC.
PALM BEACH,  FL,  US.
Initial Importer;   Contract Manufacturer;   Contract Sterilizer;   Repackager/Relabeller;  
ONDO PHARMACEUTICAL CO., INC.
PALM BEACH,  FL ,  US.
ONE DENTAL SUPPLIES INC.
BROOKLYN,  NY,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ONE DENTAL SUPPLIES INC.
BROOKLYN,  NY ,  US.
ONE DROP ONLY GMBH
BERLIN,  GM.
Manufacturer;  
ONE DROP ONLY GMBH
BERLIN,  GM.
ONE LAMBDA, INC.
CANOGA PARK,  CA,  US.
Manufacturer;  
ONE LAMBDA, INC.
CANOGA PARK,  CA ,  US.
ONE POINT ENTERPRISES, INC.
SAN GABRIEL,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
ONE POINT ENTERPRISES, INC.
SAN GABRIEL,  CA ,  US.
ONE PRICE CLOTHING STORES, INC.
DUNCAN,  SC,  US.
Initial Importer;  
ONE PRICE CLOTHING STORES, INC.
DUNCAN,  SC ,  US.
ONE TEN SURGICAL & DENTAL MFG. CO.
SIALKOT, PUNJAB,  PK.
Manufacturer;  
ONE TEN SURGICAL & DENTAL MFG. CO.
SIALKOT, PUNJAB,  PK.
ONE TOUCH PRODUCTS CO., LTD.
TAINAN, TAINAN,  TW.
Manufacturer;  
ONE TOUCH PRODUCTS CO., LTD.
TAINAN, TAINAN,  TW.
ONE WORLD DISTRIBUTION, INC.
OAKLAND,  CA,  US.
Initial Importer;  
ONE WORLD DISTRIBUTION, INC.
OAKLAND,  CA ,  US.
ONE WORLD TRADING
SAN FRANCISCO,  CA,  US.
Initial Importer;  
ONE WORLD TRADING
SAN FRANCISCO,  CA ,  US.
ONE ZONE DEVICES
SAN DIEGO,  CA,  US.
Contract Manufacturer;   Manufacturer;  
ONE ZONE DEVICES
SAN DIEGO,  CA ,  US.
ONEG HAKARMEL LTD.
HAIFA,  IS.
Manufacturer;  
ONEG HAKARMEL LTD.
HAIFA,  IS.
ONEWORLD ENTERPRISES LTD.
KOWLOON BAY,  HK.
Repackager/Relabeller;  
ONEWORLD ENTERPRISES LTD.
KOWLOON BAY,  HK.
ONGOING CARE SOLUTIONS, INC.
PINELLAS PARK,  FL,  US.
Manufacturer;  
ONGOING CARE SOLUTIONS, INC.
PINELLAS PARK,  FL ,  US.
ONGPIN ENTERPRISES CO., LTD.
SHENZHEN,  CH.
Manufacturer;  
ONGPIN INTL., INC.
NEI-HU, TAIPEI,  TW.
ON-GUARD SAFETY CORP.
CONCORD, ONTARIO,  CA.
Specification Developer;  
ON-GUARD SAFETY CORP.
CONCORD, ONTARIO,  CA.
ONI MEDICAL SYSTEMS, INC.
WILMINGTON,  MA,  US.
Manufacturer;  
ONI MEDICAL SYSTEMS, INC.
WILMINGTON,  MA ,  US.
ONKEL
SAARBRUCKEN, SARRE,  GM.
Manufacturer;  
ONKEL
SAARBRUCKEN, SARRE,  GM.
ONLINE VENTURE
SETAPAK KUALA LUMPUR,  MY.
Remanufacturer;  
ONLINE VENTURE
SETAPAK KUALA LUMPUR,  MY.
ONNURY OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
ONNURY OPTICAL CO.
DAEGU,  KS.
ONO'S TRADING COMPANY, LLC
MOBILE,  AL,  US.
Specification Developer;  
ONO'S TRADING COMPANY, LLC
MOBILE,  AL ,  US.
ONSET MEDICAL CORPORATION
IRVINE,  CA,  US.
Manufacturer;  
ONSET MEDICAL CORPORATION
IRVINE,  CA ,  US.
ONSHORE TECHNOLOGIES, INC.
TORRANCE,  CA,  US.
Contract Manufacturer;  
ONSHORE TECHNOLOGIES, INC.
TORRANCE,  CA ,  US.
ONSIGHT OPTICAL
HOWELL,  NJ,  US.
Initial Importer;  
ONSIGHT OPTICAL
HOWELL,  NJ ,  US.
ONTEL PRODUCTS CORP.
FAIRFIELD,  NJ,  US.
Initial Importer;  
ONTEL PRODUCTS CORP.
FAIRFIELD,  NJ ,  US.
ONTEX EUTIMA
EEKLO,  BE.
Contract Manufacturer;  
ONTEX
BUGGENHOUT,  BE.
ONTEX HEALTHCARE FRANCE SA
LUNEL-VIEL,  FR.
Contract Manufacturer;  
ONTEX
BUGGENHOUT,  BE.
ONTEX HYGIENEARTIKEL GMBH
GROSSPOSTWITZ,  GM.
Contract Manufacturer;  
ONTEX
BUGGENHOUT,  BE.
ONTEX NV
BUGGENHOUT,  BE.
Contract Manufacturer;  
ONTEX
BUGGENHOUT,  BE.
ONTEX PENINSULAR S.A.
SEGOVIA,  SP.
Contract Manufacturer;  
ONTEX
BUGGENHOUT,  BE.
ONYX INDUSTRIES, INC./QUADRTECH
GARDENA,  CA,  US.
Manufacturer;  
ONYX INDUSTRIES, INC./QUADRTECH
GARDENA,  CA ,  US.
ONYX INTL. CO.
ROUSES POINT,  NY,  US.
Initial Importer;  
ONYX INTL. CO.
DOLLARD DES ORMEAUX,  CA.

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Last Modified: 29 April 2006
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