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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
ORGANON, INC.
ALLENTOWN,  PA,  US.

ORGANON USA INC.
WEST ORANGE,  NJ ,  US.
ORGENICS LTD.
YAVNE,  IS.
Manufacturer;  
ORGENICS LTD.
YAVNE,  IS.
ORGENTEC DIAGNOSTIKA GMBH
MAINZ,  GM.
Manufacturer;  
ORGENTEC DIAGNOSTIKA GMBH
MAINZ,  GM.
ORGREEN OPTICS APS.
COPENHAGEN,  DA.
Foreign Exporter;   Manufacturer;  
ORGREEN OPTICS APS.
COPENHAGEN,  DA.
ORI NATURE INT'L., INC.
NEW YORK,  NY,  US.
Initial Importer;  
ORI NATURE INT'L., INC.
NEW YORK,  NY ,  US.
ORIAM
SAINT MAUR, CEDEX,  FR.
Unregistered Foreign Lister;  
ORIAM
SAINT MAUR, CEDEX,  FR.
ORIDION BREATH ID, INC.
NEEDHAM,  MA,  US.
Initial Importer;  
ORIDION MEDICAL 1987 LTD.
JERUSALEM,  IS.
ORIDION CAPNOGRAPHY, INC.
NEEDHAM,  MA,  US.
Initial Importer;  
ORIDION MEDICAL 1987 LTD.
JERUSALEM,  IS.
ORIDION MEDICAL 1987 LTD.
JERUSALEM,  IS.
Manufacturer;  
ORIDION MEDICAL 1987 LTD.
JERUSALEM,  IS.
ORIENT INTERNATIONAL BUSINESS
SHANGHAI,  CH.
Manufacturer;  
ORIENT INTERNATIONAL BUSINESS
SHANGHAI,  CH.
ORIENTAL INSPIRATION LTD
HONG KONG,  CH.
Manufacturer;  
ORIENTAL INSPIRATION LTD
HONG KONG,  CH.
ORIENTAL INTERNATIONAL SUPPLIES LIMITED
KOWLOON,  HK.
Foreign Exporter;  
ORIENTAL INTERNATIONAL SUPPLIES LIMITED
KOWLOON,  HK.
ORIENTAL OPTIONS
SOUTHFIELD,  MI,  US.
Initial Importer;  
ORIENTAL OPTIONS
SOUTHFIELD,  MI ,  US.
ORIENTAL SCIENTIFIC INSTRUMENTS IMPORT & EXPORT
SHANGHAI,  CH.
Unregistered Foreign Lister;  
ORIENTAL SCIENTIFIC INSTRUMENTS IMPORT & EXPORT
SHANGHAI,  CH.
ORIENTAL SYSTEM TECHNOLOGY, INC.
GUANG DONG, MAINLAND,  CH.
Manufacturer;  
ORIENTAL SYSTEM TECHNOLOGY, INC.
HSINCHU, TAIWAN,  CH.
ORIENTAL SYSTEM TECHNOLOGY, INC.
HSINCHU,  TW.
Manufacturer;  
ORIENTAL SYSTEM TECHNOLOGY, INC.
HSINCHU,  TW.
ORIENTAL TRADING CO.
OMAHA,  NE,  US.
Initial Importer;  
ORIENTAL TRADING CO.
OMAHA,  NE ,  US.
ORIFICE MEDICAL AB
YSTAD,  SW.
Manufacturer;  
ORIFICE MEDICAL AB
YSTAD,  SW.
ORIGEN BIOMEDICAL, INC.
AUSTIN,  TX,  US.
Manufacturer;   Specification Developer;  
ORIGEN BIOMEDICAL, INC.
AUSTIN,  TX ,  US.
ORIGHT CO.
CHUNBUK,  KS.
Unregistered Foreign Lister;  
ORIGHT CO.
CHUNBUK,  KS.
ORIGO KLEBE TECHNIK CO., LTD.
TAIPEI,  TW.
Unregistered Foreign Lister;  
ORIGO KLEBE TECHNIK CO., LTD.
TAIPEI,  TW.
ORIMAR DENTAL PRODUCTS CORP.
MIAMI,  FL,  US.
Initial Importer;  
ORIMAR DENTAL PRODUCTS CORP.
MIAMI,  FL ,  US.
ORION CONCEPTS
ROYAL OAK,  MI,  US.
Initial Importer;  
ORION CONCEPTS
LASALLE ON.,  CA.
ORION DIAGNOSTICA OY
ESPOO,  FI.
Manufacturer;  
ORION DIAGNOSTICA OY
ESPOO,  FI.
ORION DIAGNOSTICA OY
TURKU,  FI.
Manufacturer;  
ORION DIAGNOSTICA OY
ESPOO,  FI.
ORION ENTERPRISES INC.
NORTHBROOK,  IL,  US.
Initial Importer;  
ORION ENTERPRISES INC.
NORTHBROOK,  IL ,  US.
ORION LIFE SYSTEMS, INC.
WHEELING,  IL,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
ORION LIFE SYSTEMS, INC.
WHEELING,  IL ,  US.
ORION MEDICAL GROUP
RENO,  NV,  US.
Initial Importer;   Specification Developer;  
ORION MEDICAL GROUP
RENO,  NV ,  US.
ORION PROGRESSIVE LENS LAB, INC.
MADISON,  WI,  US.
Initial Importer;  
ORION PROGRESSIVE LENS LAB, INC.
MAPLE BLUFF,  WI ,  US.
ORIOXI INTL. CORP.
WALNUT,  CA,  US.
Initial Importer;  
ORIOXI INTL. CORP.
WALNUT,  CA ,  US.
O-RIVER CO., LTD.
KUEI-JEN, TAINAN,  TW.
Manufacturer;  
O-RIVER CO., LTD.
KUEI-JEN, TAINAN,  TW.
ORLIMAN S.L.
CATARROJA,  SP.
Unregistered Foreign Lister;  
ORLIMAN S.L.
CATARROJA,  SP.
ORMCO CORP.
GLENDORA,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
SYBRON DENTAL SPECIALTIES, INC.
NEWPORT BEACH,  CA ,  US.
ORMCO CORP.
SAN DIMAS,  CA,  US.
Manufacturer;   Repackager/Relabeller;  
SYBRON DENTAL SPECIALTIES, INC.
NEWPORT BEACH,  CA ,  US.
ORMESA S.R.L.
FOLIGNO (PG),  IT.
Manufacturer;  
ORMESA S.R.L.
FOLIGNO (PG),  IT.
ORMEX, S.A. DE C.V.
YUCATAN UMAN,  MX.
Contract Manufacturer;  
SYBRON DENTAL SPECIALTIES, INC.
NEWPORT BEACH,  CA ,  US.
ORMIHL
VILLEURBANNE,  FR.
Manufacturer;  
ORMIHL
VILLEURBANNE,  FR.
ORNELAS ENTERPRISES, INC.
HILLSBORO,  OR,  US.
Contract Manufacturer;  
ORNELAS ENTERPRISES, INC.
HILLSBORO,  OR ,  US.
OR-PRO MEDICAL, INC.
SAN JUAN,  PR,  US.
Initial Importer;  
OR-PRO MEDICAL, INC.
SAN JUAN,  PR ,  US.
ORQIS MEDICAL CORPORATION
LAKE FOREST,  CA,  US.
Specification Developer;  
ORQIS MEDICAL CORPORATION
LAKE FOREST,  CA ,  US.

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Last Modified: 29 April 2006
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