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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
ORALGIENE USA, INC.
CULVER CITY,  CA,  US.
Initial Importer;   Specification Developer;  
ORALGIENE USA, INC.
CULVER CITY,  CA ,  US.
ORALINE, INC.
CORTLAND,  NY,  US.
Initial Importer;  
ORALINE, INC.
CORTLAND,  NY ,  US.
ORALTRONICS
BREMEN,  GM.
Foreign Exporter;   Manufacturer;   Specification Developer;  
SYBRON DENTAL SPECIALTIES, INC.
NEWPORT BEACH,  CA ,  US.
ORALWAVE, LLC
CLAWSON,  MI,  US.
Initial Importer;  
ORALWAVE, LLC
CLAWSON,  MI ,  US.
ORAMAAX DENTAL PRODUCTS,INC.
FREEPORT,  NY,  US.
Manufacturer;   Repackager/Relabeller;  
ORAMAAX DENTAL PRODUCTS,INC.
FREEPORT,  NY ,  US.
ORAMEDIX, INC.
LANCASTER,  CA,  US.
Initial Importer;  
ORAMEDIX, INC.
LANCASTER,  CA ,  US.
ORAMETRIX GMBH
BERLIN,  GM.
Manufacturer;  
ORAMETRIX INC.
RICHARDSON,  TX ,  US.
ORAMETRIX INC.
RICHARDSON,  TX,  US.
Manufacturer;  
ORAMETRIX INC.
RICHARDSON,  TX ,  US.
ORANDA, INC.
ELK GROVE VILLAGE,  IL,  US.
Initial Importer;  
ORANDA, INC.
ELK GROVE VILLAGE,  IL ,  US.
ORANGE COUNTY ASSOCIATION FOR THE HELP OF RETARDE
CAMPBELL HALL,  NY,  US.
Repackager/Relabeller;  
ORANGE COUNTY ASSOCIATION FOR THE HELP OF RETARDE
CAMPBELL HALL,  NY ,  US.
ORANGE-SOL BLENDING & PACKAGING, INC.
GILBERT,  AZ,  US.
Manufacturer;  
THE ORANGE-SOL GROUP OF COMPANIES, LTD.
GILBERT,  AZ ,  US.
ORASURE TECHNOLOGIES INC.
BETHLEHEM,  PA,  US.
Manufacturer;   Specification Developer;  
ORASURE TECHNOLOGIES, INC.
BETHLEHEM,  PA ,  US.
ORASURE TECHNOLOGIES, INC.
BETHLEHEM,  PA,  US.
Manufacturer;   Specification Developer;  
ORASURE TECHNOLOGIES, INC.
BETHLEHEM,  PA ,  US.
ORATEC CORP.
MANASSAS,  VA,  US.
Repackager/Relabeller;  
ORATEC CORP.
MANASSAS,  VA ,  US.
ORATECH, LLC
SOUTH JORDAN,  UT,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ORATECH, LLC
SOUTH JORDAN ',  UT ,  US.
ORATRONICS, INC.
NEW YORK,  NY,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ORATRONICS, INC.
NEW YORK,  NY ,  US.
ORBIS
LOS ANGELES,  CA,  US.
Initial Importer;  
ORBIS
LOS ANGELES,  CA ,  US.
ORBIT MEDICAL, INC.
SALT LAKE CITY,  UT,  US.
Initial Importer;  
ORBIT MEDICAL, INC.
SALT LAKE CITY,  UT ,  US.
ORBIT SURGICAL EQUIPMENT LLC
DECATUR,  GA,  US.
Manufacturer;   Specification Developer;  
ORBIT SURGICAL EQUIPMENT LLC
DECATUR,  GA ,  US.
ORBIT, INC.
OAK RIDGE,  TN,  US.
Manufacturer;  
ORBIT, INC.
OAK RIDGE,  TN ,  US.
ORBITAL ENTERPRISES LLC
SOLON,  OH,  US.
Manufacturer;  
ORBITAL ENTERPRISES LLC
SOLON,  OH ,  US.
ORBUS NEICH MEDICAL (SHENZHEN) CO., LTD.
SHENZHEN, GUANGDONG P.R.O.C.,  CH.
Manufacturer;  
ORBUS NEICH MEDICAL COMPANY, LTD.
WANCHAI,  HK.
ORBUS NEICH MEDICAL, B.V.
HOEVELAKEN,  NL.
Manufacturer;  
ORBUS NEICH MEDICAL COMPANY, LTD.
WANCHAI,  HK.
ORBUS NEICH MEDICAL, INC.
FT. LAUDERDALE,  FL,  US.
Manufacturer;   Specification Developer;  
ORBUS NEICH MEDICAL COMPANY, LTD.
WANCHAI,  HK.
ORC PLASTICS, SILER CITY PLANT
SILER CITY,  NC,  US.
Contract Manufacturer;  
REUNION INDUSTRIES, INC.
PITTSBURGH,  PA ,  US.
ORCHARD INTL. INC.
MISSISSAUGA, ONTARIO,  CA.
Specification Developer;  
ORCHARD INTL. INC.
MISSISSAUGA, ONTARIO,  CA.
ORCHID LATEX MFG.
DURI,  ID.
Manufacturer;  
ORCHID LATEX MFG.
PEKANBARU,  IN.
OREC CORP.
BEAVERTON,  OR,  US.
Specification Developer;   Repackager/Relabeller;  
OREC CORP.
BEAVERTON,  OR ,  US.
OREGON ARTIFICIAL LIMB CO., INC.
PORTLAND,  OR,  US.
Manufacturer;  
OREGON ARTIFICIAL LIMB CO., INC.
PORTLAND,  OR ,  US.
OREGON FREEZE DRY, INC.
ALBANY,  OR,  US.
Contract Manufacturer;  
OREGON FREEZE DRY, INC.
ALBANY,  OR ,  US.
OREGON HEALTH & SCIENCE UNIVERSITY
PORTLAND,  OR,  US.
Specification Developer;  
OREGON HEALTH & SCIENCE UNIVERSITY
PORTLAND,  OR ,  US.
OREGON SCIENTIFIC, INC.
TUALATIN,  OR,  US.
Initial Importer;  
OREGON SCIENTIFIC, INC.
TUALATIN,  OR ,  US.
OREX COMPUTED RADIOGRAPHY LTD
YOKNEAM,  IS.
Manufacturer;   Specification Developer;  
EASTMAN KODAK COMPANY
ROCHESTER,  NY ,  US.
OREX COMPUTED RADIOGRAPHY US, INC.
AUBURNDALE,  MA,  US.
Initial Importer;  
EASTMAN KODAK COMPANY
ROCHESTER,  NY ,  US.
ORFIT INDUSTRIES AMERICA
NEW YORK,  NY,  US.
Initial Importer;  
ORFIT INDUSTRIES NV
WIJNEGEM,  BE.
ORFIT INDUSTRIES NV
WIJNEGEM, ANTWERP,  BE.
Manufacturer;  
ORFIT INDUSTRIES NV
WIJNEGEM,  BE.
ORGAN RECOVERY SYSTEMS, INC.
DES PLAINES,  IL,  US.
Manufacturer;   Specification Developer;  
ORGAN RECOVERY SYSTEMS, INC.
DES PLAINES,  IL ,  US.
ORGANIC LENS MANUFACTURING ESSIDEV S.A.
ENINIS CO. CLARE,  EI.
Manufacturer;  
ESSILOR INTERNATIONAL, S.A.
CHARENTON, CEDEX,  FR.
ORGANIC SPECIALTY CO., INC.
TOWSON,  MD,  US.
Initial Importer;  
ORGANIC SPECIALTY CO., INC.
TOWSON,  MD ,  US.
ORGANOGENESIS, INC.
CANTON,  MA,  US.
Manufacturer;   Specification Developer;  
ORGANOGENESIS, INC.
CANTON,  MA ,  US.

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Last Modified: 29 April 2006
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