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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
ORTHODONTIC TECHNOLOGIES, INC.
HOUSTON,  TX,  US.
Contract Manufacturer;  
ORTHODONTIC TECHNOLOGIES, INC.
HOUSTON,  TX ,  US.
ORTHODONTIST, SUHAIL A. KHOURI DDS, P.C
CHESTERFIELD,  MO,  US.
Initial Importer;   Specification Developer;  
ORTHODONTIST, SUHAIL A. KHOURI DDS, P.C
CHESTERFIELD,  MO ,  US.
ORTHO-DYNAMIC GMBH
REMSCHEID,  GM.
Unregistered Foreign Lister;  
ORTHO-DYNAMIC GMBH
REMSCHEID,  GM.
ORTHOEAST, INC.
GORHAM,  ME,  US.

ORTHOEAST, INC.
GORHAM,  ME ,  US.
ORTHOFAB, INC.
QUEBEC CITY, QUEBEC,  CA.
Manufacturer;  
ORTHOFAB, INC.
QUEBEC, QUEBEC,  CA.
ORTHOFEET, INC.
NORTHVALE,  NJ,  US.
Manufacturer;  
ORTHOFEET, INC.
NORTHVALE,  NJ ,  US.
ORTHOFIL SARL
PULLY,  SZ.
Specification Developer;  
ORTHOFIL SARL
PULLY,  SZ.
ORTHOFIX INC.
MCKINNEY,  TX,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
ORTHOFIX INC.
MCKINNEY,  TX ,  US.
ORTHOFIX SRL
BUSSOLENGO (VR),  IT.
Manufacturer;  
ORTHOFIX SRL
BUSSOLENGO (VR),  IT.
ORTHOGAP, INC.
TAMPA,  FL,  US.
Specification Developer;   Repackager/Relabeller;  
ORTHOGAP, INC.
TAMPA,  FL ,  US.
ORTHOGEN CORP.
SPRINGFIELD,  NJ,  US.
Initial Importer;  
ORTHOGEN CORP.
SPRINGFIELD,  NJ ,  US.
ORTHOGEN THERAPEUTICS GMBH
DUSSELDORF,  GM.
Foreign Exporter;   Manufacturer;   Specification Developer;  
ORTHOGEN THERAPEUTICS GMBH
DUSSELDORF,  GM.
ORTHOGENESIS, INC.
EL DORADO HILLS,  CA,  US.
Manufacturer;   Specification Developer;  
ORTHOGENESIS, INC.
EL DORADO HILLS,  CA ,  US.
ORTHOHELIX SURGICAL DESIGNS, INC.
AKRON,  OH,  US.
Manufacturer;   Specification Developer;  
ORTHOHELIX SURGICAL DESIGNS, INC.
AKRON,  OH ,  US.
ORTHOLINE
NORWALK,  CT,  US.
Repackager/Relabeller;  
MARPAH, INC.
WESTON,  CT ,  US.
ORTHOLUTION CO., LTD.
SEOUL,  KS.
Manufacturer;  
ORTHOLUTION CO., LTD.
SEOUL,  KS.
ORTHO-MCNEIL PHARMACEUTICAL, INC.
BRIDGEWATER,  NJ,  US.

ORTHO-MCNEIL PHARMACEUTICAL, INC.
RARITAN,  NJ ,  US.
ORTHO-MCNEIL PHARMACEUTICAL, INC.
RARITAN,  NJ,  US.
Manufacturer;   Specification Developer;  
ORTHO-MCNEIL PHARMACEUTICAL, INC.
RARITAN,  NJ ,  US.
ORTHO-MCNEIL PHARMACEUTICAL, INC.
SOMERSET,  NJ,  US.

ORTHO-MCNEIL PHARMACEUTICAL, INC.
RARITAN,  NJ ,  US.
ORTHOMECHANICS, L.C.
BROKEN ARROW,  OK,  US.
Initial Importer;   Repackager/Relabeller;  
ORTHOMECHANICS, L.C.
BROKEN ARROW,  OK ,  US.
ORTHO-MED (SUPPLIES) LTD.
LONDON,  UK.
Unregistered Foreign Lister;  
ORTHO-MED (SUPPLIES) LTD.
LONDON,  UK.
ORTHO-MED INTL., INC.
CALEXICO,  CA,  US.
Initial Importer;   Manufacturer;  
ORTHO-MED INTL., INC.
CALEXICO,  CA ,  US.
ORTHO-MED, INC.
PORTLAND,  OR,  US.
Initial Importer;  
ORTHO-MED, INC.
PORTLAND,  OR ,  US.
ORTHOMEDIX, INC.
SAN DIEGO,  CA,  US.
Initial Importer;  
ORTHOMEDIX, INC.
SAN DIEGO,  CA ,  US.
ORTHOMERICA PRODUCTS, INC.
ORLANDO,  FL,  US.
Manufacturer;  
ORTHOMERICA PRODUCTS, INC.
ORLANDO,  FL ,  US.
ORTHOMETRICS, INC.
MANSFIELD,  MA,  US.
Specification Developer;  
ORTHOMETRICS, INC.
MANSFIELD,  MA ,  US.
ORTHOMETRIX, INC.
WHITE PLAINS,  NY,  US.
Initial Importer;   Specification Developer;  
ORTHOMETRIX, INC.
WHITE PLAINS,  NY ,  US.
ORTHONETX, INC.
SUPERIOR,  CO,  US.
Manufacturer;   Specification Developer;  
ORTHONETX, INC.
SUPERIOR,  CO ,  US.
ORTHONEUTROGENA
LOS ANGELES,  CA,  US.
Initial Importer;  
ORTHONEUTROGENA
LOS ANGELES,  CA ,  US.
ORTHOPAEDIC DESIGNS, INC.
CHARLOTTESVILLE,  VA,  US.
Specification Developer;  
ORTHOPAEDIC DESIGNS, INC.
CHARLOTTESVILLE,  VA ,  US.
ORTHOPAEDIC DEVELOPMENT, LLC
WELLINGTON,  FL,  US.
Manufacturer;  
ORTHOPAEDIC DEVELOPMENT, LLC
WELLINGTON,  FL ,  US.
ORTHOPAEDIC MARKETING CONSULTANTS, INC
MIAMI,  FL,  US.
Initial Importer;  
ORTHOPAEDIC MARKETING CONSULTANTS, INC
MIAMI,  FL ,  US.
ORTHOPEDIC ALLIANCE LLC
MURRIETA,  CA,  US.
Initial Importer;   Specification Developer;  
ORTHOPEDIC ALLIANCE LLC
MURRIETA,  CA ,  US.
ORTHOPEDIC DESIGNS, INC.
ST. PETERSBURG,  FL,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ORTHOPEDIC DESIGNS, INC.
ST. PETERSBURG,  FL ,  US.
ORTHOPEDIC DIST.
BUFFALO,  NY,  US.
Initial Importer;   Repackager/Relabeller;  
ORTHOPEDIC DIST.
BUFFALO,  NY ,  US.
ORTHOPEDIC INNOVATIVE TECHNOLOGY, LLC
MANTECA,  CA,  US.
Manufacturer;  
ORTHOPEDIC INNOVATIVE TECHNOLOGY, LLC
MANTECA,  CA ,  US.
ORTHOPEDIC SCIENCES, INC
SEAL BEACH,  CA,  US.
Manufacturer;   Specification Developer;  
ORTHOPEDIC SCIENCES, INC
SEAL BEACH,  CA ,  US.
ORTHOPEDIC SERVICES OF R.I.
PROVIDENCE,  RI,  US.
Manufacturer;  
ORTHOPEDIC SERVICES OF R.I.
PROVIDENCE,  RI ,  US.
ORTHOPEDIC SOLUTIONS, INC.
FT LAUDERDALE,  FL,  US.
Specification Developer;  
ORTHOPEDIC SOLUTIONS, INC.
FT LAUDERDALE,  FL ,  US.
ORTHOPEDIC SYSTEMS, INC.
UNION CITY,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ORTHOPEDIC SYSTEMS, INC.
UNION CITY,  CA ,  US.

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Last Modified: 29 April 2006
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