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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
ORTHOPLI CORP.
PHILADELPHIA,  PA,  US.
Manufacturer;  
ORTHOPLI CORP.
PHILADELPHIA,  PA ,  US.
ORTHOPOD, INC.
WEST LOS ANGELES,  CA,  US.
Manufacturer;  
ORTHOPOD, INC.
WEST LOS ANGELES,  CA ,  US.
ORTHOPOST S.R.L.
SEGRATE MILANO,  IT.
Manufacturer;  
ORTHOPOST S.R.L.
SEGRATE MI,  IT.
ORTHOPRO LLC
SALT LAKE CITY,  UT,  US.
Initial Importer;   Specification Developer;  
ORTHOPRO LLC
SALT LAKE CITY,  UT ,  US.
ORTHOQUEST, L.L.C.
LUBBOCK,  TX,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ORTHOQUEST, L.L.C.
LUBBOCK,  TX ,  US.
ORTHOREHAB
PICKERING, ONTARIO,  CA.
Manufacturer;  
OTTO BOCK HEALTHCARE, GMBH
DUDERSTADT,  GM.
ORTHORITY CORPORATION
CAGUAS,  PR,  US.
Initial Importer;  
ORTHORITY CORPORATION
CAGUAS,  PR ,  US.
ORTHORX, INC.
SAN DIEGO,  CA,  US.
Manufacturer;  
ORTHORX, INC.
SAN DIEGO,  CA ,  US.
ORTHOS (UK) LIMITED
BRISTOL NORTH SOMERSET,  UK.
Foreign Exporter;   Manufacturer;   Specification Developer;  
ORTHOS (UK) LIMITED
BRISTOL NORTH SOMERSET,  UK.
ORTHOSCAN LTD.
ROSH-PINA,  IS.
Manufacturer;  
ORTHOSCAN LTD.
ROSH-PINA,  IS.
ORTHOSCAN, INC.
SCOTTSDALE,  AZ,  US.
Manufacturer;   Specification Developer;  
ORTHOSCAN, INC.
SCOTTSDALE,  AZ ,  US.
ORTHOSERVICE AG
STANSSTAD,  SZ.
Foreign Exporter;  
ORTHOSERVICE AG
STANSSTAD,  SZ.
ORTHOSOFT
KIEV,  UP.
Manufacturer;  
ORTHOSOFT
KIEV,  UP.
ORTHOSOFT, INC.
MONTREAL, QUEBEC,  CA.
Manufacturer;  
ORTHOSOFT, INC.
MONTREAL, QUEBEC,  CA.
ORTHOSOFT, INC.
MONTREAL, QUEBEC,  CA.
Foreign Exporter;   Manufacturer;  
ORTHOSOFT, INC.
MONTREAL, QUEBEC,  CA.
ORTHOSONICS, INC.
WOODSTOCK,  GA,  US.
Initial Importer;  
ORTHOSONICS, INC.
WOODSTOCK,  GA ,  US.
ORTHOSONICS, LTD.
FLORHAM,  NJ,  US.
Initial Importer;  
ORTHOFIX INC.
MCKINNEY,  TX ,  US.
ORTHOSOURCE, INC.
NORTH HOLLYWOOD,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ORTHOSOURCE
NORTH HOLLYWOOD,  CA ,  US.
ORTHOSOURCE, INC.
PACIFIC PALISADES,  CA,  US.
Repackager/Relabeller;  
ORTHOSOURCE, INC.
PACIFIC PALISADES,  CA ,  US.
ORTHOSTAR LLC
MCLEAN,  VA,  US.
Initial Importer;   Manufacturer;  
ORTHOSTAR LLC
MCLEAN,  VA ,  US.
ORTHOSURGICAL IMPLANTS, INC.
MIAMI,  FL,  US.
Initial Importer;  
ORTHOSURGICAL IMPLANTS, INC.
MIAMI,  FL ,  US.
ORTHO-TAIN, INC.
TOA ALTA,  PR,  US.
Initial Importer;   Manufacturer;  
ORTHO-TAIN, INC.
TOA ALTA,  PR ,  US.
ORTHOTEC, L.L.C.
BEVERLY HILLS,  CA,  US.
Initial Importer;   Specification Developer;  
ORTHOTEC, L.L.C.
BEVERLY HILLS,  CA ,  US.
ORTHO-TEX, INC.
SAN ANTONIO,  TX,  US.
Specification Developer;   Repackager/Relabeller;  
ORTHO-TEX, INC.
SAN ANTONIO,  TX ,  US.
ORTHOTIC & PROSTHETIC LAB, INC.
WEBSTER GROVES,  MO,  US.
Manufacturer;  
ORTHOTIC & PROSTHETIC LAB, INC.
WEBSTER GROVES,  MO ,  US.
ORTHOTIC MOBILITY SYSTEMS, INC.
KENSINGTON,  MD,  US.
Manufacturer;  
ORTHOTIC MOBILITY SYSTEMS, INC.
KENSINGTON,  MD ,  US.
ORTHOTIC PROSTHETIC CENTER, INC.
FAIRFAX,  VA,  US.
Initial Importer;  
ORTHOTIC PROSTHETIC CENTER, INC.
FAIRFAX,  VA ,  US.
ORTHOTIC REHABILITATION PRODUCTS, INC.
TAMPA,  FL,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ORTHOTIC REHABILITATION PRODUCTS, INC.
TAMPA,  FL ,  US.
ORTHOTIC SOLUTIONS, LLC.
FAIRFAX,  VA,  US.
Manufacturer;  
LUKE STIKELEATHER, CO.
FAIRFAX,  VA ,  US.
ORTHOTICS & PROSTHETICS REHAB. ENGIN. CTR., INC.
WARREN,  OH,  US.
Initial Importer;  
ORTHOTICS & PROSTHETICS REHAB. ENGIN. CTR., INC.
WARREN,  OH ,  US.
ORTHOTICS AND PROSTHETICS ONE, INC.
WATERLOO,  IA,  US.
Initial Importer;  
ORTHOTICS AND PROSTHETICS ONE, INC.
WATERLOO,  IA ,  US.
ORTHOTON B.V.
GORINCHEM, ZH,  NL.
Manufacturer;  
ORTHOTON B.V.
GORINCHEM, ZH,  NL.
ORTHO-VACON, INC.
RACINE,  WI,  US.
Manufacturer;  
ORTHO-VACON, INC.
RACINE,  WI ,  US.
ORTHOVISAGE, INC.
CATSKILL,  NY,  US.
Specification Developer;  
ORTHOVISAGE, INC.
CATSKILL,  NY ,  US.
ORTHOVITA, INC.
MALVERN,  PA,  US.
Manufacturer;   Specification Developer;  
ORTHOVITA, INC.
MALVERN,  PA ,  US.
ORTHOXPAND INTERNATIONAL, INC.
LAKVILLE,  IN,  US.
Specification Developer;  
ORTHOXPAND INTERNATIONAL, INC.
LAKVILLE,  IN ,  US.
ORTIVUS AB
TABY,  SW.
Manufacturer;  
ORTIVUS AB
TABY,  SW.
ORTIVUS US
HOLICONG,  PA,  US.
Initial Importer;  
ORTIVUS AB
TABY,  SW.
ORTIVUS US, INC.
HOLICONG,  PA,  US.
Initial Importer;  
ORTIVUS AB
TABY,  SW.
ORTO 2000 VERTRIEBS GMBH
BERLIN,  GM.
Unregistered Foreign Lister;  
ORTO 2000 VERTRIEBS GMBH
BERLIN,  GM.

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Last Modified: 29 April 2006
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