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US Food and Drug Administration (FDA) - Orthopedic Devices Registration

FDA Registered Orthopedic Devices - Updated May 2006

What Is Medical Device Listing?

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing.
FDA Devices
FDA Devices
FDA Devices
FDA Devices


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Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MT. SANAI INTL..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   RHEIN ENTERPRISES (PVT) LTD.
Registered Establishment Name:  RHEIN ENTERPRISES (PVT.), LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   YARSONS
Registered Establishment Name:  YARSONS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS ORTHOPEDICS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PAKISTAN SURGICAL INDUSTRIES (PVT) LTD..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PAKISTAN SURGICAL INDUSTRIES (PVT) LTD..
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PAKISTAN SURGICAL INDUSTRIES (PVT) LTD..
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  ASSOCIATED PRODUCTS CO..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  ASSOCIATED PRODUCTS CO..
Classification:   COMPONENT, CAST
Generic Device Name:   DUNFORD
Proprietary Device Name:   DUNFORD
Registered Establishment Name:  PHILIPPINE RADIANT PRODUCTS, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER, WIRE
Proprietary Device Name:   HILBRO WIRE CUTTER
Registered Establishment Name:  HILBRO (PVT) LTD..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC NEEDLE HOLDERS
Proprietary Device Name:   HILBRO ORTHOPEDIC NEEDLE HOLDER
Registered Establishment Name:  HILBRO (PVT) LTD..
Classification:   RONGEUR
Generic Device Name:   VARIOUS MODELS OF RONGEURS
Proprietary Device Name:   HILBRO RONGEUR
Registered Establishment Name:  HILBRO (PVT) LTD..
Classification:   WASHER, BOLT NUT
Generic Device Name:   WASHER, BOLT, NUT
Proprietary Device Name:   OXYGEN NUT & STEM
Registered Establishment Name:  CHEEN HOUNG ENT. CO. LTD..
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   SMALL CYLINDER WRENCH, PLASTIC
Registered Establishment Name:  CHEEN HOUNG ENT. CO. LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  HUAIYIN MEDICAL INSTRUMENTS FACTORY.
Classification:   BIT, DRILL
Generic Device Name:   DRILL TIP
Proprietary Device Name:   AARON DRILL TIP
Registered Establishment Name:  AARON MEDICAL INDUSTRIES.
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   VARIOUS NON-INVASIVE TRACTION COMPONENTS, STERILE AND NON-STERILE
Proprietary Device Name:   MULTIPLE, NON-INVASIVE TRACTION COMPONENTS, SHOULDER SUSPENSIONS
Registered Establishment Name:  DEROYAL SURGICAL - ROSE HILL.
Classification:   SPLINT, TRACTION
Generic Device Name:   TRACTION SPLINT
Proprietary Device Name:   UNIVERSAL BUCKS TRACTION AND OTHER
Registered Establishment Name:  STAT, DIV. DEROYAL INDUSTRIES, INC..
Classification:   COMPONENT, CAST
Generic Device Name:   LINING FABRIC FOR PLASTER CASTS
Proprietary Device Name:   N/A
Registered Establishment Name:  INTERA CORP..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   TRANSDUCER/FETAL MONITOR BELT
Proprietary Device Name:   AEGIS BRAND TRANSDUCER/FETAL MONITOR BELT
Registered Establishment Name:  ELASTIC CORPORATION OF AMERICA.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   COMMON TYPES OF TRACTION CORD
Proprietary Device Name:   TRACTION CORD
Registered Establishment Name:  ORTHOLINE.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS SIZES AND STYLES OF PELVIC TRACTION BELTS
Proprietary Device Name:   PELVIC TRACTION BELT
Registered Establishment Name:  ORTHOLINE.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   BANDAGE SCISSORS/PARAMEDIC SHEARS & NSN 6515-00-935-7138
Proprietary Device Name:   BANDAGE SCISSORS
Registered Establishment Name:  MEDCARE TECHNOLOGIES, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   LATEX FOAM SPLING AND CAST PADDING
Proprietary Device Name:   PROFEX AIRFOAM SPLINT AND CAST PADDING
Registered Establishment Name:  PROFESSIONAL SPECIALTIES CO., INC..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   VARIOUS ARTHROSCOPES AND ACCESSORIES
Registered Establishment Name:  ACMI CORPORATION.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BENOIST GIRARD.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BENOIST GIRARD.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BENOIST GIRARD.
Classification:   CEMENT OBTURATOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BENOIST GIRARD.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BENOIST GIRARD.
Classification:   BROACH
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BENOIST GIRARD.
Classification:   TEMPLATE
Generic Device Name:   TEMPLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BENOIST GIRARD.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   PNEUMATIC ORTHOPEDIC POWER TOOL SYSTEM
Proprietary Device Name:   CHIRODRILL 1200
Registered Establishment Name:  STRYKER TRAUMA GMBH.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   INTRAMEDULLARY NAIL
Proprietary Device Name:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES (MULTIPLE BRANDS)
Registered Establishment Name:  STRYKER TRAUMA GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDICAL MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (MULTIPLE BRANDS)
Registered Establishment Name:  STRYKER TRAUMA GMBH.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   STAPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER TRAUMA GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SCREW
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER TRAUMA GMBH.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   NAIL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER TRAUMA GMBH.
Classification:   TEMPLATE
Generic Device Name:   TEMPLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER TRAUMA GMBH.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATE
Proprietary Device Name:   VARIOUS TYPES
Registered Establishment Name:  BIO-PROT, S.A..

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Last Modified: 29 April 2006
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