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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:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   TRACTION UNIT
Proprietary Device Name:   TRACTION UNIT
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONIOMETER
Proprietary Device Name:   GONIOMETER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   CALIPER
Generic Device Name:   ORTHOPEDIC CALIPER
Proprietary Device Name:   ORTHOPEDIC CALIPER
Registered Establishment Name:  WALDEMAR LINK GMBH & CO. KG.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   ORTOPEDIC SCISSORS
Proprietary Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL
Registered Establishment Name:  MEDICON, E.G..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   DYNAMOMETER
Proprietary Device Name:   DYNAMOMETER, NONPOWERED
Registered Establishment Name:  MEDICON, E.G..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   MICROPROCESSOR -CONTROLLED MICROSURGERY SYSTEM
Proprietary Device Name:   SERVOTRONIC EC100 SYSTEM
Registered Establishment Name:  MEDICON, E.G..
Classification:   FILE
Generic Device Name:   FILE
Proprietary Device Name:   FILE
Registered Establishment Name:  MEDICON, E.G..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  MEDICON, E.G..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Proprietary Device Name:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Registered Establishment Name:  MEDICON, E.G..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   STRIPPER, SURGICAL
Proprietary Device Name:   STRIPPER, SURGICAL
Registered Establishment Name:  MEDICON, E.G..
Classification:   SPLINT, TRACTION
Generic Device Name:   SPLINT, TRACTION
Proprietary Device Name:   SPLINT, TRACTION
Registered Establishment Name:  MEDICON, E.G..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SCREW, FIXATION, BONE
Proprietary Device Name:   SCREW, FIXATION, BONE
Registered Establishment Name:  MEDICON, E.G..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   SCREWDRIVER
Registered Establishment Name:  MEDICON, E.G..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   NAIL, FIXATION, BONE
Proprietary Device Name:   NAIL, FIXATION, BONE
Registered Establishment Name:  MEDICON, E.G..
Classification:   BENDER
Generic Device Name:   BENDER
Proprietary Device Name:   BENDER
Registered Establishment Name:  MEDICON, E.G..
Classification:   WRENCH
Generic Device Name:   WRECH, ORTHOPEDIC
Proprietary Device Name:   WRECH, ORTHOPEDIC
Registered Establishment Name:  MEDICON, E.G..
Classification:   TWISTER, WIRE
Generic Device Name:   TWISTER, WIRE
Proprietary Device Name:   TWISTER, WIRE
Registered Establishment Name:  MEDICON, E.G..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   AWL
Registered Establishment Name:  MEDICON, E.G..
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   DRIVER
Proprietary Device Name:   DRIVER, PROSTHESIS
Registered Establishment Name:  MEDICON, E.G..
Classification:   SKID, BONE
Generic Device Name:   BONE SKID
Proprietary Device Name:   SKID, BONE
Registered Establishment Name:  MEDICON, E.G..
Classification:   BRACE, DRILL
Generic Device Name:   BRACE, DRILL
Proprietary Device Name:   BRACE, DRILL
Registered Establishment Name:  MEDICON, E.G..
Classification:   TAMP
Generic Device Name:   TAMP
Proprietary Device Name:   TAMP
Registered Establishment Name:  MEDICON, E.G..
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER, WIRE
Proprietary Device Name:   CUTTER, WIRE
Registered Establishment Name:  MEDICON, E.G..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   KNIFE, ORTHOPEDIC
Proprietary Device Name:   KNIFE, ORTHOPEDIC
Registered Establishment Name:  MEDICON, E.G..
Classification:   PASSER
Generic Device Name:   TENDON PASSER
Proprietary Device Name:   PASSER
Registered Establishment Name:  MEDICON, E.G..
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   WIRE PASSER
Proprietary Device Name:   PASSER, WIRE, ORTHOPEDIC
Registered Establishment Name:  MEDICON, E.G..
Classification:   RONGEUR
Generic Device Name:   BONE RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  MEDICON, E.G..
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   REAMER
Registered Establishment Name:  MEDICON, E.G..
Classification:   BRACE, DRILL
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  MEDITRAC MEDICAL EQUIPMENT.
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   IDOPATHIC SCOLIOSIS TREATMENT RAIL ATTACHMENT
Proprietary Device Name:   D.B.S. (DYNAMIC BRACE SYSTEM)
Registered Establishment Name:  MEDITRAC MEDICAL EQUIPMENT.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   VERTETRAC CERVICO 2000
Registered Establishment Name:  MEDITRAC MEDICAL EQUIPMENT.
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS MODELS OF ARTHROSCOPES AND ACCESSORIES
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  KARL STORZ ENDOSCOPY-AMERICA, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS BONE FIXATION SCREWS
Proprietary Device Name:   KARL STORZ FIXATION SCREW
Registered Establishment Name:  KARL STORZ ENDOSCOPY-AMERICA, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   ARTHROSCOPY SHAVER SYSTEM
Proprietary Device Name:   KARL STORZ MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
Registered Establishment Name:  KARL STORZ ENDOSCOPY-AMERICA, INC..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF FINGER NAIL DRILLS
Proprietary Device Name:   FINGER NAIL DRILL
Registered Establishment Name:  BAUR UND HASELBARTH-CHIRURG GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER FOR IMPLANTS
Proprietary Device Name:   WIRE & PIN CUTTER
Registered Establishment Name:  BAUR UND HASELBARTH-CHIRURG GMBH.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   VARIOUS MODELS OF DYNAMOMETER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF BUCK GMBH.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS SIZES OF BURRS, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF BUCK GMBH.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS MODELS OF DRILLS, SURGICAL, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF BUCK GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS MODELS OF RONGEURS, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF BUCK GMBH.

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Last Modified: 29 April 2006
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