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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:   BENDER
Generic Device Name:   VARIOUS TYPES OF BENDER
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  MEDI PLUS INSTRUMENTE GMBH & CO. KG.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SAME
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   STRIPPER, SURGICAL
Proprietary Device Name:   STRIPPER, SURGICAL
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS TYPES OF ARTHROSCOPE
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF WASHERS (SEALES) BOLTS, NUTS
Proprietary Device Name:   TEKNO
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   BIT, DRILL
Generic Device Name:   BIT, DRILL
Proprietary Device Name:   BIT, DRILL
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   BRACE, DRILL
Generic Device Name:   DRILL, ORTHOPAEDIC
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF CUTTER, WIRE, ORTHOPEDIC
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   STAPLE, FIXATION, BONE
Proprietary Device Name:   STAPLE, FIXATION, BONE
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   BONE NAIL
Proprietary Device Name:   KUNTSCHER BONE
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   REAMER
Generic Device Name:   ORTHOPEDIC REAMER
Proprietary Device Name:   REAMER
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   PLATE, FIXATION, BONE
Proprietary Device Name:   PLATE, FIXATION, BONE
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE TWISTER
Proprietary Device Name:   TEKNO
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR
Proprietary Device Name:   TEKNO
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   TEKNO
Proprietary Device Name:   TEKNO
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   TEKNO
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   WIRE, SURGICAL
Generic Device Name:   TEKNO
Proprietary Device Name:   TEKNO
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   IMPACTOR
Generic Device Name:   TEKNO
Proprietary Device Name:   TEKNO
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   TEKNO
Proprietary Device Name:   TEKNO
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Proprietary Device Name:   TEKNO
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEUR
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   STARTER, BONE SCREW
Generic Device Name:   VARIOUS TYPES OF BONE SCREW STARTERS
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGUERS, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HERMANN BRUGGER.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   KNIFE, ORTHOPEDIC
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  FUCHS INSTRUMENTE.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC FORCEPS
Proprietary Device Name:   ORTHOPEDIC FORCEPS (VARIOUS MODELS)
Registered Establishment Name:  FUCHS INSTRUMENTE.
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS MODELS OF WASHER, BOLT, NUT, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   AWL
Generic Device Name:   VARIOUS MODELS OF AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS MODELS OF SCREWS FIXATION BONE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   SKID, BONE
Generic Device Name:   VARIOUS MODELS OF SKIDS, BONES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   VARIOUS MODELS OF STAPLES,FIXATION, BONE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   STARTER, BONE SCREW
Generic Device Name:   VARIOUS MODELS OF STARTERS, BONES SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   TAP, BONE
Generic Device Name:   VARIOUS MODELS OF TAPS,BONE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS MODELS OF BRACES,DRILLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS MODELS OF OF INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   VARIOUS MODELS OFINSTRUMENTS CAST REMOVAL AC POWERED
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   APPLIER, CERCLAGE
Generic Device Name:   VARIOUS MODELS OF APPLIERS,CERCLAGE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS MODELS OF CUTTERS, WIRE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS MODELS OF BITS,DRILL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   STAPLE DRIVER
Generic Device Name:   VARIOUS MODELS OF STAPLE DRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS MODELS OF GAUGES, DEPTH
Proprietary Device Name:   MAULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.

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Last Modified: 29 April 2006
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