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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:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WITTE GMBH CHIRURGISCHE INSTRUMENTE.
Classification:   RONGEUR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MAX HAUSER SUDDEUTSCHE CHIRURGIE MECHANIK GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   BRACE, DRILL
Proprietary Device Name:   BRACE, DRILL
Registered Establishment Name:  GEORG LEIBINGER MEDIZINTECHNISCHER APPARATEBAU.
Classification:   GUIDE, DRILL, LIGAMENT
Generic Device Name:   GUIDE, DRILL, LIGAMENT
Proprietary Device Name:   GUIDE, DRILL, LIGAMENT
Registered Establishment Name:  GEORG LEIBINGER MEDIZINTECHNISCHER APPARATEBAU.
Classification:   BIT, DRILL
Generic Device Name:   BIT, DRILL
Proprietary Device Name:   BIT, DRILL
Registered Establishment Name:  GEORG LEIBINGER MEDIZINTECHNISCHER APPARATEBAU.
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   WRENCH
Registered Establishment Name:  GEORG LEIBINGER MEDIZINTECHNISCHER APPARATEBAU.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   SCREWDRIVER
Registered Establishment Name:  GEORG LEIBINGER MEDIZINTECHNISCHER APPARATEBAU.
Classification:   BIT, DRILL
Generic Device Name:   DRILL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MAHE-BARTHELMES MEDIZINTECHNIK GMBH.
Classification:   TAP, BONE
Generic Device Name:   TAP
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MAHE-BARTHELMES MEDIZINTECHNIK GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES OF TWISTER, WIRE, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HALL & SCHEIER.
Classification:   CALIPER
Generic Device Name:   VARIOUS TYPES OF CALIPER, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HALL & SCHEIER.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL KLAPPENECKER.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  USTOMED INSTRUMENTE ULRICH STORZ GMBH & CO. KG.
Classification:   FILE
Generic Device Name:   VARIOUS MODELS OF SURGICAL ORTHOPEDIC FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  USTOMED INSTRUMENTE ULRICH STORZ GMBH & CO. KG.
Classification:   RONGEUR
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  USTOMED INSTRUMENTE ULRICH STORZ GMBH & CO. KG.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  USTOMED INSTRUMENTE ULRICH STORZ GMBH & CO. KG.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC SCREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  USTOMED INSTRUMENTE ULRICH STORZ GMBH & CO. KG.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF STEEL BURRS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GEBR. BRASSELER GMBH & CO. KG.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL (MULTIPLE BRANDS)
Registered Establishment Name:  BACHER RALPH MEDIZINTECHNIK GMBH.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   ACCESSORIES, TRACTION
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  TREU-INSTRUMENTE GMBH.
Classification:   BIT, DRILL
Generic Device Name:   DRILL SURGICAL ORTHOPEDIC
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  TREU-INSTRUMENTE GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TREU-INSTRUMENTE GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   ORTHOPEDIC SCISSORS
Proprietary Device Name:   ORTHOPEDIC SCISSORS
Registered Establishment Name:  TREU-INSTRUMENTE GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER, WIRE
Proprietary Device Name:   CUTTER, WIRE
Registered Establishment Name:  TREU-INSTRUMENTE GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ANTON HIPP GMBH.
Classification:   ARTHROSCOPE
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH.
Classification:   BIT, DRILL
Generic Device Name:   KIRSHNER WIRE DRILL
Proprietary Device Name:   KIRSHNER WIRE DRILL
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   CRIMPER, PIN
Generic Device Name:   VARIOUS ORTHOPEDIC PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   TAMP
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   AWL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   TEMPLATE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   KIRSCHNER WIRES, STEINMANN PINS, BONNELL PINS, CERCLAGE WIRES
Proprietary Device Name:   BONE WIRES
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   KIRSCHNER WIRES, STEINMANN PINS, BONNELL PINS, CERCLAGE WIRES
Proprietary Device Name:   BONE WIRES
Registered Establishment Name:  STORK INSTRUMENTE GMBH.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   VARIOUS MODELS GRIP STRENGTH DYNAMOMETERS
Proprietary Device Name:   VARIOUS MODELS GRIP STRENGTH DYNAMOMETERS
Registered Establishment Name:  MILTEX GMBH.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS ORTHOPEDIC BURS
Proprietary Device Name:   VARIOUS MODELS ORTHOPEDIC BURS
Registered Establishment Name:  MILTEX GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS MODELS ORTHOPEDIC RONGEURS
Proprietary Device Name:   VARIOUS MODELS ORTHOPEDIC RONGEURS
Registered Establishment Name:  MILTEX GMBH.

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Last Modified: 29 April 2006
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