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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:   SKID, BONE
Generic Device Name:   VARIOUS MODELS BONE SKIDS
Proprietary Device Name:   VARIOUS MODELS BONE SKIDS
Registered Establishment Name:  MILTEX GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS MODELS ORTHOPEDIC WIRE TWISTERS
Proprietary Device Name:   VARIOUS MODELS ORTHOPEDIC WIRE TWISTERS
Registered Establishment Name:  MILTEX GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS MODELS ORTHOPEDIC BRACE DRILLS
Proprietary Device Name:   VARIOUS MODELS ORTHOPEDIC BRACE DRILLS
Registered Establishment Name:  MILTEX GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS MODELS ORTHOPEDIC WIRE CUTTERS
Proprietary Device Name:   VARIOUS MODELS ORTHOPEDIC WIRE CUTTERS
Registered Establishment Name:  MILTEX GMBH.
Classification:   CALIPER
Generic Device Name:   STRUT CALIPER
Proprietary Device Name:   MILTEX STRUT CALIPER
Registered Establishment Name:  MILTEX GMBH.
Classification:   FILE
Generic Device Name:   ORTHOPEDIC BONE FILE
Proprietary Device Name:   MILTEX
Registered Establishment Name:  MILTEX GMBH.
Classification:   PROBE
Generic Device Name:   ORTHOPEDIC PROBE
Proprietary Device Name:   MILTEX
Registered Establishment Name:  MILTEX GMBH.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   CAST REMOVAL SPREADERS AND KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MILTEX GMBH.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   BUNNEL TENDON STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MILTEX GMBH.
Classification:   AWL
Generic Device Name:   ORTHOPEDIC AWL, VARIOUS MODELS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MILTEX GMBH.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   POLK FINGER GONIOMETERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MILTEX GMBH.
Classification:   WIRE, SURGICAL
Generic Device Name:   SURGICAL WIRE, VARIOUS MODELS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MILTEX GMBH.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS ORTHOPEDIC KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MILTEX GMBH.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  GIMMI GMBH.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   SAW
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   KNIFE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   BIT, DRILL
Generic Device Name:   DRILL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   AWL
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  GIMMI GMBH.
Classification:   TREPHINE
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  GIMMI GMBH.
Classification:   PROBE
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  GIMMI GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  GIMMI GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   BRACE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER WIRE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   NAIL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONIOMETER
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  GIMMI GMBH.
Classification:   TAMP
Generic Device Name:   WIRE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS,ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   BENDER
Generic Device Name:   BENDER,ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GIMMI GMBH.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPES
Proprietary Device Name:   ARTHROSCOPES
Registered Establishment Name:  GIMMI GMBH.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   MANUAL CAST APPLICATION AND REMOVAL INSTRUMENT
Proprietary Device Name:   MATTES MANUAL CAST APPLICATION AND REMOVAL INSTRUMENT
Registered Establishment Name:  MATTES-INSTRUMENTE.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTER
Proprietary Device Name:   MATTES WIRE CUTTER
Registered Establishment Name:  MATTES-INSTRUMENTE.
Classification:   TAP, BONE
Generic Device Name:   BONE TAP
Proprietary Device Name:   MATTES BONE TAP
Registered Establishment Name:  MATTES-INSTRUMENTE.
Classification:   RONGEUR
Generic Device Name:   BOYNTON RONGEUR
Proprietary Device Name:   BOYNTON RONGEUR
Registered Establishment Name:  BISELLI INSTRUMENTS GMBH & CO. KG.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLEHOLDER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BISELLI INSTRUMENTS GMBH & CO. KG.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BISELLI INSTRUMENTS GMBH & CO. KG.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  LAWTON GMBH & CO. KG.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS TYPES OF INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  MEDI PLUS INSTRUMENTE GMBH & CO. KG.

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Last Modified: 29 April 2006
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