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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:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF SCREW, BONE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   TAP, BONE
Generic Device Name:   VARIOUS TYPES OF TAP, BONE SCREW
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   TWISTER, WIRE
Proprietary Device Name:   TWISTER, WIRE
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   BRACE, DRILL
Proprietary Device Name:   BRACE, DRILL
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   GAUGE, DEPTH
Generic Device Name:   GAUGE, DEPTH
Proprietary Device Name:   GAUGE, DEPTH
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF OF WIRE CUTTERS
Proprietary Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS MODELS OF STEEL CUTTERS
Proprietary Device Name:   STEEL CUTTER
Registered Establishment Name:  KARL REICHLE & CO..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   AWL
Registered Establishment Name:  KARL REICHLE & CO..
Classification:   POSITIONER, SOCKET
Generic Device Name:   POSITIONER
Proprietary Device Name:   SURGYCAL PLATE POSITIONER
Registered Establishment Name:  H.S HOSPITAL SERVICE S.P.A..
Classification:   ARTHROSCOPE
Generic Device Name:   TELESCOPES,TROCARS,&ACCESSORIES
Proprietary Device Name:   ARTHROSCOPY
Registered Establishment Name:  OLYMPUS WINTER & IBE GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   CALIPER
Generic Device Name:   CLINICAL CALIPERS
Proprietary Device Name:   SLIDE CALIPERS OF STAINLESS STEEL & SYNTHETIC MATERIALS
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   TAP, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   PASSER
Generic Device Name:   VARIOUS
Proprietary Device Name:   TENDON PASSING INSTRUMENTS
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (VARIOUS TYPES)
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (MULTIPLE BRANDS)
Registered Establishment Name:  HEBUMEDICAL GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  OTTO RUTTGERS GMBH CO. KG.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  OTTO RUTTGERS GMBH CO. KG.
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS TYPES OF EXTRACTOR, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  OTTO RUTTGERS GMBH CO. KG.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GEBRUEDER ZEPF.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS TYPES OF CAST APPLICATION/REMOVAL INSTRUMENTS, MANUAL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GEBRUEDER ZEPF.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GEBRUEDER ZEPF.
Classification:   PROBE
Generic Device Name:   VARIOUS
Proprietary Device Name:   PROBE
Registered Establishment Name:  GEBRUEDER ZEPF.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF MANUAL ORTHOPEDIC SURGICAL INSTRUMENT AND HANDLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GEBRUEDER ZEPF.
Classification:   ARTHROSCOPE
Generic Device Name:   CANNULA & TROCARS FOR ARTHROSCOPIC PROCEDURES
Proprietary Device Name:   ARTHROSCOPIC CANNULA & TROCARS
Registered Establishment Name:  VOMED VOLZER MEDIZINTECHNIK GMBH & CO..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SAME
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  REMA MEDIZINTECHNIK GMBH..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  REMA MEDIZINTECHNIK GMBH..
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   SAME
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  REMA MEDIZINTECHNIK GMBH..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  RAIMUND WENZLER GMBH, INSTRUMENTEN-MANUFAKTUR.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   VARIOUS TYEPS OF COMPRESSION INSTRUMENTS
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  RAIMUND WENZLER GMBH, INSTRUMENTEN-MANUFAKTUR.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  RAIMUND WENZLER GMBH, INSTRUMENTEN-MANUFAKTUR.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPE OF SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  RAIMUND WENZLER GMBH, INSTRUMENTEN-MANUFAKTUR.

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Last Modified: 29 April 2006
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