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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:   FILE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC SURGICAL FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLGAIER INSTRUMENTE GMBH.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC SURGICAL DRILLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLGAIER INSTRUMENTE GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLGAIER INSTRUMENTE GMBH.
Classification:   AWL
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC AWLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLGAIER INSTRUMENTE GMBH.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS TYPES OF BENDING OF CONTOURING ORTHOPEDIC INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLGAIER INSTRUMENTE GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES OF SCREW DRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLGAIER INSTRUMENTE GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLGAIER INSTRUMENTE GMBH.
Classification:   CALIPER
Generic Device Name:   VARIOUS TYPES OF CALIPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLGAIER INSTRUMENTE GMBH.
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   AWL
Registered Establishment Name:  HELMUT ZEPF MEDIZINTECHNIK GMBH.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HELMUT ZEPF MEDIZINTECHNIK GMBH.
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  HELMUT ZEPF MEDIZINTECHNIK GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS, ORTHOPEDIC
Proprietary Device Name:   RONGEURS
Registered Establishment Name:  WEBA MEDIZINTECHNIK GMBH & CO..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF SURGICAL NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE PRIVAT LABEL
Registered Establishment Name:  E.G. VORLING KG.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   CAST SPREADER
Proprietary Device Name:   MULTIPLE PRIVAT LABEL
Registered Establishment Name:  E.G. VORLING KG.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTER
Proprietary Device Name:   MULTIPLE PRIVAT LABEL
Registered Establishment Name:  E.G. VORLING KG.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SURGICAL SCISSORS
Proprietary Device Name:   MULTIPLE PRIVAT LABEL
Registered Establishment Name:  E.G. VORLING KG.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  E.G. VORLING KG.
Classification:   GUIDE, DRILL, LIGAMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  E.G. VORLING KG.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF KNIFE ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF STORZ GMBH.
Classification:   SKID, BONE
Generic Device Name:   VARIOUS TYPES OF SKID, BONE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF STORZ GMBH.
Classification:   TREPHINE
Generic Device Name:   TREPHINE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF STORZ GMBH.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   NONPOWERED GONIOMETER/ORTHOPEDIC GONIOMETER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF STORZ GMBH.
Classification:   CALIPER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF STORZ GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF STORZ GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF MANUAL SURGICAL INSTUMENTS
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (MULTIPLE BRANDS)
Registered Establishment Name:  RUDOLF STORZ GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS OPTHALMIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCHULTZ INSTRUMENTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  RUDOLF MEDICAL GMBH + CO. KG.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   KNIFE, ORTHOPEDIC
Proprietary Device Name:   KNIFE, ORTHOPEDIC
Registered Establishment Name:  RUDOLF MEDICAL GMBH + CO. KG.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  RUDOLF MEDICAL GMBH + CO. KG.
Classification:   APPLIER, CERCLAGE
Generic Device Name:   APPLIER, CERCLAGE
Proprietary Device Name:   APPLIER, CERCLAGE
Registered Establishment Name:  RUDOLF MEDICAL GMBH + CO. KG.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Proprietary Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Registered Establishment Name:  RUDOLF MEDICAL GMBH + CO. KG.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF MEDICAL GMBH + CO. KG.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF MEDICAL GMBH + CO. KG.
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS TYPES OF ARTHROSCOPES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF MEDICAL GMBH + CO. KG.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS TYPES OF STRIPPERS SURGICAL ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDISCHHAUSER GMBH.
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WRENCHS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC CLAMPS
Proprietary Device Name:   NOT STATED
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   VARIUS TYPES OF IMPLANTS
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AUGUST REUCHLEN GMBH.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF PLATE, BONE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AUGUST REUCHLEN GMBH.

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Last Modified: 29 April 2006
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