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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:   HALTER, HEAD, TRACTION
Generic Device Name:   VARIOUS MODELS OF HALTERS,HEAD,TRACTION
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS MODELS OF INSTRUMENTS,SURGICAL,ORTHOPEDIC,DCPOWERDM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   APPLIANCE, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Generic Device Name:   VARIOUS MODELS OF APPLIANCES,NAIL/BLADE/PLATE COMB.SING.COPONENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS MODELS OF NAILS,FIXATION,BONE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS OF PASSERS, WIRE, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   PROBE
Generic Device Name:   VARIOUS MODELS OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   REAMER
Generic Device Name:   VARIOUS MODELS OF REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS MODELS OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS MODELS OF SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS MODELS OF SCREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS MODELS OF TWISTERS, WIRE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   WIRE, SURGICAL
Generic Device Name:   VARIOUS MODELS OF WIRES, SURGICAL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   WRENCH
Generic Device Name:   VARIOUS MODELS OF WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   POSITIONER, SOCKET
Generic Device Name:   VAUIOUS TYPES OF SOCKET POSITIONER
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC NEEDLE HOLDER
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SURGICAL STRIPPERS
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC KNIFE
Proprietary Device Name:   MULTIPLE PRIVATE LABEL
Registered Establishment Name:  DIMEDA INSTRUMENTE GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   BRACE, ORTHOPEDIC
Proprietary Device Name:   EPICONDYLITIS-CLASP
Registered Establishment Name:  THAEMERT ORTHOPAEDISCHE HILFSMITTEL GMBH & CO..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TIM TUTTINGER INSTRUMENTEN MANUFAKTUR.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MICHELE CANNOVA CHIRURGISCHE INSTRUMENTE.
Classification:   BIT, DRILL
Generic Device Name:   ORTHOPEDIC DRILL BIT
Proprietary Device Name:   DRILL BIT
Registered Establishment Name:  MICHELE CANNOVA CHIRURGISCHE INSTRUMENTE.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   SURGICAL INSTRUMENT, ORTHOPEDIC AC-POWERED MOTOR
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  GEISTER MEDIZINTECHNIK GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GEISTER MEDIZINTECHNIK GMBH.
Classification:   PROBE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GEISTER MEDIZINTECHNIK GMBH.
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GEISTER MEDIZINTECHNIK GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   TWISTER, WIRE (VARIOUS TYPES)
Proprietary Device Name:   TWISTER, WIRE (MULTIPLE BRANDS)
Registered Establishment Name:  GEISTER MEDIZINTECHNIK 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:  GEISTER MEDIZINTECHNIK GMBH.
Classification:   RONGEUR
Generic Device Name:   RONGEUR (VARIOUS TYPES)
Proprietary Device Name:   RONGEUR (MULTIPLE BRANDS)
Registered Establishment Name:  GEISTER MEDIZINTECHNIK GMBH.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   TWISTER, WIRE
Proprietary Device Name:   TWISTER, WIRE (MULTIPLE BRANDS)
Registered Establishment Name:  NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDER
Proprietary Device Name:   NEEDLE HOLDER
Registered Establishment Name:  KOHLER MEDIZINTECHNIK GMBH & CO. KG.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTERS
Proprietary Device Name:   WIRE CUTTING PLIERS, END NIPPERS
Registered Establishment Name:  KOHLER MEDIZINTECHNIK GMBH & CO. KG.
Classification:   BONE MILL
Generic Device Name:   DENTAL BONE CRUSHER
Proprietary Device Name:   BONE MILL-BONE CRUSHER, FOR DENTAL USE
Registered Establishment Name:  KOHLER MEDIZINTECHNIK GMBH & CO. KG.
Classification:   BENDER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PRO-MED INSTRUMENTE GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PRO-MED INSTRUMENTE GMBH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PRO-MED INSTRUMENTE GMBH.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PRO-MED INSTRUMENTE GMBH.

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Last Modified: 29 April 2006
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