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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:   CUTTER, WIRE
Generic Device Name:   VARIOUS MODELS OF WIRE CUTTERS, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  RUDOLF BUCK GMBH.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS MODELS OF BONE PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS MODELS OF SURGICAL SCRIPPERS, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   REAMER
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   FILE
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC SURGICAL FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC BURRS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC SURGICAL DRILLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS MODELS OF BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   APPLIER, CERCLAGE
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC PARHAM BAND,APPLIERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS MODELS OF BENDING OR CONTOURING INSTRUMENTS, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC SCREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS MODELS OF BONE NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.HANDTE MEDIZINTECHNIK GMBH & CO. KG.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  JOSEF HEISS GMBH.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS MODELS OF SURGICAL, ORTHOPEDIC STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   VARIOUS MODELS OF DYNAMOMETERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   FORK
Generic Device Name:   FORK
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   PLASTER CAST INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   COMPRESSION INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   CALIPER
Generic Device Name:   CALIPER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   WRENCH
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   PLATE, FIXATION, BONE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   COMPONENT, TRACTION, INVASIVE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KARL LEIBINGER GMBH U. CO. KG.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTING PLIERS
Proprietary Device Name:   WIRE CUTTING PLIERS
Registered Establishment Name:  ADOLF SCHWEICKHARDT GMBH & CO. KG.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLE HOLDERS FOR ORTHOPEDICAL USE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GUSTAV WECK.
Classification:   REAMER
Generic Device Name:   ZUELZER AWL USE
Proprietary Device Name:   ZMS TIBIAL AWL
Registered Establishment Name:  FRIEDRICH DANIELS GMBH.
Classification:   SKID, BONE
Generic Device Name:   SKID, BONE
Proprietary Device Name:   SKID, BONE
Registered Establishment Name:  FRIEDRICH DANIELS GMBH.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLE HOLDERS FOR ORTHOPEDICAL USE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FRIEDRICH DANIELS GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER, WIRE
Proprietary Device Name:   CUTTER, WIRE
Registered Establishment Name:  FRIEDRICH DANIELS GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   DISASSEMBLY INSTRUMENTS USE
Proprietary Device Name:   SCREW HOLDING FORCEPS
Registered Establishment Name:  FRIEDRICH DANIELS GMBH.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   BENDING IRON, COMP TECH
Proprietary Device Name:   BENDING IRON, COMP TECH
Registered Establishment Name:  FRIEDRICH DANIELS GMBH.
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   VARIOUS TYPES OF PUNCHES
Proprietary Device Name:   OFFSET PUNCH
Registered Establishment Name:  FRIEDRICH DANIELS GMBH.
Classification:   RONGEUR
Generic Device Name:   FORCEPS RONGEURE
Proprietary Device Name:   KERRISON, STILLE GRIENWALD LISTON, PITUITARY
Registered Establishment Name:  FRIEDRICH DANIELS GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GEOMED MEDIZIN-TECHNIK GMBH & CO..

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Last Modified: 29 April 2006
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