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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:   BRACE, DRILL
Generic Device Name:   VARIOUS DRILL BRACES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KMEDIC, TELEFLEX MEDICAL.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS TYPES OF CAST REMOVAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KMEDIC, TELEFLEX MEDICAL.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH PINS
Proprietary Device Name:   PIN, FIXATION, SMOOTH
Registered Establishment Name:  KMEDIC, TELEFLEX MEDICAL.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES OF THREADED PINS
Proprietary Device Name:   PIN, FIXATION, THREADED
Registered Establishment Name:  KMEDIC, TELEFLEX MEDICAL.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   STRIPPER, SURGICAL
Proprietary Device Name:   STRIPPER, SURGICAL
Registered Establishment Name:  KMEDIC, TELEFLEX MEDICAL.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   HOLDER, NEEDLE, ORTHOPEDIC
Registered Establishment Name:  ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP..
Classification:   EXTRACTOR
Generic Device Name:   IMPLANT REMOVER
Proprietary Device Name:   TITANIUM-TIPPED REVERSE MALLET IMPLANT REMOVER
Registered Establishment Name:  ORATRONICS, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE FIXATION DEVICES AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY CMW.
Classification:   BONE CEMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY CMW.
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   VARIOUS TYPES OF CEMENT MIXERS FOR CLINICAL USE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY CMW.
Classification:   EVACUATOR, VAPOR, CEMENT MONOMER
Generic Device Name:   VARIOUS TYPES OF CEMENT MONOMER VAPOR EVACUATORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY CMW.
Classification:   CEMENT OBTURATOR
Generic Device Name:   VARIOUS TYPES OF CEMENT OBTURATORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY CMW.
Classification:   BONE CEMENT, ANTIBIOTIC
Generic Device Name:   VARIOUS TYPES OF ANTIBIOTIC BONE CEMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY CMW.
Classification:   DISPENSER, CEMENT
Generic Device Name:   VARIOUS TYPES OF CEMENT DISPENSERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY CMW.
Classification:   CUTTER, WIRE
Registered Establishment Name:  LESAM, INC..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS SIZES AND TYPES OF BOLTS, NUTS, WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PILLING SURGICAL, TELEFLEX MEDICAL.
Classification:   BIT, DRILL
Generic Device Name:   DRILL BITS/BURRS
Proprietary Device Name:   HUDSON BURR BITS
Registered Establishment Name:  PILLING SURGICAL, TELEFLEX MEDICAL.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   LEBSCHE BLADE
Proprietary Device Name:   LEBSCHE STERNUM KNIFE
Registered Establishment Name:  PILLING SURGICAL, TELEFLEX MEDICAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR (VARIOUS TYPES)
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  PILLING SURGICAL, TELEFLEX MEDICAL.
Classification:   AWL
Generic Device Name:   AWL KIRKLAND STERNAL
Proprietary Device Name:   AWL ORTHOPEDIC
Registered Establishment Name:  PILLING SURGICAL, TELEFLEX MEDICAL.
Classification:   TREPHINE
Generic Device Name:   ORTHOPEDIC TREPHINE
Proprietary Device Name:   KEYES CUTANEOUS TREPHINE
Registered Establishment Name:  PILLING SURGICAL, TELEFLEX MEDICAL.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   INSTRUMENT, BENDING OR CONTOURING (VARIOUS TYPES)
Proprietary Device Name:   INSTRUMENT, BENDING OR CONTOURING
Registered Establishment Name:  PILLING SURGICAL, TELEFLEX MEDICAL.
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE TWISTING FORCEPS
Proprietary Device Name:   TWISTER, WIRE, ORTHOPEDIC
Registered Establishment Name:  PILLING SURGICAL, TELEFLEX MEDICAL.
Classification:   PROSTHESIS, TENDON, PASSIVE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  VYGON NEURO.
Classification:   INSTRUMENT, COMPRESSION
Registered Establishment Name:  CIRCULATOR BOOT CORP..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS TYPES AND SIZES OF PNEUMATIC ACCESSORIES AND ATTACHMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS TYPES AND SIZES OF NON-POWERED,APPARATUS,TRACTIONS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE FIXATION PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES SIZES OF DRILL BITS AND VARIOUS DRILLS AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES AND SIZES OF ROGEURS
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  SYNTHES (USA).
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES AND SIZES OF MEASURING DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE WASHERS,NUTS AND BOLTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   TAP, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE TAPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TYPES AND SIZES OF POSITIONING PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE FIXATION SCREWS
Proprietary Device Name:   SCREW
Registered Establishment Name:  SYNTHES (USA).
Classification:   IMPACTOR
Generic Device Name:   VARIOUS AND SIZES OF IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS TYPES AND SIZES OF BENDING AND CONTOURING INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   TAMP
Generic Device Name:   VARIOUS TYPES AND SIZES OF WIRE TIGHTNERS/TAMPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES AND SIZES OF WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).
Classification:   WIRE, SURGICAL
Generic Device Name:   VARIOUS TYPES AND SIZES OF SURGICAL WIRE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES (USA).

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Last Modified: 29 April 2006
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