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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:   ARTHROSCOPE
Generic Device Name:   FLEXIBLE ARTHROSCOPE AND ACCESSORIES
Proprietary Device Name:   MYELOTEC FLEXIBLE FIBEROPTIC ENDOSCOPE
Registered Establishment Name:  SCIRON SOLUTIONS, LLC.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   KNIFE ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  M & M DENTAL CORP..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SCREW BONE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  M & M DENTAL CORP..
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  M & M DENTAL CORP..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  M & M DENTAL CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  M & M DENTAL CORP..
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TYPES AND SIZES OF BENDING PLATES
Proprietary Device Name:   MULTIPLE BENDING PLATES
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS TYPES OF CAST REMOVAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE, MANUAL CAST REMOVAL INSTRUMENTS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   AWL
Generic Device Name:   VARIOUS TYPES OF AWLS
Proprietary Device Name:   MULTIPLE AWLS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   BENDER
Generic Device Name:   VARIOUS TYPES OF ROD BENDERS
Proprietary Device Name:   MULTIPLE ROD BENDERS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   COUNTERSINK
Generic Device Name:   VARIOUS TYPES OF COUNTERSINKS
Proprietary Device Name:   MULTIPLE COUNTERSINKS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF CUTTERS
Proprietary Device Name:   MULTIPLE WIRE CUTTERS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE DEPTH GAUGES
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE NEEDLE HOLDERS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES
Proprietary Device Name:   MULTIPLE PROBES
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILL BRACES
Proprietary Device Name:   MULTIPLE DRILL BRACES
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE RONGEURS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES OF SCREWDRIVERS
Proprietary Device Name:   MULTIPLE SCREWDRIVERS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   MULTIPLE SCISSORS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES OF TWISTERS
Proprietary Device Name:   MULTIPLE TWISTERS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   WIRE, SURGICAL
Generic Device Name:   VARIOUS TYPES OF WIRES
Proprietary Device Name:   MULTIPLE SURGICAL WIRES
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   PASSER
Generic Device Name:   VARIOUS TYPES OF PASSERS
Proprietary Device Name:   MULTIPLE PASSERS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH PINS
Proprietary Device Name:   SMOOTH PINS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES OF THREADED PINS
Proprietary Device Name:   THREADED PINS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   SURGICAL STRIPPERS
Proprietary Device Name:   SURGICAL STRIPPERS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILL BITS
Proprietary Device Name:   DRILL BIT
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   TAMP
Generic Device Name:   VARIOUS TYPES OF TAMPS
Proprietary Device Name:   MULTIPLE TAMPS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   TREPHINE
Generic Device Name:   VARIOUS TYPES OF TREPHINES
Proprietary Device Name:   MULTIPLE TREPHINES
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   TAP, BONE
Generic Device Name:   VARIOUS TYPES OF TAPS
Proprietary Device Name:   MULTIPLE BONE TAPS
Registered Establishment Name:  KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   CHAUDHRY SURGICAL PRODUCTION SUPPLIES
Registered Establishment Name:  CHAUDHRY SURGICAL PRODUCTION SUPPLIES.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   SCALPEL
Proprietary Device Name:   BEST-TECH ANNULOTOMY KNIFE
Registered Establishment Name:  SPINUS, LLC.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  SAR-SONS SURGICAL.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  SAR-SONS SURGICAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  SAR-SONS SURGICAL.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  SAR-SONS SURGICAL.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL
Proprietary Device Name:   MULTIPLE NAMES
Registered Establishment Name:  GOLD TIER ENTERPRISES.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MICROSURGICAL INSTRUMENTS CLOSE JOINT STOCK CO..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   CERVICAL TRACTION
Proprietary Device Name:   PETTIBON CERVICAL REPETITIVE TRACTION
Registered Establishment Name:  THE PETTIBON SYSTEM.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   MICRO NEEDLE HOLDER
Proprietary Device Name:   MICRO NEEDLE HOLDER
Registered Establishment Name:  SOBYTEK INSTRUMENTS CO..
Classification:   CUTTER, WIRE
Generic Device Name:   ORTHOPEDIC WIRE CUTTER
Proprietary Device Name:   ORTHOPEDIC WIRE CUTTER
Registered Establishment Name:  SOBYTEK INSTRUMENTS CO..

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Last Modified: 29 April 2006
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