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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 TYPES OF CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   SCREWDRIVER
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS TYPES OF STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   TAP, BONE
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   PROBE
Generic Device Name:   DESJARDINS PROBE
Proprietary Device Name:   DESJARDINS PROBE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   TAMP
Generic Device Name:   VARIOUS TYPES OF INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS TYPES OF INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   TREPHINE
Generic Device Name:   VARIOUS TYPES OF INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   BENDER
Generic Device Name:   VARIOUS TYPES OF INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   COUNTERSINK
Generic Device Name:   VARIOUS INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TYPES OF INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES OF INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   WIRE, SURGICAL
Generic Device Name:   SAME
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  KLS-MARTIN L.P..
Classification:   CALIPER
Generic Device Name:   BODY FAT CALIPER
Proprietary Device Name:   ACCU-MEASURE, EASY-MEASURE, ACCU-TRACK
Registered Establishment Name:  ACCU-MEASURE, LLC..
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   EXPANDABLE VERTEBRAL BODY REPLACEMENT PROSTHESIS, VARIOUS SIZES
Proprietary Device Name:   LEVANTE INTERVERTEBRAL PILLAR
Registered Establishment Name:  IONICS MEDICAL CORP..
Classification:   COMPONENT, CAST
Generic Device Name:   VARIOUS SIZES OF CASTING TAPES
Proprietary Device Name:   DUROLITE CASTING TAPE
Registered Establishment Name:  HUANG YAN MEDICAL SUPPLY FACTORY.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION SET
Proprietary Device Name:   TRACTION SET
Registered Establishment Name:  C-TRADER INDUSTRIAL, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS SIZES OF BONE FIXATION SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARNO FRITZ,CHIRURGISCHE INSTRUMENTE.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS STYLES & STYLES OF WIRE CUTTER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  M.F. ELAHI & CO. (EP) PVT. LTD..
Classification:   CALIPER
Generic Device Name:   CALIPERS
Proprietary Device Name:   55 CM BODY CALIPER
Registered Establishment Name:  MEDTEC.
Classification:   PROTRACTOR
Generic Device Name:   BREAST BRIDGE ANGULATION
Proprietary Device Name:   MT-BBO1 BREAST BRIDGE
Registered Establishment Name:  MEDTEC.
Classification:   RONGEUR
Generic Device Name:   DEVILBISS RONQEUR
Proprietary Device Name:   DEVILBISS RONQEUR
Registered Establishment Name:  TONTARRA MEDIZINTECHNIK GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TONTARRA 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:  TONTARRA MEDIZINTECHNIK GMBH.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONIOMETER, NONPOWERED (VARIOUS TYPES)
Proprietary Device Name:   GONIOMETER, NONPOWERED (MULTIPLE BRANDS)
Registered Establishment Name:  TONTARRA MEDIZINTECHNIK GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   BRACE, DRILL (VARIOUS TYPES)
Proprietary Device Name:   BRACE, DRILL (MULTIPLE BRANDS)
Registered Establishment Name:  TONTARRA MEDIZINTECHNIK GMBH.
Classification:   BIT, DRILL
Generic Device Name:   BIT, DRILL (VARIOUS TYPES)
Proprietary Device Name:   BIT, DRILL (MULTIPLE BRANDS)
Registered Establishment Name:  TONTARRA MEDIZINTECHNIK GMBH.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   DYNAMOMETER, NONPOWERED (VARIOUS TYPES)
Proprietary Device Name:   DYNAMOMETER, NONPOWERED (MULTIPLE BRANDS)
Registered Establishment Name:  TONTARRA MEDIZINTECHNIK GMBH.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   NON-POWERED DYNOMETER,NON-POWERED GONIOMETER
Proprietary Device Name:   INFOTRONIC DYNOMETER/GONIOMETER/ULTRAFLEX
Registered Establishment Name:  INFOTRONIC MEDICAL ENGINEERING.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  EXPLORENT GMBH.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF BURR
Proprietary Device Name:   BURR
Registered Establishment Name:  EXPLORENT GMBH.
Classification:   BENDER
Generic Device Name:   ROD BENDER
Proprietary Device Name:   BIOQUEST ROD BENDER
Registered Establishment Name:  BIOQUEST.
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   KNEE DRIVER
Proprietary Device Name:   BIOQUEST UNIVERSAL KNEE DRIVER
Registered Establishment Name:  BIOQUEST.
Classification:   TEMPLATE
Generic Device Name:   FMORAL NECK CUT GUIDE
Proprietary Device Name:   HEDLEY UNIVERSAL NECK CUT GUIDE
Registered Establishment Name:  BIOQUEST.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDER ,ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AURIGA INTL..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INTERPORE CROSS INTL..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INTERPORE CROSS INTL..

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Last Modified: 29 April 2006
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