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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:   TAP, BONE
Generic Device Name:   VARIOUS BONE TAPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   PROBE
Generic Device Name:   VARIOUS PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   CROSSPIN
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   WASHER, BOLT NUT
Generic Device Name:   WASHER,NUT,BOLT,ORTHOPAEDIC
Proprietary Device Name:   MULTIPLE WASHER,NUT,BOLT
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   FASTENER,FIXATION,BIODEGRADABLE SOFT TISSUE ANCHOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   PIN,FIXATION,SMOOTH
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   FASTENER,FIXATION,NON-BIODEGRADABLE,SOFT TISSUE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY MITEK, A JOHNSON & JOHNSON COMPANY.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREW ABD NUT
Registered Establishment Name:  UNITED PRECISION TECHNOLOGY.
Classification:   PUMP, VACUUM, ELECTRIC, SUCTION-TYPE ELECTRODE
Generic Device Name:   SUCTION PUMP
Proprietary Device Name:   MEDIVAC
Registered Establishment Name:  MEDISONIC U.S.A., INC..
Classification:   FILE
Generic Device Name:   FILE, SURGICAL ORTHOPEDIC
Registered Establishment Name:  ELMED, INC..
Classification:   TREPHINE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   TEMPLATE
Generic Device Name:   RUBBER DAM TEMPLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   WIRE, SURGICAL
Generic Device Name:   SURGICAL WIRE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS MODELS OF SURGICAL STRIPPERS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   NONPOWERED DYNAMOMETER
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   BIT, DRILL
Generic Device Name:   SURGICAL DRILL BIT, VARIOUS MODELS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   RONGEUR
Generic Device Name:   RONGEUR VARIOUS TYPES
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   AWL
Generic Device Name:   SURGICAL AWL, VARIOUS MODELS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   BRACE, DRILL
Generic Device Name:   MANUAL DRILL BRACE, SURGICAL, VARIOUS MODELS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   NON-POWERED GONIOMETER
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS TYPES OF MANUAL INSTRUMENTS FOR COAST APPLICATION.REMOVAL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HU-FRIEDY MFG. CO.,INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS SIZES OF STERLE CURETTES AND SCULPS KNIVES
Proprietary Device Name:   WHITNEY CURETTE AND WHITNEY SCULPS KNIFE
Registered Establishment Name:  WHITNEY PRODUCTS, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS TYPES OF SURGICAL MOTOR AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   CERCLAGE, FIXATION
Generic Device Name:   VARIOUS TYPES OF CERCLAGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS STYLES OF PNEUMATIC SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS STYLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS TYPES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION APPARATUS
Proprietary Device Name:   SHOULDER TRACTION KIT
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS STYLES OF SURGICAL STRIPPERS
Proprietary Device Name:   SURGICAL STRIPPERS
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   RONGEUR
Generic Device Name:   VARIOUS STYLES OF ORTHOPEDIC RANGEURS
Proprietary Device Name:   ORTHOPEDIC RONGEUR
Registered Establishment Name:  CARDINAL HEALTH.

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Last Modified: 29 April 2006
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