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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:   GONIOMETER, NONPOWERED
Generic Device Name:   JOINT ARTHROMETER
Proprietary Device Name:   JOINT ARTHROMETER
Registered Establishment Name:  DELFI MEDICAL INNOVATIONS, INC..
Classification:   SET, HOLLOW MILL
Generic Device Name:   SET, HOLLOW MILL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS MODELS OF DRIL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS MODELS OF SWREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   TAP, BONE
Generic Device Name:   VARIOUS MODELS OF BONE TAPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   PROSTHESIS, WRIST, HEMI-, ULNAR
Generic Device Name:   VARIOUS MODELS OF ULNAR HEAD PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   REAMER
Generic Device Name:   VARIOUS MODELS OF SURGICAL AND ORTHOPEDIC REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS MODELS OF BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS MODELS OF IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS MODELS OF EXTRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS MODELS OF DRILL BRACES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STUCKENBROCK MEDIZINTECHNIK GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  TINOPAL SURGICAL CORP. (PVT), LTD..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  TINOPAL SURGICAL CORP. (PVT), LTD..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Proprietary Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Registered Establishment Name:  TINOPAL SURGICAL CORP. (PVT), LTD..
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER, WIRE
Proprietary Device Name:   CUTTER, WIRE
Registered Establishment Name:  TINOPAL SURGICAL CORP. (PVT), LTD..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   ABSORBABLE FIXATION ROD
Proprietary Device Name:   BIOFIX BIODEGRADABLE FIXATION ROD
Registered Establishment Name:  BIOSCIENCE, LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   ISMAIL JEE
Registered Establishment Name:  ISMAIL JEE.
Classification:   ARTHROSCOPE
Generic Device Name:   FLEXIBLE ARTHROSCOPE AND ACCESSORIES
Proprietary Device Name:   MYELOTEC FLEXIBLE FIBEROPTIC ENDOSCOPE
Registered Establishment Name:  MYELOTEC, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS, BANDAGE, LISTER
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  GUANGDONG MEDICINES & HEALTH PRODUCTS CORP..
Classification:   INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT
Generic Device Name:   ULTRASONIC INSTRUMENT FOR BONE CEMENT REMOVAL
Proprietary Device Name:   OSCAR
Registered Establishment Name:  SRA DEVELOPMENTS, LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  VON ZABERN SURGICAL.
Classification:   EVACUATOR, VAPOR, CEMENT MONOMER
Generic Device Name:   EVACUATION & CONTAINMENT SYSTEM
Proprietary Device Name:   EVACUATION & CONTAINMENT SYSTEM
Registered Establishment Name:  NICHE MEDICAL, INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDER MULTIPLE
Proprietary Device Name:   NEEDLE HOLDER MULTIPLE
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   KNIFE ORTHOPEDIC MULTIPLE
Proprietary Device Name:   KNIFE ORTHOPEDIC MULTIPLE
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC INSTRUMENTS MULTIPLE
Proprietary Device Name:   ORTHOPEDIC INSTRUMENTS MULTIPLE
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   MEDICUT SHEARS, VARIOUS TYPES OF SHEARS
Proprietary Device Name:   MEDICUT SHEARS, VARIOUS TYPES OF SHEARS
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   WASHER, BOLT NUT
Generic Device Name:   WASHERS, NUT BOLT WASHERS, NUT BOLT
Proprietary Device Name:   WASHERS, NUT BOLT WASHERS, NUT BOLT
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   WIRE, SURGICAL
Generic Device Name:   TWISTED WIRE, ORTHOPEDIC WIRE, BONE WIRE, BONE HOLDING WIRE
Proprietary Device Name:   TWISTED WIRE, ORTHOPEDIC WIRE, BONE WIRE, BONE HOLDING WIRE
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SURGICAL STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   BIT, DRILL
Generic Device Name:   FINGER NAIL DRILL
Proprietary Device Name:   FINGER NAIL DRILL
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE HOLDING CLAMP
Proprietary Device Name:   WIRE HOLDING CLAMP
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   NAIL TRIMMER, NAIL DRILL
Proprietary Device Name:   NAIL TRIMMER, NAIL DRILL
Registered Establishment Name:  THE MUGHAL SURGICAL (PVT)LTD.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   WRIST TRACTION DEVICE
Proprietary Device Name:   CTR-2000
Registered Establishment Name:  JAZMON TECHNOLOGIES, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SAME
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CLIFF TRADING CO. (PVT) LTD..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATES
Proprietary Device Name:   BONE PLATES
Registered Establishment Name:  MCGRATH ORTHOPAEDICS LTD..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   STEINMANN PINS
Proprietary Device Name:   STEINMANN PINS
Registered Establishment Name:  MCGRATH ORTHOPAEDICS LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  MCGRATH ORTHOPAEDICS LTD..

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Last Modified: 29 April 2006
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