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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:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDERS, ORTHOPEDICS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MOUNT BLONCK TRADING.
Classification:   PROBE
Generic Device Name:   VARIOUS KINDS OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MOUNT BLONCK TRADING.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  DERRON SURGICAL INSTRUMENTS, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  A & E INTERNATIONAL CO..
Classification:   ARTHROSCOPE
Generic Device Name:   ORTHOPEDICS
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  CORTEK ENDOSCOPY, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF OTHROPEDIC COMPONENTS
Proprietary Device Name:   ORTHOPEDIC COMPONENTS
Registered Establishment Name:  PERFORMANCE MACHINE TECHNOLOGIES.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   BACK STRECHER AND MASSAGER
Proprietary Device Name:   BACK STRECHER AND MASSAGER
Registered Establishment Name:  IMMUNOMED, LLC..
Classification:   COUNTERSINK
Generic Device Name:   VARIOUS
Proprietary Device Name:   MODULES SUPREMES
Registered Establishment Name:  USINAGE BOIS-FRANCS, INC..
Classification:   REAMER
Generic Device Name:   VARIOUS TYPES OF REAMER ATTACHMENTS FOR SURGICAL USE
Proprietary Device Name:   MICROPLANE SURGICAL PRODUCTS-REAMER, VARIOUS
Registered Establishment Name:  GRACE MANUFACTURING, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  GOGI ENT..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   LEADER BROTHERS PVT LTD.
Registered Establishment Name:  LEADER BROTHERS PVT LTD.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   LEADER BROTHERS PVT LTD.
Registered Establishment Name:  LEADER BROTHERS PVT LTD.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   LEADER BROTHERS PVT LTD.
Registered Establishment Name:  SUFAL INDUSTRIES (PVT) LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   LEADER BROTHERS PVT LTD.
Registered Establishment Name:  SUFAL INDUSTRIES (PVT) LTD..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONIOMETER, NONPOWERED
Proprietary Device Name:   GONIOMETER, NONPOWERED
Registered Establishment Name:  PLASTICARDS, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  EURO-MEDICAL GMBH.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONIOMETER, NONPOWERED
Proprietary Device Name:   GONIOMETER, NONPOWERED
Registered Establishment Name:  CREATIVE PROMOTIONAL PRODUCTS.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   BACK TRACTION UNIT
Proprietary Device Name:   BACKTRACTION.COM UNIT
Registered Establishment Name:  BACK TRAC.COM, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   COLLAGRAFT BONE SUBSTITUTE
Proprietary Device Name:   COLLAGRAFT STRIP BONE GRAFT MATRIX
Registered Establishment Name:  NEUCOLL, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN, S'ARL.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   VARIOUS COMPONENTS FOR SPINAL FIXATION
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN, S'ARL.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN, S'ARL.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   STERNAL KNIFE
Proprietary Device Name:   LEBSCHE STERNAL KNIFE
Registered Establishment Name:  CODMAN, S'ARL.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS SCISSORS FOR ORTHOPEDIC USE
Proprietary Device Name:   NONE
Registered Establishment Name:  CODMAN, S'ARL.
Classification:   BIT, DRILL
Generic Device Name:   DRILL BITS
Proprietary Device Name:   ACP DRILL ASSEMBLY
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   IMPACTOR
Generic Device Name:   IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   TAP, BONE
Generic Device Name:   BONE TAPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   WRENCH
Generic Device Name:   SURGICAL WRENCH & ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE TWISTING INSTRUMENT
Proprietary Device Name:   OCHSNER WIRE TWISTER
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   BENDER
Generic Device Name:   BENDING INSTRUMENT
Proprietary Device Name:   ACP CONTOUR BENDER
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   FIXATION ACCESSORY
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   CERCLAGE, FIXATION
Generic Device Name:   FIXATION CERCLAGE WIRE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   VARIOUS COMPONENTS FOR SPINAL FIXATION
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TEMPLATES FOR CLINICAL USE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CODMAN & SHURTLEFF, INC..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILL BITS
Proprietary Device Name:   BIT, DRILL (MULTIPLE BRANDS)
Registered Establishment Name:  ASANUS MEDIZINTECHNIK GMBH.

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Last Modified: 29 April 2006
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