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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:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  UNIWORTH ENTERPRISES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  UNIWORTH ENTERPRISES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   PEARLITE ENTERPRISES
Registered Establishment Name:  PEARLITE ENTERPRISES.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   RESECTION CLAMP
Proprietary Device Name:   PROXIMAL TIBIAL RESECTION CLAMP
Registered Establishment Name:  SPECIALIZED ORTHOPAEDIC PRODUCTS LLC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   PROCYON SPINAL SYSTEM
Registered Establishment Name:  NAS MEDICAL TECHNOLOGIES, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   PORTABLE TRACTION DEVICE
Proprietary Device Name:   DISK-END
Registered Establishment Name:  HYUNDAI MEDICAL CO., LTD..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   RUCH CARPAL TUNNEL GLOVE
Proprietary Device Name:   RUCH CARPAL TUNNEL GLOVE
Registered Establishment Name:  PREEMINENT, LLC.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR CERVICAL PLATE
Proprietary Device Name:   INTUTIVE PLATE
Registered Establishment Name:  PRECISION SURGERY LTD..
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS MODELS OF SOCKET PUSHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   RONGEUR
Generic Device Name:   VARIOUS MODELS OF RONGEUR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS MODELS SURGICAL STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   TREPHINE
Generic Device Name:   VARIOUS MODELS OF TREPHINES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS MODELS OF WIRE TWISTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   WRENCH
Generic Device Name:   VARIOUS MODELS OF WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   SKID, BONE
Generic Device Name:   VARIOUS MODELS OF BONE SKIDS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS MODELS OF WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   VARIOUS MODELS OF PROSTHESIS DRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   VARIOUS MODELS OF NONPOWERED DYNAMOMETERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS MODELS EXTRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   FILE
Generic Device Name:   VARIOUS MODELS OF FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS MODELS OF GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   IMPACTOR
Generic Device Name:   VARIOUS MODELS OF IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   PROBE
Generic Device Name:   VARIUOS MODELS OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS MODELS ORTHOPEDIC KNIFE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   PROTRACTOR
Generic Device Name:   VARIOUS MODELS OF PROTRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   VARIOUS MODELS OF FEMORAL NECK PUNCH
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   APPLIER, CERCLAGE
Generic Device Name:   VARIOUS MODELS OF CERCLAGE APPLIERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   AWL
Generic Device Name:   VARIOUS MODELS OF AWLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS MODELS OF DRILL BRACES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   CALIPER
Generic Device Name:   VARIOUS MODELS OF CALIPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   VARIOUS MODELS OF GONIOMETERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  FALCON SURGICAL CO (PVT) LTD..
Classification:   GONIOMETER WITH ELECTRODES
Generic Device Name:   GONIOMETER W/ELECTRODES
Proprietary Device Name:   SONOSENS
Registered Establishment Name:  FRIENDLY SENSORS AG.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   SYNTHETIC, POROUS HYDROXYLAPATITE
Proprietary Device Name:   APAPORE BONE GRAFT SUBSTITUTE
Registered Establishment Name:  APATECH LTD..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  SATIN SKY ENTERPRISES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  SATIN SKY ENTERPRISES.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  SATIN SKY ENTERPRISES.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER
Registered Establishment Name:  SATIN SKY ENTERPRISES.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS BONE FASTENERS
Proprietary Device Name:   REPREVE SCREW SUPPLEMENT SYSTEM
Registered Establishment Name:  SIMPLICITY ORTHOPEDIC SOLUTIONS, LLC.
Classification:   APPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT
Generic Device Name:   FRACTURE FIXATION PLATING SYSTEM FOR FRACTURE FIXATION OF THE END OF LONG BONES
Proprietary Device Name:   VOLAR RADIUS PLATE WITH ANGULAR STABILITY
Registered Establishment Name:  I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH.

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Last Modified: 29 April 2006
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