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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:  HERMANN MUELLER INH. GEBHARD MUELLER.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   STRIPPER, SURGICAL
Proprietary Device Name:   STRIPPER, SURGICAL
Registered Establishment Name:  HERMANN MUELLER INH. GEBHARD MUELLER.
Classification:   TAMP
Generic Device Name:   TAMP
Proprietary Device Name:   TAMP
Registered Establishment Name:  HERMANN MUELLER INH. GEBHARD MUELLER.
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   BONE CEMENT MIXER AND DISPENSER
Proprietary Device Name:   UNITARY BONE CEMENT MIXER/DISPENSER
Registered Establishment Name:  ADVANCED BIOMATERIAL SYSTEMS, INC..
Classification:   DISPENSER, CEMENT
Generic Device Name:   BONE CEMENT MIXER AND DISPENSER
Proprietary Device Name:   UNITARY BONE CEMENT MIXER/DISPENSER
Registered Establishment Name:  ADVANCED BIOMATERIAL SYSTEMS, INC..
Classification:   BONE CEMENT
Generic Device Name:   POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
Proprietary Device Name:   CONCERT RADIOPAQUE BONE CEMENT
Registered Establishment Name:  ADVANCED BIOMATERIAL SYSTEMS, INC..
Classification:   CEMENT, BONE, VERTEBROPLASTY
Generic Device Name:   PMMA
Proprietary Device Name:   SYMPHONY VR
Registered Establishment Name:  ADVANCED BIOMATERIAL SYSTEMS, INC..
Classification:   COMPONENT, CAST
Generic Device Name:   CAST BANDAGE
Proprietary Device Name:   3B, DUROLITE, CBXXX
Registered Establishment Name:  AMERICAN WEST TRADING CO..
Classification:   RONGEUR
Generic Device Name:   VARIOUS STYLES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  POST SURGICAL MFG., 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:   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.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS STYLES OF IMPACTORS
Proprietary Device Name:   ORTHOPEDIC IMPACTOR
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   PROBE
Generic Device Name:   VARIOUS STYLES OF ORTHOPEDIC) PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   CEMENT, BONE, VERTEBROPLASTY
Generic Device Name:   RADIOPAQUE BONE CEMENT
Proprietary Device Name:   AVA-TEX
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   TAMP
Generic Device Name:   VARIOUS TYPES AND SIZES OF TAMPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES AND SIZES OF SCREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   CALIPER
Generic Device Name:   VARIOUS TYPES AND SIZES OF CALIPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES AND SIZES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARDINAL HEALTH.
Classification:   ARTHROSCOPE
Generic Device Name:   RIGID ENDOSCOPE
Proprietary Device Name:   SIGHT-PLUS ARTHROSCOPE
Registered Establishment Name:  BLAZEJEWSKI MEDI-TECH.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONOMETER
Proprietary Device Name:   PLURIMETER
Registered Establishment Name:  PLURIMETER GONIO SYSTEM.
Classification:   ARTHROSCOPE
Generic Device Name:   ENDOSCOPE AND ACCESSORIES
Proprietary Device Name:   ARTHROSCOPE AND ACCESSORIES
Registered Establishment Name:  ENDO IMAGE CORP..
Classification:   PROSTHESIS, TOE, HEMI-, PHALANGEAL
Generic Device Name:   TOE RING
Proprietary Device Name:   TOE RING
Registered Establishment Name:  HUNTEX CORPORATION.
Classification:   PROSTHESIS, KNEE, HINGED (METAL-METAL)
Generic Device Name:   VARIOUS TYPES OF EXTERNAL LIMB PROSTHETICS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PABISCH S.P.A..
Classification:   DISPENSER, CEMENT
Generic Device Name:   BONE CEMENT DELIVERY SYSTEM
Proprietary Device Name:   OSTEOJECT BONE CEMENT DELIVERY SYSTEM
Registered Establishment Name:  SPINAL SPECIALTIES, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  MOHSAN SURGICAL INDUSTRIES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PASSAU IMPEX.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   BROMED SURGICAL (PRIVATE) LIMITED
Registered Establishment Name:  BROMED SURGICAL (PVT) LTD..
Classification:   PROBE
Generic Device Name:   PROBES
Proprietary Device Name:   BROMED SURGICAL (PRIVATE) LIMITED
Registered Establishment Name:  BROMED SURGICAL (PVT) LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   BEERE PRECISION MEDICAL INSTRUMENTS INC
Registered Establishment Name:  BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF.

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Last Modified: 29 April 2006
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