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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,STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDISISS.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS ORTHOPEDIC BURRS,STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDISISS.
Classification:   REAMER
Generic Device Name:   VARIOUS REAMERS,STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDISISS.
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS ARTHROSCOPE AND ACCESSORIES,STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDISISS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS ORTHOPEDIC SURGICAL SCISSORS,STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDISISS.
Classification:   STAPLE DRIVER
Generic Device Name:   VARIOUS STAPLE DRIVERS,STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDISISS.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS DRILL BITS,STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDISISS.
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   ORTHOPEDIC ARTHROSCOPIC ACCESSORIES, STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDISISS.
Classification:   COMPONENT, CAST
Generic Device Name:   COMPONENT, CAST (VARIOUS TYPES)
Proprietary Device Name:   COMPONENT, CAST (MULTIPLE BRANDS)
Registered Establishment Name:  BSN MEDICAL LTD.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPIC SHAVERS AND BURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   BURR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   TAP, BONE
Generic Device Name:   TAP
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   CARPAL TUNNEL BLADE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   GUIDE PIN, DISTRACTION PIN, STEINMAN PIN
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   TREPHINE
Generic Device Name:   TREPHINE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   COUNTERSINK
Generic Device Name:   COUNTERSINK
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   ORTHOPEDIC CANNULAS AND TROCARS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   EXTERNAL FIXATION DEVICE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Generic Device Name:   EXTERNAL FIXATION DEVICE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   EXTERNAL FIXATION DEVICE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   CARTILAGE KNIFE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   AUTO GRAFT & REPAIR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   CEMENT MIXER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALLIANCE MEDICAL CORP..
Classification:   COMPONENT, CAST
Generic Device Name:   VARIOUS TYPES OF ROCKER BOOTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MAQUILADORA DE COAHUILA, SOCIEDAD ANONIMA.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   12 SIZES OF BROACH
Proprietary Device Name:   MTO G2 12/14 BROACH
Registered Establishment Name:  E. REED & SONS LTD..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS SIZES OF BONE FIXATION APPLIANCE SYSTEMS AND ACCESSORIES
Proprietary Device Name:   MODUS MODULAR OSTEOSYNTHESIS SYSTEM
Registered Establishment Name:  MEDARTIS AG.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC SURGICAL INSTRUMENTS
Proprietary Device Name:   MODUS INSTRUMENTS
Registered Establishment Name:  MEDARTIS AG.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREW
Proprietary Device Name:   MODUS SELF-DRILLING SCREW
Registered Establishment Name:  MEDARTIS AG.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  EFINGER INSTRUMENTS.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS HAND HELD MANUAL INSTRUMENT
Proprietary Device Name:   BAILEY INSTRUMENTS
Registered Establishment Name:  BAILEY INSTRUMENTS LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   CEMENT PRESSURIZER
Proprietary Device Name:   CEMENT PRESSURIZER
Registered Establishment Name:  TECRES SPA.
Classification:   BONE CEMENT
Generic Device Name:   BONE CEMENT
Proprietary Device Name:   CEMEX
Registered Establishment Name:  TECRES SPA.
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   CEMENT MIXING BOWL WITH SPATULA
Proprietary Device Name:   CEMENT MIXING BOWL WITH SPATULA
Registered Establishment Name:  TECRES SPA.
Classification:   DISPENSER, CEMENT
Generic Device Name:   CEMENT DISPENSER
Proprietary Device Name:   GUN APPLICATION DEVICE
Registered Establishment Name:  TECRES SPA.
Classification:   TEMPLATE
Generic Device Name:   X-RAY TEMPLATE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TECRES SPA.
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Generic Device Name:   TEMPORARY HIP SPACER
Proprietary Device Name:   SPACER G
Registered Establishment Name:  TECRES SPA.

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Last Modified: 29 April 2006
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