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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:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDICALPLASTIC.
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDICALPLASTIC.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   HALF PIN
Proprietary Device Name:   HALF PIN
Registered Establishment Name:  MEDICALPLASTIC.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   RONGEURS ORTHOPAEDIC
Registered Establishment Name:  TIMESCO OF LONDON.
Classification:   WRENCH
Generic Device Name:   OPHTHALMIC, WRENCHES
Proprietary Device Name:   DUKWORTH & KENT WRENCHES (MULTIPLE BRANDS)
Registered Establishment Name:  DUCKWORTH & KENT, LTD..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   PINCH/GRIP METER
Proprietary Device Name:   DIGITAL PINCH/GRIP ANALYSER
Registered Establishment Name:  MIE MEDICAL RESEARCH LTD..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  MIE MEDICAL RESEARCH LTD..
Classification:   GONIOMETER, AC-POWERED
Generic Device Name:   TWIN AXIS ELECTRO-GONIOMETER, SINGLE AXIS ELECTRO-GONIOMETER, TORSIOMETER
Proprietary Device Name:   XM65, XM11D, XM11DA, XM180, XM180B, 635, 211D, Z180
Registered Establishment Name:  BIOMETRICS LTD..
Classification:   PROBE
Generic Device Name:   PLASTIC DENTAL PROBE
Proprietary Device Name:   DENTANURSE SPECIAL TOOL
Registered Establishment Name:  DENTANURSE (UK) LTD..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   KIN/COM
Proprietary Device Name:   KIN/COM
Registered Establishment Name:  MEDEX SYSTEMS INTL., INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   HEAD TRACTION SET,HORIZONTAL TRACTION SET
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A.M.G.MEDICAL, INC..
Classification:   EXTRACTOR
Generic Device Name:   FERRAY EXTRACTOR
Proprietary Device Name:   FERRAY EXTRACTOR
Registered Establishment Name:  TERRAY CORP..
Classification:   BENDER
Generic Device Name:   RD 140 SURGICAL BENDER
Proprietary Device Name:   RD 140 SURGICAL BENDER
Registered Establishment Name:  TERRAY CORP..
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   ANTERIOR SPINAL FIXATION PLATE
Proprietary Device Name:   ANTERIOR SPINAL FIXATION PLATE
Registered Establishment Name:  TERRAY CORP..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   WRIST FUSION INTERNAL FIXATION PLATE
Proprietary Device Name:   CARPAL ENGAGING WRIST FUSION PLATE
Registered Establishment Name:  TERRAY CORP..
Classification:   ACCESSORIES, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  IMPERIAL ORTHOFLEX MFG., LTD..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS WATER WEIGHT BAGS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WU HO MEDICAL INSTRUMENTS MFG. CO. LTD..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   OVER DOOR CERVICAL TRACTION KIT
Proprietary Device Name:   APPARATUS, TRACTION, NON-POWERED
Registered Establishment Name:  VALENTINE INTL. LTD..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   HEAD HALTER
Proprietary Device Name:   HALTER, HEAD, TRACTION
Registered Establishment Name:  VALENTINE INTL. LTD..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   WATER WEIGHT BAG
Proprietary Device Name:   COMPONENT, TRACTION, NON-INVASIVE
Registered Establishment Name:  VALENTINE INTL. LTD..
Classification:   PROSTHESIS, LIGAMENT
Generic Device Name:   ALUMINUM REACHER
Proprietary Device Name:   E-Z REACHER
Registered Establishment Name:  VALENTINE INTL. LTD..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   EXERCISE BALLS,HAND GRIP EXERCISER
Proprietary Device Name:   DYNAMOMETER, NONPOWERED#ORTHOPEDIC
Registered Establishment Name:  VALENTINE INTL. LTD..
Classification:   BIT, DRILL
Generic Device Name:   DENTAL BURS-CONTRA ANGLE
Proprietary Device Name:   DENTAL BURS-CONTRA ANGLE
Registered Establishment Name:  FFDM-PNEUMAT.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  EFER SA.
Classification:   PROBE
Generic Device Name:   SAME
Proprietary Device Name:   PROBE
Registered Establishment Name:  POLLAK (INTL.), LTD..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   HAND-OPERATED GONIOMETER
Proprietary Device Name:   KUBO GONIOMETER
Registered Establishment Name:  NAGASHIMA MEDICAL INSTRUMENTS CO., LTD..
Classification:   GONIOMETER, AC-POWERED
Generic Device Name:   GONIOMETER WITH CONTROL BOX, ELECTRIC
Proprietary Device Name:   NAGASHIMA GM-2 ELECTRIC GONIOMETER
Registered Establishment Name:  NAGASHIMA MEDICAL INSTRUMENTS CO., LTD..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   CERAMIC PINS
Proprietary Device Name:   G-CERA CERAMIC PINS
Registered Establishment Name:  GC CORP..
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE TWISTER
Proprietary Device Name:   TWISTER, WIRE
Registered Establishment Name:  NAKADEN OVERSEAS, LIMITED.
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS MODELS OF FIBEROPTIC ARTHROSCOPES
Proprietary Device Name:   FIBEROPTIC ARTHROSCOPE
Registered Establishment Name:  KAMIYA TSUSAN KAISHA, LTD..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   TENDON STRIPPER
Proprietary Device Name:   TENDON STRIPPER
Registered Establishment Name:  TAKASAGO MED INDUSTRY CO. LTD..
Classification:   TAP, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   TAMP
Generic Device Name:   WIRE TIGHTENER
Proprietary Device Name:   WIRE TIGHTENER
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   VARIOUS SIZES OF PLATES FOR CERVICAL
Proprietary Device Name:   PLATE FOR CERVICAL VERTEBRAE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   VARIOUS SIZES AND TYPES OF ANGLED BLADE PLATES AND SPECIAL PALTES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   TEMPLATE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES BETTLACH GMBH.

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Last Modified: 29 April 2006
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