BEUDAMED
    9 results · 31ms · Sources: EU EUDAMED, US FDA

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    AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PATELLA CLAMP ASSEMBLY

    FDA UDI
    Conformis, Inc.·00810933030247·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105070·Draw Rod, Primal T- Handle

    VISTAKON (METHAFILCON A) CONTACT LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAVERMAP SURGICAL AID

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code BTI·April 26, 2013

    LIGHTSPEED VCT

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS LLC·Product code JAK·April 22, 2011

    GORE HELEX SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MLV·July 22, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014