BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CT5137 HIGH RESOLUTION OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·February 27, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·February 7, 2011

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Death ·EV3 NEUROVASCULAR·Product code OUT·August 5, 2014

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021