BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    MICROFLEX

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Viberect Penile Vibratory Stimulation Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·January 8, 2013

    1:1 CONTRA ANGLE HEAD W/INTERNAL IRRIGATION

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HWE·December 22, 2010

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 17, 2014

    2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010