BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    CYTOCLONE A & B EIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TETRIC EVOCERAM BULK FILL

    FDA 510(k)
    FDA Class 2 ·Dental

    CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·January 11, 2013

    ENDOPATH*THOR

    FDA Adverse Event
    Death ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 1, 2010

    SECUR-FIT MAX 127 #11

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·July 3, 2014

    3) Signa Advantage (K911959 Signa Advantage 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