BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    ORTHOPAEDIC WIRES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GYNECARE PROLENE FASTENER SYSTEM

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

    Stryker Precision HD Camera System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·December 30, 2010

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·February 4, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER MANUFACTURING FACILITY·Product code FKX·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