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

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    ONE-WAY AIR VALVE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EASY MED TN-28 C

    FDA 510(k)
    FDA Class 2 ·Neurology

    MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE

    FDA 510(k)
    FDA Class 2 ·Radiology

    REMB UNIVERSAL DRIVER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·May 30, 2014

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    FDA Adverse Event
    Malfunction ·ACCESSCLOSURE, INC.·Product code MGB·May 24, 2012

    AUTOTOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·September 21, 2010

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025