BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    InkSpace Imaging Small Body Array

    FDA 510(k)
    FDA Class 2 ·Radiology

    FORE-SIGHT Elite Absolute Tissue Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MP Reconstruction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TOP END·Product code IOR·November 11, 2014

    MAESTRO PERFORATOR CHUCK

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBB·July 28, 2011

    MULTI-MED CENTRAL VENOUS CATHETER SET WITH AMC THROMBOSHIELD

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code FOZ·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025