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

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    SUREFIRE GUIDE SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045920·Barrel Shaver, 6mm

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642105124·PS3 Screw 7.5mm x 35mm

    MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON

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

    OMNI II PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2026

    NITE GUARD

    FDA Adverse Event
    Malfunction ·RANIR LLC·Product code OBR·May 1, 2014

    ONYX

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code MFE·May 15, 2013

    ACTIVA RC

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·June 2, 2011

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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