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

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    STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGXO

    FDA UDI
    Oticon A/S·05707131261366·H110, BTE 13 WL 85 CBE AGXO

    Zavation

    FDA UDI
    Zavation LLC·00197157006204·Custom Tap/7.5mm

    SPINEANALYER MODEL SAPOC

    FDA 510(k)
    FDA Class 2 ·Radiology

    WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·June 15, 2011

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·August 22, 2008

    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