BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    Insulia Diabetes Management Companion

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oticon

    FDA UDI
    Oticon A/S·05707131305510·SENSEI SP, BTE 13 WL 110 AQM TAR

    VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEPUY ATTUNE KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GOLDTRACE

    FDA Adverse Event
    Malfunction ·CLINICAL INNOVATIONS, LLC·Product code HGP·December 11, 2017

    GOLDTRACE

    FDA Adverse Event
    Malfunction ·CLINICAL INNOVATIONS, LLC·Product code HGP·December 11, 2017

    GOLDTRACE

    FDA Adverse Event
    Malfunction ·CLINICAL INNOVATIONS, LLC·Product code HGP·December 11, 2017

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 13, 2011

    DUAL EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·September 17, 2008

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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