BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INDIGO SYSTEM ASPIRATION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DXE·August 11, 2020

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 23, 2011

    2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·June 17, 2013

    CNS-9700

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP·Product code MHX·September 10, 2014

    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