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

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    NEO Pedicle Screw System™

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·December 20, 2021

    Nisus Touch Negative Pressure Wound Therapy Pump

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDLINE SHARPS CONTAINERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CRYSTALENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB SURGICAL·Product code HQL·November 25, 2008

    UNIVERSAL HIGH TORQUE DRILL

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

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 23, 2013

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·November 18, 2021

    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