BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    Digital Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    S12X WITH ESAX OPTION

    FDA 510(k)
    FDA Class 2 ·Neurology

    ONSET ACCESS CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022

    POLYMOBIL PLUS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 21, 2013

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIM·July 28, 2011

    MOBILETT ELARA MAX

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020

    PANTHER FUSION ADV/HMPV/RV ASSAY

    FDA Adverse Event
    Injury ·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021