BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    FLOWMETER, BACK PRESSURE COMPENSATED,

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Pure Vu System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HEALTHANYWHERE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 5, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 15, 2012

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·August 2, 2010

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025