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

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    VS Newborn Heart Rate Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OPTISENSE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    CLEANIC

    FDA Adverse Event
    Injury ·KERRHAWE·Product code EJR·July 2, 2013

    HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·October 24, 2018

    EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·November 8, 2018

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021