BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    TANTHERA-T35

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

    CoughAssist

    FDA UDI
    Respironics, Inc.·00606959021204·CoughAssist 70 Series Circuit, Toddler, 6ft

    AVIATOR PERIPHERAL DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STAT-SHELL DISPOSABLE SP02 SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code MTA·May 2, 2013

    ZOLL IVTM THERMOGARD XP

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC·Product code NCX·September 15, 2014

    CLARION

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·May 10, 2011

    INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·December 2, 2013

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018