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

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    Surgical Mask

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

    COLLATEK FOAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    HD-IVUS ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIPOLAR ENDOCARDIAL LEAD

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS·Product code DTB·January 9, 1997

    SWEET TIP BIPOLAR LEAD

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS·Product code DXY·January 9, 1997

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

    COROX OTW-L 85-BP

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NKE·August 9, 2011

    THINLINE

    FDA Adverse Event
    Malfunction ·GUIDANT ANGLETON/ST. PAUL·Product code NVN·July 9, 2013

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023