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

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    LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X380MM X 12

    FDA Adverse Event
    Injury ·STRYKER TRAUMA GMBH·Product code HSB·October 30, 2012

    VIEWFLEX XTRA ICE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO V-CATH POLY PICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·November 12, 2008

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·September 4, 2011

    POWER PORT M.R.I. IMPLANTABLE PORT

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS·Product code LJT·July 12, 2013

    ACCOLADE DR SL MRI (Model L311)

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