BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Erchonia FX-405

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BLACKHAWK Cervical Spacer System

    FDA UDI
    Choice Spine, LP·00840996164696·BLACKHAWK,STERILE,CONVEX,14X12X9

    URINARY CATHETERS

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

    CAS PSI KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 18, 2011

    HIRES 90K ADVANTAGE IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·July 15, 2013

    ACCOLADE DR SL MRI (Model L311)

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