BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)

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

    COPSIOS BONE VOID FILLER (BVF)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Automatic Registration

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONTOUR® PLUS BLUE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

    XIA 3 TITANIUM ROD DIAM 6MM CP TI L 130MM

    FDA Adverse Event
    Injury ·STRYKER SPINE-SWITZERLAND·Product code MNH·July 18, 2013

    CONTOUR® PLUS BLUE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 11, 2025

    CONTOUR® CARE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 13, 2025

    CONTOUR® CARE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 7, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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