BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEM, MODEL 004110

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION

    FDA 510(k)
    FDA Class 2 ·Immunology

    VALIANT CAPTIVIA

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·May 24, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 16, 2011

    PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP

    FDA Adverse Event
    Injury ·PONCE-USS·Product code GDW·August 20, 2008

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·October 30, 2017

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 9, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·February 28, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 8, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·April 25, 2018

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024