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

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    LIFEPATCH ECG ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 5, 2014

    EXTERNAL PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012

    OT ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 10, 2010

    B125M Patient Monitor, REF 6160000-005-XXXXXXX

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022