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

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    ULTRACLONE ECL-01-1100

    FDA 510(k)
    FDA Class 1 ·Hematology

    ATRICURE BIPOLAR SYSTEM

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

    NuVasive Sterilization Trays

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DQO·June 2, 2014

    SCD 700 COMPRESSION SYSTEM - US

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code JOW·October 24, 2012

    PATIENT ROOM WALL SAVER RECL

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FRK·September 10, 2010

    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024