BEUDAMED
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    Portux CAD/CAM Disc

    FDA 510(k)
    FDA Class 2 ·Dental

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583033037·ET20, KIT 312 NFM 90 L BE ENCHANT 20

    MOBIUS ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SKYLINE 55, MODEL VER 1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDFUSION 3500 PUMP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·April 17, 2023

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

    PLV-100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·June 20, 2013

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·August 4, 2011

    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    FDA Enforcement
    Class III ·Terminated·Invivo Corporation·October 28, 2020