BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    TrueBeam, TrueBeam STx, Edge, VitalBeam

    FDA 510(k)
    FDA Class 2 ·Radiology

    WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEMOSIL FACTOR V DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

    RAPID RHINO EPISTAXIS DEVICE

    FDA Adverse Event
    Injury ·ARTHROCARE CORP.·Product code EMX·August 18, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 12, 2013

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026