BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BTL-094

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    VISUAL-ICE CRYOABLATION SYSTEM

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

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MFG.·Product code LKK·August 18, 2011

    QUICKSITE XL LV

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

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·July 2, 2013

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

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