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

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    OmniTom Elite

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 25, 2011

    TVL LEAD, RIGHT VENTRICULAR

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

    4000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·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