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

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    Pulse Oximeter (Model C101A2, C101B1, C101A3)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PASS OCT SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMISSON STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 17, 2011

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·November 3, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 3, 2013

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025