BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    CYSTO-AID

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VERTE-STACK K030736, K041197

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019

    DeepRhythmAI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO VERTE-STACK SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CORNERSTONE-SR CAGE SYSTEM

    FDA Adverse Event
    Death ·MSD DEGGENDORF MFG·Product code ODP·February 17, 2012

    PROG VALVE RIGHT ANGLE

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·January 13, 2021

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 30, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 21, 2012

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·September 13, 2010

    PROG VALVE RIGHT ANGLE

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·January 13, 2021

    Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·July 23, 2025