BEUDAMED
    9 results · 35ms · Sources: EU EUDAMED, US FDA

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    Single-use Ureteral Access Sheath

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

    NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    iSy Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 30, 2024

    CONTOUR

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE LLC·Product code NBW·November 14, 2014

    MP50 INTELLIVUE PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 10, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 29, 2013

    DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·November 3, 2019

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017