BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    SIMPLEX UNIVERSAL HEATED TUBING SLEEVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

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

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 12, 2014

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 8, 2010

    SHILEY DISPOSABLE CANNULA

    FDA Adverse Event
    Injury ·HENEQUEN - RX, AVENDIA HENEQUEN·Product code JOH·December 17, 2012

    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025