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

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    SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEOMED SINGLE LUMEN UMBILICAL CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Rusch Intermittent Urethral Catheters

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

    CAPIOX HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 19, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 1, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 19, 2011

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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