BEUDAMED
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    CT3000Pro

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

    NA

    FDA UDI
    Synthes GmbH·10886982152923·2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365115523·

    ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LERMAN & SON CRANIAL ORTHOSIS HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION SYSTEMS·Product code GZB·October 24, 2014

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 12, 2011

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·July 9, 2013

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 20, 2026