BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    PRONTO DRY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Monolith

    FDA UDI
    Nuvasive, Inc.·00887517697943·Monolith Core, Ø12x48mm

    MAXEMS, MODELS 1000 AND 2000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SECUTE ELBOW BAND

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·March 6, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·August 8, 2014

    ANGIOSCULPT PTA SCORING BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC.·Product code LIT·January 28, 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

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024