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

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    STATVIEW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix

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

    CHROMOPHARE E 668

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MOSAIC ULTRA PORCINE HEART VALVE

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code LWR·March 5, 2013

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    ATTAIN PERFORMA

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·August 7, 2014

    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

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025