BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    TC SYSTEM-COVER

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

    CARDIAC PULSE GENERATOR, 16 SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRILOGY 100

    FDA Adverse Event
    Injury ·RESPIRONICS INC.·Product code CBK·June 4, 2014

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·October 28, 2010

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 21, 2012

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

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