BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    JIMMY JOHN III

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

    MODIFICATION TO VISITOME 20-10 MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TRUE FLOW VALVULOPLASTY PERFUSION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·May 31, 2014

    EVIA DR-T

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code DTB·November 15, 2012

    ADULT DUAL-HEATED BREATING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 26, 2010

    DEPTH GAUGE FOR SMALL SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTJ·February 1, 2023

    MENTOR TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·February 4, 2019

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017