BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    CIRRUS HD-OCT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ZOLL IVTM ICY CATHETER

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code NCX·August 24, 2023

    CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM

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

    ABACUS 3CP

    FDA 510(k)
    FDA Class 2 ·Hematology

    IDRT, UNKNOWN

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORP.·Product code MGR·June 17, 2013

    STERI-PROBE

    FDA Adverse Event
    Malfunction ·CINCINNATI SUB-ZERO·Product code FLL·July 25, 2011

    ACCU-CHEK ACTIVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 25, 2008

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code LWR·September 2, 2022

    ZOLL IVTM ICY CATHETER

    FDA Adverse Event
    Injury ·ZOLL CIRCULATION INC·Product code NCX·June 22, 2023

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 12, 2015

    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 13, 2022