BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ELECTRODE PACEMAKER, PERM & TEMP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CO2 LAPAROSCOPE

    FDA 510(k)

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 3, 2014

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·November 12, 2012

    TRIATHLON-CR FEMORAL COMPONENT/CEMENTED #3 LEFT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·September 20, 2010

    PINPOINT Endoscopic Fluorescence Imaging System

    FDA Recall
    Terminated ·Novadaq Technologies Inc.·Product code GCJ·January 29, 2016

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018