BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    GEMINI PET/CT IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250

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

    TI SPIRAL BLADE 90MM FOR TI RETROGRADE FEMORAL NAILS-EX

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·November 19, 2019

    M2A-MAGNUM 42-50MM TPR INSRT-6

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·April 9, 2013

    5.5MM TI CANCELLOUS LOCKING SCREW 28MM THIRD LENGTH

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code KWQ·March 29, 2011

    CONTAK RENEWAL 3

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    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