BEUDAMED
    4 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Iii × Clear all

    Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797

    FDA Enforcement
    Class III ·Ongoing·Volcano Corp·July 6, 2022

    Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

    FDA Enforcement
    Class III ·Ongoing·Volcano Corp·July 6, 2022

    IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

    FDA Enforcement
    Class III ·Ongoing·Volcano Corp·April 20, 2022

    MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems

    FDA Enforcement
    Class III ·Ongoing·Volcano Corp·April 20, 2022