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

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    MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE

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

    Vis-U-All Low Temperature Sterilization Pouch/Tubing

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PITT-EASY DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 28, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 2, 2011

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 6, 2014

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020