BEUDAMED
    4 results · 31ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

    FDA Enforcement
    Class II ·Terminated·Synaptive Medical, Inc.·December 30, 2015

    ClearCanvas RIS/PACS

    FDA Enforcement
    Class II ·Terminated·Synaptive Medical Inc·April 29, 2020

    Synaptive ImageDrive Clinical

    FDA Enforcement
    Class II ·Terminated·Synaptive Medical Inc·April 29, 2020

    Synaptive Trackable Suction Set Standard and Malleable

    FDA Enforcement
    Class II ·Terminated·Synaptive Medical Inc·July 7, 2021