BEUDAMED
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    BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.

    FDA Recall
    Terminated ·Synaptive Medical Inc·Product code HAW·October 9, 2018

    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 Recall
    Terminated ·Synaptive Medical, Inc.·Product code HAW·December 4, 2015

    ClearCanvas RIS/PACS

    FDA Recall
    Terminated ·Synaptive Medical Inc·Product code LLZ·February 26, 2020

    Synaptive ImageDrive Clinical

    FDA Recall
    Terminated ·Synaptive Medical Inc·Product code LLZ·February 26, 2020

    Synaptive Trackable Suction Set Standard and Malleable

    FDA Recall
    Terminated ·Synaptive Medical Inc·Product code GCX·April 23, 2021

    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

    BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.

    FDA Enforcement
    Class I ·Terminated·Synaptive Medical Inc·December 5, 2018

    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