6 results
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49ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
FDA Recall
Open, Classified
·Fujifilm Medical Systems U.S.A., Inc.·Product code LLZ·March 2, 2021