3 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
FDA Recall
Terminated
·Mazor Robotics Ltd·Product code HAW·November 26, 2014
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
FDA Enforcement
Class II
·Terminated·Mazor Robotics Ltd·December 26, 2018
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
FDA Enforcement
Class II
·Terminated·Mazor Robotics Ltd·January 1, 2020