8 results
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65ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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Mazor Robotics Ltd.
Manufacturer
🇮🇱 Israel·1 Importer
MAZOR ROBOTICS LTD.
FDA registration
MAZOR ROBOTICS LTD.·3 products·🇮🇱 Israel
Mazor X robotic guidance system REF: TPL0059
FDA Enforcement
Class II
·Ongoing·Mazor Robotics Ltd·January 28, 2026
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
FDA Enforcement
Class II
·Ongoing·Mazor Robotics Ltd·September 25, 2024
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
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
FDA Enforcement
Class II
·Ongoing·Mazor Robotics Ltd·October 18, 2023
Mazor Robotics Ltd.
System producer
🇮🇱 Israel