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FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories4
Latest FDA decision2025-05-29
TypeNumberDevice NameCodeDateActions
510(k) K250307 Visualase V2 MRI-guided Laser Ablation System (9736422)ONO2025-05-29 View
510(k) K212397 StealthStation S8 Cranial v2.0HAW2021-12-22 View
510(k) K211442 StealthStation Spinous Process ClampsOLO2021-07-08 View
510(k) K201327 NavLock TrackersOLO2020-06-18 View
510(k) K193579 PlasmaBlade X 3.0S LIGHTGEI2020-03-24 View
510(k) K182104 NavLock Trackers, Robotic Reference FrameOLO2018-11-02 View
510(k) K180816 Ziehm RFD 3D TrackerOLO2018-07-11 View
510(k) K171267 NavLock TrackersOLO2017-07-03 View
510(k) K170011 StealthStation S8 Spine Software v1.0.0OLO2017-05-01 View
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