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Medtronic Navigation, Inc.

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories6
Latest Approval2026-03-26
TypeNumberDevice NameCodeDate
510(k) K253379 Stealth AXiS Cranial clinical application HAW 2026-03-26 View
510(k) K253395 Stealth AXiS™ ENT clinical application PGW 2026-03-16 View
510(k) K253391 Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) ONO 2026-03-13 View
510(k) K253381 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application OLO 2026-02-12 View
510(k) K251282 StealthStation S8 Spine Software OLO 2025-10-17 View
510(k) K242464 Stealth™ Spine Clamps; ModuLeX™ Shank Mounts OLO 2025-06-05 View
510(k) K240465 O-arm O2 Imaging System OWB 2024-06-21 View
510(k) K231976 StealthStation Cranial Software, v3.1.5 (9735585) HAW 2023-10-19 View
510(k) K221087 Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 HAW 2022-06-10 View
510(k) K211269 Visualase MRI-Guided Laser Ablation System (SW 3.4) ONO 2022-01-07 View
510(k) K203639 StealthStation Cranial Software v1.3.2 HAW 2021-01-13 View
510(k) K200723 StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) PGW 2020-06-26 View
510(k) K201175 StealthStation Cranial Software v1.3.0 HAW 2020-06-03 View
510(k) K201189 Stealthstation S8 Spine Software v1.3.0 OLO 2020-05-29 View
510(k) K191597 Stealth Autoguide System, Midas Rex Legend Depth Stop System HAW 2019-11-01 View
510(k) K190672 StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 HAW 2019-07-31 View
510(k) K181859 Visualase Thermal Therapy System LLZ 2019-03-06 View
510(k) K170018 StealthStationTM S8 ENT Software PGW 2017-05-19 View
510(k) K162655 StealthConnect Remote Viewing, Planning and Collaboration System HAW 2017-04-21 View
510(k) K162309 StealthStation S8 System Platforms and StealthStation Cranial Software HAW 2017-03-31 View
510(k) K162604 Cranial Reducing Tubes HAW 2016-12-30 View
510(k) K153660 StealthStation System with Cranial Software HAW 2016-09-14 View
510(k) K153555 EM ENT Navigated Suctions PGW 2016-04-07 View
510(k) K153247 Fusion Compact Navigation System PGW 2016-02-18 View
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