Medtronic Navigation, Inc. - FDA 510(k) Cleared Devices
34
Total
34
Cleared
0
Denied
Medtronic Navigation, Inc. has 34 FDA 510(k) cleared medical devices. Based in Lafayette, US.
Latest FDA clearance: Mar 2026. Active since 2005. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Medtronic Navigation, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Medtronic Navigation, Inc.
34 devices
Cleared
Mar 16, 2026
Stealth AXiS™ ENT clinical application
Ear, Nose, Throat
167d
Cleared
Mar 13, 2026
Visualase Cooled Laser Applicator System (9735559)
Neurology
164d
Cleared
Feb 12, 2026
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
Orthopedic
135d
Cleared
Oct 17, 2025
StealthStation S8 Spine Software
Orthopedic
176d
Cleared
Jun 05, 2025
Stealth™ Spine Clamps
Orthopedic
290d
Cleared
Jun 21, 2024
O-arm O2 Imaging System
Radiology
126d
Cleared
Oct 19, 2023
StealthStation Cranial Software, v3.1.5 (9735585)
Neurology
108d
Cleared
Jun 10, 2022
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
Neurology
58d
Cleared
Jan 07, 2022
Visualase MRI-Guided Laser Ablation System (SW 3.4)
Neurology
255d
Cleared
Jan 13, 2021
StealthStation Cranial Software v1.3.2
Neurology
30d
Cleared
Jun 26, 2020
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
Ear, Nose, Throat
99d
Cleared
Jun 03, 2020
StealthStation Cranial Software v1.3.0
Neurology
33d