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Medtronic Navigation, Inc. FDA Approvals
0 new drug approvals and 11 device clearances on file. Matched by name to MDT.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Stealth AXiS Cranial clinical application510(k)Mar 26, 2026Neurology |
| Stealth AXiS ENT clinical application510(k)Mar 16, 2026Neurology |
| Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)510(k)Mar 13, 2026General, Plastic Surgery |
| Stealth AXiS Surgical System with Stealth AXiS Spine clinical application510(k)Feb 12, 2026Neurology |
| StealthStation S8 Spine Software510(k)Oct 17, 2025Neurology |
| Stealth Spine Clamps; ModuLeX Shank Mounts510(k)Jun 5, 2025Neurology |
| O-arm O2 Imaging System510(k)Jun 21, 2024Radiology |
| StealthStation Cranial Software, v3.1.5 (9735585)510(k)Oct 19, 2023Neurology |
| Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4510(k)Jun 10, 2022Neurology |
| Visualase MRI-Guided Laser Ablation System (SW 3.4)510(k)Jan 7, 2022General, Plastic Surgery |
| StealthStation Cranial Software v1.3.2510(k)Jan 13, 2021Neurology |