Medtronic Navigation, Inc.
FDA 510(k) & PMA Approved Devices — 24 products
Total Devices24
Categories6
Latest FDA decision2026-03-26
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 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 |
No matching devices.
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