Medtronic Navigation, Inc.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Medtronic Navigation, Inc.” (first 2005, latest 2026), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 123 days. Since 2017 the median was 126 days, against 113 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 89 |
| 2014 | 2 | 180 |
| 2015 | 2 | 196 |
| 2016 | 4 | 108 |
| 2017 | 5 | 136 |
| 2018 | 2 | 98 |
| 2019 | 3 | 138 |
| 2020 | 5 | 33 |
| 2021 | 3 | 59 |
| 2022 | 2 | 156 |
| 2023 | 1 | 108 |
| 2024 | 1 | 126 |
| 2025 | 3 | 176 |
| 2026 | 4 | 166 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medtronic Navigation, Inc. took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 19 | 19 |
| OLO | Orthopedic Stereotaxic Instrument | 12 | 12 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 6 | 6 |
| ONO | Neurosurgical Laser With Mr Thermography | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
Review panels
- Neurology (22)
- Orthopedic (12)
- Ear, Nose and Throat (6)
- Radiology (3)
- General and Plastic Surgery (1)
Most recent Medtronic Navigation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253379 | Stealth AXiS Cranial clinical application | HAW | 2026-03-26 | 177 |
| K253395 | Stealth AXiS ENT clinical application | PGW | 2026-03-16 | 167 |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | ONO | 2026-03-13 | 164 |
| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | OLO | 2026-02-12 | 135 |
| K251282 | StealthStation S8 Spine Software | OLO | 2025-10-17 | 176 |
| K242464 | Stealth Spine Clamps; ModuLeX Shank Mounts | OLO | 2025-06-05 | 290 |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | ONO | 2025-05-29 | 115 |
| K240465 | O-arm O2 Imaging System | OWB | 2024-06-21 | 126 |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | HAW | 2023-10-19 | 108 |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | HAW | 2022-06-10 | 58 |
34 earlier clearances. See the full list in Caduvo.
Recalls
109 product recalls in 60 recall events; 13 initiated in the last five years. Most recent: 2024-12-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
- Medtronic Bio-Medicus, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Navigation, Inc.?
FDA lists 44 510(k) clearances under the applicant name “Medtronic Navigation, Inc.” (first 2005, latest 2026), across 7 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medtronic Navigation, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Navigation, Inc. is 123 days. Since 2017: 126 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medtronic Navigation, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 19); OLO (Orthopedic Stereotaxic Instrument, 12); PGW (Ear, Nose, And Throat Stereotaxic Instrument, 6).
Next steps
- See all 44 Medtronic Navigation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Medtronic Navigation, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.