FDA applicant
Medtronic Navigation, Inc.
FDA records 44 decisions for Medtronic Navigation, Inc. (Louisville, CO) from 2005 to 2026: 44 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 73 predicates, 35 of them its own earlier devices. 36 recalls are linked to its devices, 7 Class I.
FDA’s records also spell it “Medtronic Navigation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medtronic Navigation, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Medtronic Navigation, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report