FDA applicant
Medtronic, Inc.
FDA records 290 decisions for Medtronic, Inc. (Mounds View, MN) from 1981 to 2026: 248 510(k) clearances and 42 original PMA approvals. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and MXD (Recorder, Event, Implantable Cardiac, (With…). Since 2016 its 510(k)s took a median of 80 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 466 predicates, 147 of them its own earlier devices. 485 recalls are linked to its devices, 260 Class I.
FDA’s records also spell it “Medtronic”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medtronic, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
8in 2025
2026 so far, outlined.
Recalls per year
14in 2026
Class I Class II/III not classified
Planning a device like Medtronic, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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