FDA applicant
Medtronic, Ireland
FDA records 13 decisions for Medtronic, Ireland (Galway, IE) from 1980 to 2026: 9 510(k) clearances and 4 original PMA approvals. Most are in product codes LOX (Catheters, Transluminal Coronary Angioplasty…) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 156 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Medtronic Ireland”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medtronic, Ireland’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medtronic, Ireland’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