FDA applicant
Medtronic Powered Surgical Solutions
FDA records 9 decisions for Medtronic Powered Surgical Solutions (Fort Worth, TX) from 2007 to 2021: 9 510(k) clearances. Most are in product codes HBC (Motor, Drill, Electric) and HBB (Motor, Drill, Pneumatic). Since 2016 its 510(k)s took a median of 72 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 10 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medtronic Powered Surgical Solutions’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medtronic Powered Surgical Solutions’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