FDA applicant
Depuy Ireland UC
FDA records 50 decisions for Depuy Ireland UC (Ringaskiddy, IE) from 2018 to 2026: 50 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and LZO (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 101 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 220 predicates, 36 of them its own earlier devices. 21 recalls are linked to its devices.
FDA’s records also spell it “DePuy Ireland UC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Depuy Ireland UC’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
11in 2026
Class I Class II/III not classified
Planning a device like Depuy Ireland UC’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) ReportOther applicant names beginning “Depuy”
FDA records each applicant name separately; these may or may not be the same firm.