FDA applicant
Merit Medical Ireland, Ltd.
FDA records 6 decisions for Merit Medical Ireland, Ltd. (Galway, IE) from 2012 to 2026: 6 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and MAV (Syringe, Balloon Inflation). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Merit Medical Ireland , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Merit Medical Ireland, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2016
Class I Class II/III not classified
Planning a device like Merit Medical Ireland, Ltd.’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 “Merit”
FDA records each applicant name separately; these may or may not be the same firm.