FDA applicant
Vivasure Medical Limited
FDA records 2 decisions for Vivasure Medical Limited (Galway, IE) from 2025 to 2026: 1 510(k) clearance and 1 original PMA approval. Most are in product codes DYB (Introducer, Catheter) and MGB (Device, Hemostasis, Vascular). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Vivasure Medical , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vivasure Medical Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Vivasure Medical Limited’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