FDA applicant
Proverum Limited
FDA records 2 decisions for Proverum Limited (Dublin 1, IE) in 2025: 1 510(k) clearance and 1 original PMA approval. Most are in product codes FET (Endoscopic Video Imaging System/Component…) and MER (Stent, Urethral, Prostatic, Permanent Or…). 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 “Proverum, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Proverum Limited’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 2025.
Planning a device like Proverum 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