FDA applicant
Marvao Medical Devices, Ltd.
FDA records 9 decisions for Marvao Medical Devices, Ltd. (Galway, IE) from 2011 to 2022: 9 510(k) clearances. Most are in product codes MSD (Catheter, Hemodialysis, Implanted) and LJS (Catheter, Intravascular, Therapeutic…). Its devices cite 16 predicates, 10 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Marvao Medical Devices, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Marvao Medical Devices, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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