FDA applicant
Advanced Medical Solutions Limited
FDA records 23 decisions for Advanced Medical Solutions Limited (Winsford, Cheshire, GB) from 2001 to 2023: 22 510(k) clearances and 1 original PMA approval. Most are in product codes FRO (Dressing, Wound, Drug) and MPN (Tissue Adhesive For The Topical Approximation…). Since 2016 its 510(k)s took a median of 151 days from receipt to decision, against 270 for FDA’s reviews in the same codes and years. Its devices cite 37 predicates, 18 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Advanced Medical Solutions, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Advanced Medical Solutions Limited’s devices, and how often a recall has named them.
FDA decisions per year
3in 2023
2026 so far, outlined.
Recalls per year
2in 2022
Class I Class II/III not classified
Planning a device like Advanced Medical Solutions Limited’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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