510(k) Report

FDA applicant

Advanced Medical Solutions (Plymouth), Ltd.

Plymouth, GB5 decisions2012–20151 recall

FDA records 5 decisions for Advanced Medical Solutions (Plymouth), Ltd. (Plymouth, GB) from 2012 to 2015: 5 510(k) clearances. Most are in product codes MPN (Tissue Adhesive For The Topical Approximation…) and KMF (Bandage, Liquid). Its devices cite 9 predicates, 3 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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Advanced Medical Solutions (Plymouth), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2012: 12013: 22014: 12015: 1
2012high 2 (2013) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2012high 1 (2022) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Advanced Medical Solutions (Plymouth), Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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