FDA applicant
Sauflon Pharmaceuticals, Ltd.
FDA records 12 decisions for Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB) from 1999 to 2014: 12 510(k) clearances. Most are in product codes LPN (Accessories, Soft Lens Products) and LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 14 predicates, 2 of them its own earlier devices. 18 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sauflon Pharmaceuticals, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Sauflon Pharmaceuticals, 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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