510(k) Report

FDA applicant

Sinclair Pharmaceuticals, Ltd.

Godalming, Surrey, GB10 decisions2001–20060 recalls

FDA records 10 decisions for Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB) from 2001 to 2006: 9 510(k) clearances and 1 De Novo grant. Most are in product codes OLR (Oral Wound Dressing) and NTO (Rinse, Oral, Antibacterial (By Physical Means)). Its devices cite 14 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sinclair Pharmaceuticals Limited”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Sinclair Pharmaceuticals, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sinclair Pharmaceuticals, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sinclair Pharmaceuticals, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sinclair 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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Other applicant names beginning “Sinclair”

FDA records each applicant name separately; these may or may not be the same firm.