510(k) Report

FDA applicant

Orthos Limited

Bristol, North Somerset, GB1 decision2006–20060 recalls

FDA records 1 decision for Orthos Limited (Bristol, North Somerset, GB) in 2006: 1 510(k) clearance. All are in product code FMF (Syringe, Piston). No 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 hospital panel, where it files most

How often FDA has decided Orthos Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthos Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Orthos”

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