510(k) Report

FDA applicant

Merlin Medical Limited

United Kingdom, GB2 decisions2004–20040 recalls

FDA records 2 decisions for Merlin Medical Limited (United Kingdom, GB) in 2004: 2 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and CBP (Valve, Non-Rebreathing). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Merlin Medical Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Merlin Medical 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 “Merlin”

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