510(k) Report

FDA applicant

Cardiac Recorders, Ltd.

London, GB8 decisions1985–19870 recalls

FDA records 8 decisions for Cardiac Recorders, Ltd. (London, GB) from 1985 to 1987: 8 510(k) clearances. Most are in product codes DRT (Monitor, Cardiac (Incl. Cardiotachometer &…) and LDD (Dc-Defibrillator, Low-Energy, (Including…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Cardiac Recorders, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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