FDA applicant

Electramold

Louisville, KY1 decision2005–20050 recalls

FDA records 1 decision for Electramold (Louisville, KY) in 2005: 1 510(k) clearance. All are in product code DRX (Electrode, Electrocardiograph). 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 Electramold’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Electramold since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Electramold

Which product codes does it file in?

What has FDA decided for it lately?