FDA applicant

Qmed, Inc.

Louisville, KY11 decisions1984–19980 recalls

FDA records 11 decisions for Qmed, Inc. (Louisville, KY) from 1984 to 1998: 11 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and GXY (Electrode, Cutaneous). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Qmed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Qmed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Qmed, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?