FDA applicant

Cardionostics, Inc.

Tustin, CA4 decisions1984–19900 recalls

FDA records 4 decisions for Cardionostics, Inc. (Tustin, CA) from 1984 to 1990: 4 510(k) clearances. All are in product code DSH (Recorder, Magnetic Tape, Medical). 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 Cardionostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardionostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Cardionostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?