FDA applicant

Irex Corp.

Mchenry, IL10 decisions1977–19850 recalls

FDA records 10 decisions for Irex Corp. (Mchenry, IL) from 1977 to 1985: 10 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and DXK (Echocardiograph). 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 Irex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Irex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Irex Corp.

Which product codes does it file in?

What has FDA decided for it lately?