FDA applicant

Diagnosis Related Systems, Inc.

Hialeah, FL1 decision1988–19880 recalls

FDA records 1 decision for Diagnosis Related Systems, Inc. (Hialeah, FL) in 1988: 1 510(k) clearance. All are in product code HEK (Monitor, Heart Sound, Fetal, Ultrasonic). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Diagnosis Related Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diagnosis Related Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Diagnosis Related Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?