FDA applicant

Corometrics Medical Systems, Inc.

Wallingford, CT5 decisions1988–19980 recalls

FDA records 5 decisions for Corometrics Medical Systems, Inc. (Wallingford, CT) from 1988 to 1998: 5 510(k) clearances. Most are in product codes HFM (Monitor, Uterine Contraction, External (For…) and HEM (Imager, Ultrasonic Obstetric-Gynecologic). Its devices cite 2 predicates, 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Corometrics Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Corometrics Medical Systems, 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?