FDA applicant

Unimar, Inc.

Wilton, CT10 decisions1981–19943 recalls

FDA records 10 decisions for Unimar, Inc. (Wilton, CT) from 1981 to 1994: 10 510(k) clearances. Most are in product codes HES (Insufflator, Carbon-Dioxide, Uterotubal (And…) and EYY (Drape, Urological, Disposable). 3 recalls are 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 Unimar, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Unimar, Inc. since 2007.

Recalls per year

3in 2025

2007high 3 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

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Unimar, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?