FDA applicant

Medgyn Products, Inc.

Downers Grove, IL5 decisions1988–20150 recalls

FDA records 5 decisions for Medgyn Products, Inc. (Downers Grove, IL) from 1988 to 2015: 5 510(k) clearances. Most are in product codes HEX (Colposcope (And Colpomicroscope)) and HDY (Dilator, Cervical, Hygroscopic-Laminaria). Its devices cite 3 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 Medgyn Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Medgyn Products, 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?