FDA applicant

The Female Health Co.

Chicago2 decisions1993–19950 recalls

FDA records 2 decisions for The Female Health Co. (Chicago) from 1993 to 1995: 2 original PMA approvals. All are in product code MBU (Single-Use Internal Condom). 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 The Female Health Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Female Health Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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The Female Health Co.

Which product codes does it file in?

What has FDA decided for it lately?