FDA applicant

Monsys USA, Inc.

Philippi, WV1 decision1996–19960 recalls

FDA records 1 decision for Monsys USA, Inc. (Philippi, WV) in 1996: 1 510(k) clearance. All are in product code LTZ (Condom With Nonoxynol-9). 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 Monsys USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Monsys USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Monsys USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?