FDA applicant

Glimex Corp.

Folsom, CA1 decision1998–19980 recalls

FDA records 1 decision for Glimex Corp. (Folsom, CA) in 1998: 1 510(k) clearance. All are in product code HIS (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 Glimex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Glimex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Glimex Corp.

Which product codes does it file in?

What has FDA decided for it lately?