FDA applicant

Medilatex Sdn. Bhd.

Kulai, Johor, MY1 decision1999–19990 recalls

FDA records 1 decision for Medilatex Sdn. Bhd. (Kulai, Johor, MY) in 1999: 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 Medilatex Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medilatex Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Medilatex Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?