510(k) Report

FDA applicant

Secure Scientific Sdn Bhd

Lunas, Kedah, MY1 decision2003–20030 recalls

FDA records 1 decision for Secure Scientific Sdn Bhd (Lunas, Kedah, MY) in 2003: 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 Secure Scientific Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Secure Scientific Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Secure”

FDA records each applicant name separately; these may or may not be the same firm.