510(k) Report

FDA applicant

Megatech Scientific Pte, Ltd.

Skytech #09-03, SG1 decision2003–20030 recalls

FDA records 1 decision for Megatech Scientific Pte, Ltd. (Skytech #09-03, SG) in 2003: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). 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, general and plastic surgery panel, where it files most

How often FDA has decided Megatech Scientific Pte, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Megatech Scientific Pte, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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