510(k) Report

FDA applicant

Medtecs (Taiwan) Corp.

Taipei City, TW2 decisions2022–20220 recalls

FDA records 2 decisions for Medtecs (Taiwan) Corp. (Taipei City, TW) in 2022: 2 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FYC (Gown, Isolation, Surgical). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Medtecs (Taiwan) Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2022: 2
2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Medtecs (Taiwan) Corp. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FXXMask, Surgical1decision
  • FYCGown, Isolation, Surgical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo GownMedtecs (Taiwan) Corp. · 2022
  • K203376ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400GMedtecs (Taiwan) Corp. · 2022

All 2 as Medtecs (Taiwan) Corp. →