510(k) Report

FDA applicant

Hedonist Biochemical Technologies Co., Ltd.

Taipei, TW2 decisions2003–20040 recalls

FDA records 2 decisions for Hedonist Biochemical Technologies Co., Ltd. (Taipei, TW) from 2003 to 2004: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Hedonist Biochemical Technologies Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hedonist Biochemical Technologies Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hedonist Biochemical Technologies Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K041013Suile Ointment Wound DressingHedonist Biochemical Technologies Co., Ltd. · 20041cites it

What has FDA decided for it lately?

  • K041013Suile Ointment Wound DressingHedonist Biochemical Technologies Co., Ltd. · 2004
  • K022967Suile Wound DressingHedonist Biochemical Technologies Co., Ltd. · 2003

All 2 as Hedonist Biochemical Technologies Co., Ltd. →