510(k) Report

FDA applicant

Advanced Medical Design Co., Ltd.

New Taipei City, TW2 decisions2019–20210 recalls

FDA records 2 decisions for Advanced Medical Design Co., Ltd. (New Taipei City, TW) from 2019 to 2021: 2 510(k) clearances. Most are in product codes OCT (Anti Fog Solution And Accessories, Endoscopy) and GCJ (Laparoscope, General & Plastic Surgery). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Advanced Medical Design Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019: 12021: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Advanced Medical Design Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OCTAnti Fog Solution And Accessories, Endoscopy1decision
  • GCJLaparoscope, General & Plastic Surgery1decision

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?

  • K210248Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021
  • K181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd. · 2019

All 2 as Advanced Medical Design Co., Ltd. →