510(k) Report

FDA applicant

St. Francis Medical Equipment Co., Ltd.

Taipei Shien, Taiwan, R.O.C., TW1 decision2001–20010 recalls

FDA records 1 decision for St. Francis Medical Equipment Co., Ltd. (Taipei Shien, Taiwan, R.O.C., TW) in 2001: 1 510(k) clearance. All are in product code FTD (Lamp, 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 St. Francis Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for St. Francis Medical Equipment Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — St. Francis Medical Equipment 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?

  • FTDLamp, Surgical1decision

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.

  • K003423ST. Francis Operating Theatre Lamp, Models OLH01-125 and LC-055St. Francis Medical Equipment Co., Ltd. · 20011cites it

What has FDA decided for it lately?

  • K003423ST. Francis Operating Theatre Lamp, Models OLH01-125 and LC-055St. Francis Medical Equipment Co., Ltd. · 2001

The one decision as St. Francis Medical Equipment Co., Ltd. →