510(k) Report

FDA applicant

Convida Healthcare & Systems Corporation

Taoyuan County, TW2 decisions2013–20140 recalls

FDA records 2 decisions for Convida Healthcare & Systems Corporation (Taoyuan County, TW) from 2013 to 2014: 2 510(k) clearances. All are in product code FSY (Light, Surgical, Ceiling Mounted). Its devices cite 2 predicates, 1 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 Convida Healthcare & Systems Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013: 12014: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Convida Healthcare & Systems Corporation by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FSYLight, Surgical, Ceiling Mounted2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132307Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 20131cites it

What has FDA decided for it lately?

  • K140930Vida Led Surgical Lighting System, V SeriesConvida Healthcare & Systems Corporation · 2014
  • K132307Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013

All 2 as Convida Healthcare & Systems Corporation →