510(k) Report

FDA applicant

North Eos Industries, Inc.

Taichung Hsien 423, TW3 decisions1996–19960 recalls

FDA records 3 decisions for North Eos Industries, Inc. (Taichung Hsien 423, TW) in 1996: 3 510(k) clearances. Most are in product codes HIB (Speculum, Vaginal, Nonmetal) and HHT (Spatula, Cervical, Cytological). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided North Eos Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for North Eos Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — North Eos Industries, Inc. 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?

  • HIBSpeculum, Vaginal, Nonmetal1decision
  • HHTSpatula, Cervical, Cytological1decision
  • GCPEndoscope, Ac-Powered And Accessories1decision

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.

  • K954614Eos Brand Disposable ProctoscopeNorth Eos Industries, Inc. · 19961cites it

What has FDA decided for it lately?

  • K963685Eos Brand Disposable Cyto/Cervical SamplerNorth Eos Industries, Inc. · 1996
  • K963377Eos Brand Disposable Vaginal Speculum-EosspecNorth Eos Industries, Inc. · 1996
  • K954614Eos Brand Disposable ProctoscopeNorth Eos Industries, Inc. · 1996

All 3 as North Eos Industries, Inc. →