510(k) Report

FDA applicant

Taiwan Eva Industrial Co., Inc.

Kaohsiung, TW3 decisions1994–19950 recalls

FDA records 3 decisions for Taiwan Eva Industrial Co., Inc. (Kaohsiung, TW) from 1994 to 1995: 3 510(k) clearances. Most are in product codes HQY (Sunglasses (Non-Prescription Including…) and HOY (Shield, Eye, Ophthalmic (Including Sunlamp…). 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, ophthalmic panel, where it files most

How often FDA has decided Taiwan Eva Industrial Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Taiwan Eva Industrial Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Taiwan Eva Industrial Co., 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?

  • HQYSunglasses (Non-Prescription Including Photosensitive)1decision
  • HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)1decision
  • HQZFrame, Spectacle1decision

What has FDA decided for it lately?

  • K952438Sunglasses (Non-Prescription Including Photosensitive)Taiwan Eva Industrial Co., Inc. · 1995
  • K945351Shield, Eye, OphthalmicTaiwan Eva Industrial Co., Inc. · 1994
  • K945350Frame, SpectaclesTaiwan Eva Industrial Co., Inc. · 1994

All 3 as Taiwan Eva Industrial Co., Inc. →