510(k) Report

FDA applicant

Union Industrial Co., Ltd.

Tainan, TW3 decisions1989–19950 recalls

FDA records 3 decisions for Union Industrial Co., Ltd. (Tainan, TW) from 1989 to 1995: 3 510(k) clearances. Most are in product codes HQY (Sunglasses (Non-Prescription Including…) and IMM (Footrest, Wheelchair). 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 Union Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Union Industrial Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Union Industrial Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Union Industrial Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Union”

FDA records each applicant name separately; these may or may not be the same firm.