FDA applicant

Axiom Ent. Co., Ltd.

Kaohsiung, TW1 decision1994–19940 recalls

FDA records 1 decision for Axiom Ent. Co., Ltd. (Kaohsiung, TW) in 1994: 1 510(k) clearance. All are in product code HQY (Sunglasses (Non-Prescription Including…). 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 Axiom Ent. Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Axiom Ent. Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Axiom”

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

Axiom Medical, Inc. 28 Axiom Worldwide, Inc. 4 Axiom, Inc. 4 Axiom Usa., Inc. 4 Axiom Manufacturing 2 Axiom Orthopaedics, Inc. 1 Axiom Technology Partners, LLC 1

Axiom Ent. Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Axiom”