510(k) Report

FDA applicant

Ding Hwa Co., Ltd.

Buffalo, NY5 decisions2008–20180 recalls

FDA records 5 decisions for Ding Hwa Co., Ltd. (Buffalo, NY) from 2008 to 2018: 5 510(k) clearances. All are in product code JCX (Apparatus, Suction, Ward Use, Portable…). Its devices cite 5 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 Ding Hwa Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2008: 12013: 12014: 22018: 1
2008high 2 (2014) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Ding Hwa Co., Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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