FDA applicant

Chang Gung Medical Technology Co., Ltd.

Taipei City, TW2 decisions2015–20150 recalls

FDA records 2 decisions for Chang Gung Medical Technology Co., Ltd. (Taipei City, TW) in 2015: 2 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and DZE (Implant, Endosseous, Root-Form). Its devices cite 2 predicates, 0 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, radiology panel, where it files most

How often FDA has decided Chang Gung Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Chang Gung Medical Technology Co., Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Chang Gung Medical Technology 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 “Chang”

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

Chang Gung Medical Supplies & Equipment Corp. 1 Chang Gung Medical Technology Co., Ltd. Linkou Fac 1

Chang Gung Medical Technology Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Chang”