FDA applicant
Yian Medical Technology (Haining) Co., Ltd.
FDA records 4 decisions for Yian Medical Technology (Haining) Co., Ltd. (Haining, Jiaxing, CN) from 2022 to 2025: 4 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and IZL (System, X-Ray, Mobile). Since 2016 its 510(k)s took a median of 42 days from receipt to decision, against 129 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 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
How often FDA has decided Yian Medical Technology (Haining) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
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