FDA applicant
Guangzhou Zhengkang Medical Equipment Co.,Ltd
FDA records 2 decisions for Guangzhou Zhengkang Medical Equipment Co.,Ltd (Guangzhou, CN) from 2021 to 2022: 2 510(k) clearances. All are in product code FXX (Mask, Surgical). 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
How often FDA has decided Guangzhou Zhengkang Medical Equipment Co.,Ltd’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
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