FDA applicant
Bain Medical Equipment (Guangzhou) Co., Ltd.
FDA records 7 decisions for Bain Medical Equipment (Guangzhou) Co., Ltd. (Guangzhou, CN) from 2017 to 2026: 7 510(k) clearances. Most are in product codes FJK (Set, Tubing, Blood, With And Without…) and FIE (Needle, Fistula). Its devices cite 7 predicates, 3 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 Bain Medical Equipment (Guangzhou) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
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