FDA applicant
Shandong Ande Healthcare Apparatus Co., Ltd.
FDA records 1 decision for Shandong Ande Healthcare Apparatus Co., Ltd. (Shandong, CN) in 2024: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). Its devices cite 1 predicate, 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 Shandong Ande Healthcare Apparatus 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 2024.
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