FDA applicant
Beijing Sea Heart International Science and Technologyco.Ltd
FDA records 2 decisions for Beijing Sea Heart International Science and Technologyco.Ltd (Beijing, CN) from 2024 to 2026: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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 Beijing Sea Heart International Science and Technologyco.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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