FDA applicant
Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
FDA records 7 decisions for Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (Beijing, CN) from 2020 to 2024: 7 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GDW (Staple, Implantable). Since 2016 its 510(k)s took a median of 147 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 8 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 Beijing Biosis Healing Biolog Ical Technology 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 2020.
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