FDA applicant
Biogend Therapeutics Co., Ltd.
FDA records 1 decision for Biogend Therapeutics Co., Ltd. (Taipei, TW) in 2024: 1 510(k) clearance. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). 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 Biogend Therapeutics 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.
Planning a device like Biogend Therapeutics Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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