FDA applicant
Solaplus Biotech Co., Ltd.
FDA records 1 decision for Solaplus Biotech Co., Ltd. (Wenzhou, CN) in 2020: 1 510(k) clearance. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). 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 Solaplus Biotech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Solaplus Biotech 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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