FDA applicant
Gwowei Technology Co., Ltd.
FDA records 2 decisions for Gwowei Technology Co., Ltd. (Flagstaff, AZ) in 2008: 2 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). Its devices cite 2 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 Gwowei Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2008
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Gwowei Technology Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report