FDA applicant
Ushare Medical, Inc.
FDA records 2 decisions for Ushare Medical, Inc. (Zhuhai, CN) from 2020 to 2024: 2 510(k) clearances. Most are in product codes FCG (Biopsy Needle) and QSY (Hemostatic Wound Dressing Without Thrombin Or…). 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 Ushare Medical, Inc.’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.
Planning a device like Ushare Medical, Inc.’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