FDA applicant
Canwell Medical Co., Ltd.
FDA records 3 decisions for Canwell Medical Co., Ltd. (Jinhua, CN) from 2015 to 2025: 3 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). Its devices cite 13 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 Canwell Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Canwell Medical 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