FDA applicant
Foshan Coxo Medical Instrument Co., Ltd.
FDA records 7 decisions for Foshan Coxo Medical Instrument Co., Ltd. (Foshan, CN) from 2022 to 2025: 7 510(k) clearances. Most are in product codes EBZ (Activator, Ultraviolet, For Polymerization) and LQY (Locator, Root Apex). Since 2016 its 510(k)s took a median of 255 days from receipt to decision, against 155 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 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 Foshan Coxo Medical Instrument 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 2022.
Planning a device like Foshan Coxo Medical Instrument 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