FDA applicant
Guangzhou Ajax Medical Equipment Co., Ltd.
FDA records 3 decisions for Guangzhou Ajax Medical Equipment Co., Ltd. (Guangzhou, CN) from 2021 to 2026: 3 510(k) clearances. Most are in product codes FLE (Sterilizer, Steam) and EHD (Unit, X-Ray, Extraoral With Timer). Since 2016 its 510(k)s took a median of 248 days from receipt to decision, against 184 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Guangzhou Ajax Medical Equipment 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 2021.
Planning a device like Guangzhou Ajax Medical Equipment Co.…’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