FDA applicant
Changzhou Sifary Medical Technology Co., Ltd.
FDA records 5 decisions for Changzhou Sifary Medical Technology Co., Ltd. (Changzhou, CN) from 2021 to 2026: 5 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and EKX (Handpiece, Direct Drive, Ac-Powered). Since 2016 its 510(k)s took a median of 192 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Changzhou Sifary Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
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