FDA applicant
Shanghai Handy Medical Equipment Co., Ltd.
FDA records 1 decision for Shanghai Handy Medical Equipment Co., Ltd. (Baoshan District, CN) in 2022: 1 510(k) clearance. All are in product code MUH (System, X-Ray, Extraoral Source, Digital). 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 Shanghai Handy Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2022high 1 (2022) · low 0 (2023)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Shanghai Handy 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