FDA applicant
Vales & Hills Biomedical Tech., Ltd.
FDA records 2 decisions for Vales & Hills Biomedical Tech., Ltd. (Beijing, CN) from 2013 to 2017: 2 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and MLO (Electrocardiograph, Ambulatory, With Analysis…). Its devices cite 2 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 Vales & Hills Biomedical Tech., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Vales & Hills Biomedical Tech., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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