FDA applicant
Telefield Medical Imaging (Shenzhen) Limited
FDA records 1 decision for Telefield Medical Imaging (Shenzhen) Limited (Shenzhen, CN) in 2024: 1 510(k) clearance. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 1 predicate, 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 Telefield Medical Imaging (Shenzhen) Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Telefield Medical Imaging (Shenzhen)…’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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