FDA applicant
Enlight Medical Technologies (Shenzhen) Co., Ltd.
FDA records 1 decision for Enlight Medical Technologies (Shenzhen) Co., Ltd. (Shenzhen, CN) in 2024: 1 510(k) clearance. All are in product code MOF (Guide, Wire, Catheter, Neurovasculature). 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 Enlight Medical Technologies (Shenzhen) Co., Ltd.’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.
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