FDA applicant
Shenzhen Med-Link Electronics Tech Co., Ltd.
FDA records 14 decisions for Shenzhen Med-Link Electronics Tech Co., Ltd. (Shenzhen, CN) from 2009 to 2026: 14 510(k) clearances. Most are in product codes DQA (Oximeter) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 266 days from receipt to decision, against 198 for FDA’s reviews in the same codes and years. Its devices cite 18 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 Shenzhen Med-Link Electronics Tech 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 2009.
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