FDA applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
FDA records 8 decisions for Shenzhen HugeMed Medical Technical Development Co., Ltd. (Shenzhen, CN) from 2023 to 2026: 8 510(k) clearances. Most are in product codes FBN (Choledochoscope And Accessories, Flexible/Rigid) and EOQ (Bronchoscope (Flexible Or Rigid)). Since 2016 its 510(k)s took a median of 160 days from receipt to decision, against 155 for FDA’s reviews in the same codes and years. Its devices cite 8 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 Shenzhen HugeMed Medical Technical Development Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
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