FDA applicant
Gimbo Medical Technology Shenzhen Co., Ltd.
FDA records 7 decisions for Gimbo Medical Technology Shenzhen Co., Ltd. (Shenzhen, CN) from 2024 to 2026: 7 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQK (Labware, Assisted Reproduction). Since 2016 its 510(k)s took a median of 144 days from receipt to decision, against 195 for FDA’s reviews in the same codes and years. 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 Gimbo Medical Technology Shenzhen Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
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