FDA applicant
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
FDA records 2 decisions for Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) (Charlotte, NC) from 2025 to 2026: 2 510(k) clearances. All are in product code FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 3 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 Q3 Medical USA, LLC (C/O Q3 Medical Devices 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 2025.
Planning a device like Q3 Medical USA, LLC (C/O Q3 Medical…’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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