FDA applicant
Gt Medical Technologies
FDA records 3 decisions for Gt Medical Technologies (Tempe, AZ) from 2019 to 2022: 3 510(k) clearances. All are in product code KXK (Source, Brachytherapy, Radionuclide). Its devices cite 3 predicates, 2 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 Gt Medical Technologies’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Gt Medical Technologies’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report