FDA applicant
Traferox Technologies, Inc.
FDA records 5 decisions for Traferox Technologies, Inc. (Mississauga, CA) from 2024 to 2026: 4 510(k) clearances and 1 original PMA approval. Most are in product codes KDN (System, Perfusion, Kidney) and MSB (System And Accessories, Isolated Heart…). Its devices cite 5 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 Traferox Technologies, Inc.’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.
Planning a device like Traferox Technologies, Inc.’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