FDA applicant
Medwaves Incorporated
FDA records 4 decisions for Medwaves Incorporated (San Diego, CA) from 2007 to 2020: 4 510(k) clearances. All are in product code NEY (System, Ablation, Microwave And Accessories). Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Medwaves, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medwaves Incorporated’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medwaves Incorporated’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