FDA applicant
Cianna Medical, Inc.
FDA records 10 decisions for Cianna Medical, Inc. (Aliso Viejo, CA) from 2008 to 2018: 10 510(k) clearances. Most are in product codes JAQ (System, Applicator, Radionuclide…) and NEU (Marker, Radiographic, Implantable). Its devices cite 16 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Cianna Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cianna Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Cianna Medical, 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