FDA applicant
Ventana Medical Systems, Inc.
FDA records 62 decisions for Ventana Medical Systems, Inc. (Tucson, AZ) from 1992 to 2024: 46 510(k) clearances, 3 De Novo grants and 13 original PMA approvals. Most are in product codes DEH (Lambda, Antigen, Antiserum, Control) and NQN (Microscope, Automated, Image Analysis…). Its devices cite 19 predicates, 9 of them its own earlier devices. 7 recalls are linked to its devices, 2 Class I.
FDA’s records also spell it “Ventana Medical Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ventana Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2024
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Ventana Medical Systems, 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) ReportOther applicant names beginning “Ventana”
FDA records each applicant name separately; these may or may not be the same firm.