Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of RocheLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record. See the Roche group view.
As of Nov 15, 2026, FDA's public records list Ventana Medical Systems with 47 510(k) clearances and 42 device recalls. The most recent is a device recall dated Apr 20, 2026: navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital P….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 20, 2026 | navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 Class II · Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window | Device recalls |
| Dec 17, 2024 | Roche Digital Pathology DxK242783 · PSY | 510(k) clearances |
| Dec 5, 2024 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)DEN240025 · SDP | 510(k) clearances |
| Jun 27, 2024 | Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVDClass II · Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can re | Device recalls |
| Jun 14, 2024 | Roche Digital Pathology Dx (VENTANA DP 200)K232879 · PSY | 510(k) clearances |
| Nov 18, 2022 | VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 080085Class II · Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive ve | Device recalls |
| Dec 10, 2021 | CINtec HistologyK212176 · PRB | 510(k) clearances |
| May 8, 2018 | VENTANA CD30 (Ber-H2) RxDx AssayK172471 · DEH | 510(k) clearances |
| Mar 4, 2017 | CINtec Histology (50 tests), CINtec Histology (250 tests)DEN160019 · PRB | 510(k) clearances |
| Jul 16, 2015 | Virtuoso System for IHC PR (1E2) using iScan HTK142965 · OEO | 510(k) clearances |
| Mar 20, 2014 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINERK140465 · NQN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
