FDA applicant

Ventana, Inc.

Tucson, AZ1 decision1999–19992 recalls

FDA records 1 decision for Ventana, Inc. (Tucson, AZ) in 1999: 1 510(k) clearance. All are in product code MYA (Immunohistochemistry Antibody Assay, Estrogen…). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Ventana, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ventana, Inc. since 2007.

Recalls per year

2in 2011

2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ventana, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Ventana”

FDA records each applicant name separately; these may or may not be the same firm.

Ventana Medical Systems, Inc. 62 Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) 3 Ventana Medical Sytems, Inc. 1

Ventana, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Ventana”