FDA applicant

Landauer

Glenwood, IL1 decision2019–201939 recalls

FDA records 1 decision for Landauer (Glenwood, IL) in 2019: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 1 predicate, 0 of them its own earlier devices. 39 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, radiology panel, where it files most

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

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

39in 2023

2019high 39 (2023) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Landauer by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Landauer’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

Landauer

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?