FDA applicant

Lazarus 3D

Albany, OR2 decisions2021–20230 recalls

FDA records 2 decisions for Lazarus 3D (Albany, OR) from 2021 to 2023: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Lazarus 3D, Inc.”.

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 Lazarus 3D’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Lazarus 3D by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lazarus 3D’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

Other applicant names beginning “Lazarus”

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

Lazarus Medical, Inc. 2 Lazarus Effect, Inc. 1 Lazarus Medical Innovations, Inc. 1

Lazarus 3D

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Lazarus”