FDA applicant

Lazarus Medical, Inc.

Salt Lake City, UT2 decisions1991–20080 recalls

FDA records 2 decisions for Lazarus Medical, Inc. (Salt Lake City, UT) from 1991 to 2008: 2 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and BTO (Tube, Tracheostomy (W/Wo Connector)). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Lazarus Medical, LLC”.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lazarus Medical, 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) Report

Other applicant names beginning “Lazarus”

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

Lazarus 3D 2 Lazarus Effect, Inc. 1 Lazarus Medical Innovations, Inc. 1

Lazarus Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Lazarus”