FDA applicant

Meridian Bioscience Israel, Ltd.

Modiin, IL3 decisions2022–20220 recalls

FDA records 3 decisions for Meridian Bioscience Israel, Ltd. (Modiin, IL) in 2022: 3 510(k) clearances. All are in product code MSQ (Test, Urea (Breath Or Blood)). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 121 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

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

How often FDA has decided Meridian Bioscience Israel, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2022high 3 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Meridian Bioscience Israel, Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Meridian Bioscience Israel, Ltd.’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 “Meridian”

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

Meridian Diagnostics, Inc. 92 Meridian Bioscience, Inc. 39 Meridian AG 14 Meridian Medical Systems, LLC 8 Meridian Medical Technologies, Inc. 6 Meridian Technique, Ltd. 1 Meridian Dynamics Biomedical, Inc. 1 Meridian Medical 1

Meridian Bioscience Israel, Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Meridian”