FDA applicant

Exalenz Bioscience, Ltd.

Modiin, IL5 decisions2013–20200 recalls

FDA records 5 decisions for Exalenz Bioscience, Ltd. (Modiin, IL) from 2013 to 2020: 5 510(k) clearances. All are in product code MSQ (Test, Urea (Breath Or Blood)). Its devices cite 5 predicates, 4 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 Exalenz Bioscience, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2013high 2 (2018) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Exalenz Bioscience, Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Exalenz Bioscience, Ltd.

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?