510(k) Report

FDA applicant

Medasense Biometrics, Ltd.

Ramat Gan, IL1 decision2023–20230 recalls

FDA records 1 decision for Medasense Biometrics, Ltd. (Ramat Gan, IL) in 2023: 1 De Novo grant. All are in product code QVE (Adjunctive Pain Measurement Device For…). 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Medasense Biometrics, Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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