FDA applicant

Nuvo- Group, Ltd.

Tel Aviv, IL3 decisions2020–20220 recalls

FDA records 3 decisions for Nuvo- Group, Ltd. (Tel Aviv, IL) from 2020 to 2022: 3 510(k) clearances. All are in product code LQK (Home Uterine Activity Monitor). Its devices cite 3 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Nuvo- Group, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020high 1 (2020) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Nuvo- Group, Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nuvo- Group, 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 “Nuvo-”

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

Nuvo, Inc. 1

Nuvo- Group, Ltd.

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 “Nuvo-”