510(k) Report

FDA applicant

Laminate Medical Technologies, Ltd.

Tel Aviv, IL2 decisions2023–20240 recalls

FDA records 2 decisions for Laminate Medical Technologies, Ltd. (Tel Aviv, IL) from 2023 to 2024: 1 510(k) clearance and 1 De Novo grant. All are in product code QVQ (Extravascular Support For An Arteriovenous…). Its devices cite 1 predicate, 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, cardiovascular panel, where it files most

How often FDA has decided Laminate Medical Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

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

Planning a device like Laminate Medical Technologies, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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