510(k) Report

FDA applicant

Av Medical Technologies, Ltd.

Tel-Aviv, IL3 decisions2015–20172 recalls

FDA records 3 decisions for Av Medical Technologies, Ltd. (Tel-Aviv, IL) from 2015 to 2017: 3 510(k) clearances. All are in product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). Its devices cite 4 predicates, 2 of them its own earlier devices. 2 recalls are 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 Av Medical Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2015: 12017: 2
2015high 2 (2017) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2024

2021: 12024: 1
2015high 1 (2021) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Av Medical Technologies, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Av 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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