510(k) Report

FDA applicant

Medtronic Navigation Israel, Ltd.

Yokneam Elit, IL1 decision2010–20101 recall

FDA records 1 decision for Medtronic Navigation Israel, Ltd. (Yokneam Elit, IL) in 2010: 1 510(k) clearance. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, radiology panel, where it files most

How often FDA has decided Medtronic Navigation Israel, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2010high 1 (2016) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Navigation Israel, Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K092308Polestar, Model N-30Medtronic Navigation Israel, Ltd. · 20101 recall

The one decision as Medtronic Navigation Israel, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K092308PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables…Jun 20, 2016Class II