510(k) Report

FDA applicant

Ultrazonix Dnt AB

Minneapolis, MN1 decision2006–20060 recalls

FDA records 1 decision for Ultrazonix Dnt AB (Minneapolis, MN) in 2006: 1 510(k) clearance. All are in product code NTB (System, Ablation, Ultrasound And Accessories). Its devices cite 3 predicates, 0 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, general and plastic surgery panel, where it files most

How often FDA has decided Ultrazonix Dnt AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ultrazonix Dnt AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ultrazonix Dnt AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NTBSystem, Ablation, Ultrasound And Accessories1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB · 2006

The one decision as Ultrazonix Dnt AB →