510(k) Report

FDA applicant

Ore-Medix, LLC

Midvale, UT1 decision2008–20080 recalls

FDA records 1 decision for Ore-Medix, LLC (Midvale, UT) in 2008: 1 510(k) clearance. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 2 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

How often FDA has decided Ore-Medix, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Ore-Medix, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K080648Traumastat Rapid Hemostatic Wound Dressing BandageOre-Medix, LLC · 2008

The one decision as Ore-Medix, LLC →