510(k) Report

FDA applicant

Euroresearch Srl

Crofton, MD1 decision2005–20050 recalls

FDA records 1 decision for Euroresearch Srl (Crofton, MD) in 2005: 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 Euroresearch Srl’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Euroresearch Srl since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Euroresearch Srl’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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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:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040283BiopadEuroresearch Srl · 20052cite it

What has FDA decided for it lately?

  • K040283BiopadEuroresearch Srl · 2005

The one decision as Euroresearch Srl →