510(k) Report

FDA applicant

Intl. Medical-Dental Products USA, Inc.

Park City, UT1 decision1993–19930 recalls

FDA records 1 decision for Intl. Medical-Dental Products USA, Inc. (Park City, UT) in 1993: 1 510(k) clearance. All are in product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). 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, anesthesiology panel, where it files most

How often FDA has decided Intl. Medical-Dental Products USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intl. Medical-Dental Products USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intl. Medical-Dental Products USA, Inc. 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?

  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K931644Gertie Marx NeedleIntl. Medical-Dental Products USA, Inc. · 19931cites it

What has FDA decided for it lately?

  • K931644Gertie Marx NeedleIntl. Medical-Dental Products USA, Inc. · 1993

The one decision as Intl. Medical-Dental Products USA, Inc. →