510(k) Report

FDA applicant

Asia-Med GmbH & Co. Kg. - Werk Suhl

Littleton, CO1 decision2004–20040 recalls

FDA records 1 decision for Asia-Med GmbH & Co. Kg. - Werk Suhl (Littleton, CO) in 2004: 1 510(k) clearance. All are in product code MQX (Needle, Acupuncture, Single Use). 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 hospital panel, where it files most

How often FDA has decided Asia-Med GmbH & Co. Kg. - Werk Suhl’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Asia-Med GmbH & Co. Kg. - Werk Suhl since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Asia-Med GmbH & Co. Kg. - Werk Suhl 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?

  • MQXNeedle, Acupuncture, Single Use1decision

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.

  • K042063Press Tack NeedleAsia-Med GmbH & Co. Kg. - Werk Suhl · 20041cites it

What has FDA decided for it lately?

  • K042063Press Tack NeedleAsia-Med GmbH & Co. Kg. - Werk Suhl · 2004

The one decision as Asia-Med GmbH & Co. Kg. - Werk Suhl →