FDA applicant

Meditron AS

Chapel Hill, NC4 decisions1993–20060 recalls

FDA records 4 decisions for Meditron AS (Chapel Hill, NC) from 1993 to 2006: 4 510(k) clearances. Most are in product codes DQD (Stethoscope, Electronic) and NYK (Ophthalmodynamometer, Diagnostic Contact Lens…). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Meditron, GmbH”, “Meditron Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Meditron AS’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Meditron AS since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Meditron AS’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Meditron”

FDA records each applicant name separately; these may or may not be the same firm.

Meditron Devices, Inc. 2

Meditron AS

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Meditron”