FDA applicant

Madaus Medtec, Inc.

Spring House, PA2 decisions1990–19900 recalls

FDA records 2 decisions for Madaus Medtec, Inc. (Spring House, PA) in 1990: 2 510(k) clearances. All are in product code BZQ (Monitor, Breathing Frequency). 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 Madaus Medtec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Madaus Medtec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Madaus Medtec, Inc.’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

Madaus Medtec, Inc.

Which product codes does it file in?

What has FDA decided for it lately?