FDA applicant

Medwave, Inc.

St. Paul, MN5 decisions1995–20060 recalls

FDA records 5 decisions for Medwave, Inc. (St. Paul, MN) from 1995 to 2006: 5 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 2 predicates, 2 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

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

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

FDA decisions per year

No FDA decision for Medwave, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medwave, 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

Medwave, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?