510(k) Report

FDA applicant

Angiomedics, Inc.

Minneapolis, MN8 decisions1984–19870 recalls

FDA records 8 decisions for Angiomedics, Inc. (Minneapolis, MN) from 1984 to 1987: 8 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and DYB (Introducer, Catheter). 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 Angiomedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Angiomedics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Angiomedics, 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