FDA applicant

Med Fusion Systems, Inc.

Mchenry, IL22 decisions1977–19871 recall

FDA records 22 decisions for Med Fusion Systems, Inc. (Mchenry, IL) from 1977 to 1987: 22 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and ITQ (Joint, Knee, External Brace). 1 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 Med Fusion Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med Fusion Systems, Inc. since 2007.

Recalls per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Med Fusion Systems, 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

Med Fusion Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?