FDA applicant

University of Michigan

Ann Arbor, MI2 decisions1990–19970 recalls

FDA records 2 decisions for University of Michigan (Ann Arbor, MI) from 1990 to 1997: 2 510(k) clearances. Most are in product codes IWJ (System, Applicator, Radionuclide, Manual) and FPA (Set, Administration, Intravascular). 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, radiology panel, where it files most

How often FDA has decided University of Michigan’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for University of Michigan since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like University of Michigan’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 “University”

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

University of Texas Medical School AT Houston 2 The University of Chicago 2 University of Utah Hospitals and Clinics 2 University of Washington 2 University of Utah, Department of Orthopaedics 2 University of Utah/School of Medicine 1 University of Texas, MD Anderson Cancer Center 1 University of Wisconsin 1 University of Otago 1 University of Florida 1 University Hospital (London) Development Corp. 1 University of Texas Medical School AT Houston, Texas 1

University of Michigan

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “University”