510(k) Report

FDA applicant

University of Utah Hospitals and Clinics

Salt Lake City, UT2 decisions2003–20080 recalls

FDA records 2 decisions for University of Utah Hospitals and Clinics (Salt Lake City, UT) from 2003 to 2008: 2 510(k) clearances. All are in product code JOW (Sleeve, Limb, Compressible). Its devices cite 4 predicates, 1 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 University of Utah Hospitals and Clinics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “University”

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