K150345

Substantially Equivalent

Magic3 Go Intermittent Urinary Catheter

Applicant: C.R. Bard, Inc.
Product code: EZD
Advisory panel: Gastroenterology, Urology
Date received: 2015-02-11
Decision date: 2015-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.