510(k) K142818— Phasix Mesh

Substantially Equivalent

C. R. Bard

Clearance details

Applicant: C. R. Bard
Product code: Code OOD
Advisory panel: General, Plastic Surgery
Date received: 2014-09-29
Decision date: 2015-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warwick, RI, US

Adverse events under product code OOD

product code OOD

Death: 6
Injury: 1,005
Total: 1,011

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.