DeviceClearance

K143380

Substantially Equivalent

Phasix ST Mesh

Applicant
C.R. Bard, Inc.
Product code
OWT
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warwick, RI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OWT

product code OWT
Death
3
Injury
396
Total
399

Source: openFDA MAUDE database, through . 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.