BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH— 510(k) K061314

Substantially Equivalent

Davol Inc., Sub. C. R. Bard, Inc.

FDA 510(k) clearance K061314 for BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH, Substantially Equivalent on 2006-06-02. Applicant: Davol Inc., Sub. C. R. Bard, Inc..

Clearance details

Applicant: Davol Inc., Sub. C. R. Bard, Inc.
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2006-05-11
Decision date: 2006-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canston, RI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.