XENMATRIX SURGICAL GRAFT— 510(k) K140501

Substantially Equivalent

C. R. Bard

FDA 510(k) clearance K140501 for XENMATRIX SURGICAL GRAFT, Substantially Equivalent on 2014-04-28. Applicant: C. R. Bard.

Clearance details

Applicant: C. R. Bard
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2014-02-27
Decision date: 2014-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Warwick, RI, US

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Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.