MIROMATRIX BIOLOGICAL MESH— 510(k) K134033

Substantially Equivalent

Miromatrix Medical, Inc.

FDA 510(k) clearance K134033 for MIROMATRIX BIOLOGICAL MESH, Substantially Equivalent on 2014-03-31. Applicant: Miromatrix Medical, Inc..

Clearance details

Applicant: Miromatrix Medical, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2013-12-31
Decision date: 2014-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

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.