IFUs and 510Ks

At Genesee BioMedical, we are committed to providing surgeons and regulatory teams with transparent product documentation. This page includes links to our Instructions for Use (IFUs) and FDA 510(k) clearance summaries, ensuring safe application, clinical confidence, and compliance for all of our cardiac surgery devices 

510Ks

Annuloplasty

Graft Markers

Other

Additional Resources