Genesee Biomedical, Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)510(k)May 22, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 22, 2026
TransForm McCarthy Mitral Annuloplasty Ring (TF)510(k)Jul 25, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 25, 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)510(k)Apr 9, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 9, 2024
WellsForm Tricuspid Annuloplasty Band (WF)510(k)May 26, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 26, 2023