Bioventus, LLC FDA Approvals

0 new drug approvals and 5 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
StimTrial Neuromodulation System510(k)Aug 26, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	Aug 26, 2026
StimTrial Neuromodulation System510(k)Jul 16, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 16, 2025
TalisMann Neuromodulation System510(k)Jul 3, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 3, 2025
Allograft Delivery Device (OFAC-C)510(k)Jun 25, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jun 25, 2024
SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty510(k)Dec 5, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 5, 2023