Soundbite Medical Solutions, Inc. FDA Approvals

0 new drug approvals and 2 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
SoundBite® Crossing System XS Peripheral510(k)Aug 28, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 28, 2023
SoundBite Crossing System - Peripheral (14P)510(k)Apr 20, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 20, 2021