Bardy Diagnostics, 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
Carnation Ambulatory Monitor510(k)Nov 22, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 22, 2023
Carnation Ambulatory Monitor (CAM)510(k)Feb 5, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Feb 5, 2021