AliveCor, Inc. FDA Approvals

0 new drug approvals and 7 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
Corvair Monza510(k)Jan 9, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 9, 2026
Impala510(k)Jun 7, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 7, 2024
Corvair510(k)Jun 7, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 7, 2024
KardiaMobile 6L510(k)May 25, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 25, 2022
AliveCor QT Service510(k)Apr 26, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 26, 2022
KardiaMobile Card510(k)Nov 30, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Nov 30, 2021
KardiaMobile 6L510(k)Jun 30, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 30, 2021