Abbott FDA Approvals

0 new drug approvals and 8 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
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter510(k)Jul 2, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 2, 2026
Amplatzer TorqVue Delivery System510(k)Apr 24, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 24, 2026
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)510(k)Sep 17, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 17, 2025
Lingo Glucose System510(k)May 29, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 29, 2024
CentriMag Pre-connected Pack510(k)Dec 1, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 1, 2022
EnSite X EP System510(k)Aug 18, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 18, 2022
EnSite X EP System510(k)Oct 22, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 22, 2021
WorkMate Claris System510(k)Mar 11, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Mar 11, 2021