Livanova Deutschland, GmbH FDA Approvals

0 new drug approvals and 6 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
Essenz HLM, Essenz ILBM510(k)Aug 24, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Aug 24, 2023
Essenz HLM510(k)Mar 9, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 9, 2023
Heater-Cooler System 3T510(k)Nov 16, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 16, 2022
ESSENZ Patient Monitor510(k)Nov 10, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Nov 10, 2021
Stockert S5 System510(k)Apr 5, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 5, 2021
B-Capta510(k)Apr 1, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 1, 2021