Draeger Medical Systems, Inc. FDA Approvals

0 new drug approvals and 9 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
Infinity® Acute Care System (IACS) VG8.1510(k)Aug 20, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 20, 2026
Babyroo TN300510(k)Jan 17, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 17, 2025
Infinity CentralStation Wide510(k)Aug 1, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 1, 2024
Infinity Gateway Suite510(k)Jul 12, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 12, 2024
Infinity CentralStation Wide, Infinity M300, Infinity M300+510(k)Oct 17, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 17, 2023
Babyroo TN300510(k)May 30, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 30, 2023
Infinity Gateway Suite510(k)Jun 7, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 7, 2022
Infinity Acute Care System (IACS) Monitoring System510(k)Feb 1, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 1, 2022
Infinity Acute Care System (IACS) Monitoring Solution510(k)Dec 9, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 9, 2021