Draeger Medical Systems, Inc. is one of 16052 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Draeger Medical Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Infinity® Acute Care System (IACS) – VG8.1, Babyroo TN300, Infinity CentralStation Wide
49
Total
49
Cleared
0
Denied
Draeger Medical Systems, Inc. has 49 FDA 510(k) cleared cardiovascular devices. Based in Danvers, US.
Latest FDA clearance: Aug 2026. Active since 2003.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Draeger Medical Systems, Ind. as regulatory consultant.
FDA 510(k) Regulatory Record - Draeger Medical Systems, Inc.
49 devices
Cleared
Aug 20, 2026
Infinity® Acute Care System (IACS) – VG8.1
Cardiovascular
181d
Cleared
Jan 17, 2025
Babyroo TN300
General Hospital
57d
Cleared
Aug 01, 2024
Infinity CentralStation Wide
Cardiovascular
181d
Cleared
Jul 12, 2024
Infinity Gateway Suite
Cardiovascular
221d
Cleared
Oct 17, 2023
Infinity CentralStation Wide, Infinity M300, Infinity M300+
Cardiovascular
148d
Cleared
May 30, 2023
Babyroo TN300
General Hospital
118d
Cleared
Jun 07, 2022
Infinity Gateway Suite
Cardiovascular
547d
Cleared
Feb 01, 2022
Infinity Acute Care System (IACS) Monitoring System
Cardiovascular
476d
Cleared
Dec 09, 2021
Infinity Acute Care System (IACS) Monitoring Solution
Cardiovascular
528d
Cleared
Aug 28, 2020
Infinity M300
Cardiovascular
149d
Cleared
Nov 21, 2018
Isolette 8000 Plus
General Hospital
26d
Cleared
May 01, 2018
BiliLux
General Hospital
238d
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