Medical Device Manufacturer · US , Danvers , MA

Draeger Medical Systems, Inc. - FDA 510(k) Cleared Devices

48 submissions · 48 cleared · Since 2003
48
Total
48
Cleared
0
Denied

Draeger Medical Systems, Inc. has 48 FDA 510(k) cleared cardiovascular devices. Based in Danvers, US.

Latest FDA clearance: Jan 2025. 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.

48 devices
1–12 of 48
Babyroo TN300
K243606 · FMT Warmer, Infant Radiant · General Hospital
Jan 2025 57d
Infinity CentralStation Wide
K240312 · MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · Cardiovascular
Aug 2024 181d
Infinity Gateway Suite
K233834 · MSX System, Network And Communication, Physiological Monitors · Cardiovascular
Jul 2024 221d
Infinity CentralStation Wide, Infinity M300, Infinity M300+
K231477 · MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · Cardiovascular
Oct 2023 148d
Babyroo TN300
K230278 · FMT Warmer, Infant Radiant · General Hospital
May 2023 118d
Infinity Gateway Suite
K203579 · MSX System, Network And Communication, Physiological Monitors · Cardiovascular
Jun 2022 547d
Infinity Acute Care System (IACS) Monitoring System
K203088 · MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · Cardiovascular
Feb 2022 476d
Infinity Acute Care System (IACS) Monitoring Solution
K201764 · MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · Cardiovascular
Dec 2021 528d
Infinity M300
K200859 · MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · Cardiovascular
Aug 2020 149d
Isolette 8000 Plus
K182977 · FMZ Incubator, Neonatal · General Hospital
Nov 2018 26d
BiliLux
K172656 · LBI Unit, Neonatal Phototherapy · General Hospital
May 2018 238d
Infinity CentralStation Wide
K151860 · MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · Cardiovascular
Sep 2015 56d

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