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Draeger Medical Systems, Inc.

20 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is inten recall (Z-1066-2025)Draeger Medical Systems, Inc.2025-01-30
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. M recall (Z-2189-2024)Draeger Medical Systems, Inc.2024-06-25
Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, recall (Z-1992-2023)Draeger Medical Systems, Inc.2023-06-22
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neon recall (Z-1471-2023)Draeger Medical Systems, Inc.2023-04-27
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on recall (Z-1472-2023)Draeger Medical Systems, Inc.2023-04-27
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doct recall (Z-2046-2018)Draeger Medical Systems, Inc.2018-06-07
Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doct recall (Z-2047-2018)Draeger Medical Systems, Inc.2018-06-07
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 570 recall (Z-1440-2014)Draeger Medical Systems, Inc.2014-04-10
Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infin recall (Z-1298-2014)Draeger Medical Systems, Inc.2014-03-28
Draeger Infinity Acute Care System Monitoring Solution recall (Z-0714-2014)Draeger Medical Systems, Inc.2014-01-10
Drager PT 4000 Phototherapy System recall (Z-1950-2012)Draeger Medical Systems, Inc.2012-07-06
Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor us recall (Z-3047-2011)Draeger Medical Systems, Inc.2011-08-22
Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monit recall (Z-3048-2011)Draeger Medical Systems, Inc.2011-08-22
Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 31 recall (Z-0018-2011)Draeger Medical Systems, Inc.2010-10-07
Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telf recall (Z-2478-2010)Draeger Medical Systems, Inc.2010-09-23
Fabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Te recall (Z-2479-2010)Draeger Medical Systems, Inc.2010-09-23
Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of recall (Z-2283-2010)Draeger Medical Systems, Inc.2010-08-26
Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of recall (Z-2284-2010)Draeger Medical Systems, Inc.2010-08-26
Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR8 recall (Z-1693-2009)Draeger Medical Systems, Inc.2009-08-26
Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3 recall (Z-1955-2009)Draeger Medical Systems, Inc.2009-08-25

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Every clearance here is in the API, with alerts when new ones post.