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Draeger Medical, Inc.

81 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an a recall (Z-0667-2025)Draeger Medical, Inc.2024-12-18
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an recall (Z-0668-2025)Draeger Medical, Inc.2024-12-18
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: recall (Z-0304-2025)Draeger Medical, Inc.2024-11-13
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Versio recall (Z-0305-2025)Draeger Medical, Inc.2024-11-13
Drger Perseus A500 Anesthesia Workstation recall (Z-1512-2024)Draeger Medical, Inc.2024-04-18
Carina Sub-Acute Care Ventilator recall (Z-2248-2023)Draeger Medical, Inc.2023-08-18
Oxylog 3000 Plus emergency and transport ventilator recall (Z-2018-2023)Draeger Medical, Inc.2023-07-08
Seattle PAP Plus, MP02260 recall (Z-1439-2023)Draeger Medical, Inc.2023-05-17
VentStar Basic (P)180, MP00351 recall (Z-1440-2023)Draeger Medical, Inc.2023-05-17
VentStar Basic (P)250, MP00352 recall (Z-1441-2023)Draeger Medical, Inc.2023-05-17
VentStar Watertrap (P) 180, MP00361 recall (Z-1442-2023)Draeger Medical, Inc.2023-05-17
VentStar Watertrap (P) 180 w/oLL, MP00362 recall (Z-1443-2023)Draeger Medical, Inc.2023-05-17
VentStar Anesthesia WT (P)180, MP00374 recall (Z-1444-2023)Draeger Medical, Inc.2023-05-17
VentStar breathing bag Set (P) 110, MP00384 recall (Z-1445-2023)Draeger Medical, Inc.2023-05-17
ID Circuit Basic (P) 180, MP01340 recall (Z-1446-2023)Draeger Medical, Inc.2023-05-17
VentStar Anesthesia (N) 180, MP00333 recall (Z-1447-2023)Draeger Medical, Inc.2023-05-17
VentStar Basic (N) 180, MP00353 recall (Z-1448-2023)Draeger Medical, Inc.2023-05-17
VentStar Watertrap (N) 180, MP00363 recall (Z-1449-2023)Draeger Medical, Inc.2023-05-17
VentStar Bag Set (N) 110, MP00383 recall (Z-1450-2023)Draeger Medical, Inc.2023-05-17
VentStar Coax (P) 150, MP00379 recall (Z-1451-2023)Draeger Medical, Inc.2023-05-17
Anesthesia Circuit Kit Coax 1, MP02730 recall (Z-1452-2023)Draeger Medical, Inc.2023-05-17
Anesthesia Circuit Kit Coax 3, MP02732 recall (Z-1453-2023)Draeger Medical, Inc.2023-05-17
Ventstar Coax, MP03373 recall (Z-1454-2023)Draeger Medical, Inc.2023-05-17
Ventstar Coax 180, MP03374 recall (Z-1455-2023)Draeger Medical, Inc.2023-05-17
ID Coax 180, MP03375 recall (Z-1456-2023)Draeger Medical, Inc.2023-05-17
Ventstar Coax 230, MP03376 recall (Z-1457-2023)Draeger Medical, Inc.2023-05-17
Anesthesia Set Coax 180, MP03384 recall (Z-1458-2023)Draeger Medical, Inc.2023-05-17
Set2Go Ventilation 12 (A), MP07968 recall (Z-1459-2023)Draeger Medical, Inc.2023-05-17
Anesthesia Circuit Kit Coax HEPA, MP17102 recall (Z-1460-2023)Draeger Medical, Inc.2023-05-17
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Si recall (Z-1137-2023)Draeger Medical, Inc.2023-02-24
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M) recall (Z-1138-2023)Draeger Medical, Inc.2023-02-24
VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Wa recall (Z-0736-2019)Draeger Medical, Inc.2019-01-24
VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Wa recall (Z-0737-2019)Draeger Medical, Inc.2019-01-24
VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without recall (Z-0738-2019)Draeger Medical, Inc.2019-01-24
VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without recall (Z-0739-2019)Draeger Medical, Inc.2019-01-24
VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets with recall (Z-0740-2019)Draeger Medical, Inc.2019-01-24
VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/Anesthesia Sets w recall (Z-0741-2019)Draeger Medical, Inc.2019-01-24
ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/Anesthesia Sets wi recall (Z-0742-2019)Draeger Medical, Inc.2019-01-24
ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesia Sets without a recall (Z-0743-2019)Draeger Medical, Inc.2019-01-24
ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesia Sets without a recall (Z-0744-2019)Draeger Medical, Inc.2019-01-24
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhala recall (Z-1481-2018)Draeger Medical, Inc.2018-05-08
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are recall (Z-1482-2018)Draeger Medical, Inc.2018-05-08
Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhal recall (Z-1483-2018)Draeger Medical, Inc.2018-05-08
Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inh recall (Z-1484-2018)Draeger Medical, Inc.2018-05-08
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Ox recall (Z-2215-2016)Draeger Medical, Inc.2016-08-04
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. recall (Z-0827-2016)Draeger Medical, Inc.2016-02-25
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume recall (Z-0691-2016)Draeger Medical, Inc.2016-02-03
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Cata recall (Z-0692-2016)Draeger Medical, Inc.2016-02-03
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilato recall (Z-0436-2016)Draeger Medical, Inc.2015-12-23
Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, ch recall (Z-0360-2016)Draeger Medical, Inc.2015-12-12
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventila recall (Z-2343-2015)Draeger Medical, Inc.2015-08-14
Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in M recall (Z-2271-2015)Draeger Medical, Inc.2015-07-27
Reusable latex breathing bags with multiple part numbers and sold as part of test lung par recall (Z-1452-2014)Draeger Medical, Inc.2014-04-10
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating thea recall (Z-0282-2014)Draeger Medical, Inc.2013-11-14
Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to recall (Z-0008-2014)Draeger Medical, Inc.2013-10-10
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Inf recall (Z-0939-2013)Draeger Medical, Inc.2013-03-11
Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, phy recall (Z-0281-2012)Draeger Medical, Inc.2011-11-23
Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Mo recall (Z-0263-2012)Draeger Medical, Inc.2011-11-22
Delta/Delta XL Monitors with Omega S Package recall (Z-0582-2010)Draeger Medical, Inc.2009-12-29
Drager Surgical Lights Sola 500 and Sola 700. recall (Z-2212-2009)Draeger Medical, Inc.2009-09-16
Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home recall (Z-1263-2009)Draeger Medical, Inc.2009-05-14
Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version recall (Z-0202-2009)Draeger Medical, Inc.2008-10-27
Draeger Medical Apollo Anesthesia Machine, catalog number 8606500 recall (Z-0087-2009)Draeger Medical, Inc.2008-10-08
Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is u recall (Z-2338-2008)Draeger Medical, Inc.2008-09-23
Evita 2 dura Critical Care Ventilator. Continuous (Respirator) recall (Z-2325-2008)Draeger Medical, Inc.2008-09-20
Evita 4 Critical Care Ventilator. Continuous (Respirator) recall (Z-2326-2008)Draeger Medical, Inc.2008-09-20
Evita XL Critical Care Ventilator. Continuous (Respirator) recall (Z-2327-2008)Draeger Medical, Inc.2008-09-20
Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 860 recall (Z-1315-2008)Draeger Medical, Inc.2008-07-16
Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., recall (Z-1051-2008)Draeger Medical, Inc.2008-03-18
Draeger GT500. GlobeTrotter Transport System. Catalog Number: MU20508, Draeger Medical, In recall (Z-1052-2008)Draeger Medical, Inc.2008-03-18
Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 1896 recall (Z-1053-2008)Draeger Medical, Inc.2008-03-18
Medical Air Compressor Model #8413419 recall (Z-0674-2007)Draeger Medical, Inc.2007-04-05
Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715 recall (Z-0301-2007)Draeger Medical, Inc.2006-12-19
Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. recall (Z-0302-2007)Draeger Medical, Inc.2006-12-19
Infinity Docking Station (IDS) (transportable patient monitor) Repair Kit, part number 726 recall (Z-0303-2007)Draeger Medical, Inc.2006-12-19
Fabius GS Anesthesia Machine. Catalog number 8604699 recall (Z-0048-2007)Draeger Medical, Inc.2006-10-19
Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator recall (Z-0515-06)Draeger Medical, Inc.2006-02-14
APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 411 recall (Z-0192-05)Draeger Medical, Inc.2004-11-11
Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp recall (Z-0358-04)Draeger Medical, Inc.2004-01-22
Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp recall (Z-0359-04)Draeger Medical, Inc.2004-01-22
Evita 4 Continuous Ventilator recall (Z-0954-03)Draeger Medical, Inc.2003-06-27

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