Draeger Medical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 78 (53 Class I)
- 510(k) Clearances
- 84
- Inspections
- 0
- Compliance Actions
- 0
Known Names
draeger medical systems, draeger medical, draeger medical ag and co. kgaa, draeger medical ag and co. kg
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0304-2025 | Class I | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not ap | October 15, 2024 |
| Z-0668-2025 | Class I | Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an a | October 15, 2024 |
| Z-0305-2025 | Class I | Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not | October 15, 2024 |
| Z-0667-2025 | Class I | Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an ane | October 15, 2024 |
| Z-1512-2024 | Class I | Dr¿ger Perseus A500 Anesthesia Workstation | March 20, 2024 |
| Z-2248-2023 | Class I | Carina Sub-Acute Care Ventilator | July 12, 2023 |
| Z-2018-2023 | Class I | Oxylog 3000 Plus emergency and transport ventilator | June 12, 2023 |
| Z-1456-2023 | Class I | ID Coax 180, MP03375 | April 17, 2023 |
| Z-1455-2023 | Class I | Ventstar Coax 180, MP03374 | April 17, 2023 |
| Z-1444-2023 | Class I | VentStar Anesthesia WT (P)180, MP00374 | April 17, 2023 |
| Z-1449-2023 | Class I | VentStar Watertrap (N) 180, MP00363 | April 17, 2023 |
| Z-1454-2023 | Class I | Ventstar Coax, MP03373 | April 17, 2023 |
| Z-1450-2023 | Class I | VentStar Bag Set (N) 110, MP00383 | April 17, 2023 |
| Z-1458-2023 | Class I | Anesthesia Set Coax 180, MP03384 | April 17, 2023 |
| Z-1460-2023 | Class I | Anesthesia Circuit Kit Coax HEPA, MP17102 | April 17, 2023 |
| Z-1453-2023 | Class I | Anesthesia Circuit Kit Coax 3, MP02732 | April 17, 2023 |
| Z-1441-2023 | Class I | VentStar Basic (P)250, MP00352 | April 17, 2023 |
| Z-1443-2023 | Class I | VentStar Watertrap (P) 180 w/oLL, MP00362 | April 17, 2023 |
| Z-1448-2023 | Class I | VentStar Basic (N) 180, MP00353 | April 17, 2023 |
| Z-1442-2023 | Class I | VentStar Watertrap (P) 180, MP00361 | April 17, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K121886 | SAVINA 300 SAVINA 300, COUNTRY VARIANTS | August 8, 2014 |
| K133886 | PERSEUS A500 | June 20, 2014 |
| K121999 | GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE | February 28, 2013 |
| K103035 | SMARTPILOT VIEW MODEL MK04500 | March 28, 2012 |
| K082600 | OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) | November 26, 2008 |
| K060705 | CARINA HOME | June 14, 2006 |
| K042607 | PRIMUS US | November 26, 2004 |
| K042419 | FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM | October 8, 2004 |
| K042276 | D-VAPOR | September 23, 2004 |
| K042086 | FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | August 31, 2004 |
| K041622 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | July 8, 2004 |
| K040847 | MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR | June 17, 2004 |
| K033498 | NARKOMED 6400, MODEL NM6400 | April 26, 2004 |
| K030624 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM | March 17, 2004 |
| K031400 | FABIUS TIRO ANESTHESIA SYSTEM | July 15, 2003 |
| K022031 | NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 | August 29, 2002 |
| K011404 | FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS | February 22, 2002 |
| K012139 | VAMOS ANESTHETIC GAS MONITOR | January 17, 2002 |
| K003579 | NARKOMED MRI-2, MODEL NM-MRI-2 | January 22, 2001 |
| K001488 | NARKOMED MRI , NM-MRI | June 9, 2000 |