Del Mar Reynolds Medical, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 8 (3 Class I)
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2093-2017 | Class II | Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environmen | April 14, 2017 |
| Z-1460-2017 | Class II | Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon A | February 8, 2017 |
| Z-1458-2015 | Class II | Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 70 | March 5, 2015 |
| Z-1442-2014 | Class I | SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system include | March 10, 2014 |
| Z-0352-2014 | Class I | CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesth | October 17, 2013 |
| Z-1771-2013 | Class II | Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for t | June 7, 2013 |
| Z-0968-2013 | Class I | Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Abso | January 15, 2013 |
| Z-0565-2013 | Class II | BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In | November 2, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K062397 | SENTINEL | January 25, 2007 |
| K062469 | VOYAGER 12 | November 3, 2006 |
| K051960 | CARDIONAVIGATOR + | August 19, 2005 |
| K042745 | LIFESCREEN APNEA | January 19, 2005 |
| K040313 | HRV TOOLS | April 6, 2004 |