Edwards Lifesciences Research Medical
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K073559 | 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II | January 31, 2008 |
| K062429 | MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COA | September 27, 2006 |
| K990396 | T-ANASTAFLO | October 1, 1999 |
| K991170 | RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 | July 2, 1999 |
| K983791 | PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA | June 11, 1999 |
| K974259 | VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE | December 1, 1998 |