Edwards Lifesciences Research Medical

FDA Regulatory Profile

Edwards Lifesciences Research Medical appears in FDA public data with 0 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on January 31, 2008.

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIJanuary 31, 2008
K062429MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COASeptember 27, 2006
K990396T-ANASTAFLOOctober 1, 1999
K991170RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014July 2, 1999
K983791PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULAJune 11, 1999
K974259VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAEDecember 1, 1998