Devices

Name Classification Manufacturer Risk Class Country Source
EDWARDS COMMANDER DELIVERY SYSTEM EDWARDS LIFESCIENCES (CANADA) INC. Canada
EMBOL-X KIT GLIDE CANNNULA WITH SUTRUE FLANGE AND FILTER EDWARDS LIFESCIENCES (CANADA) INC. Canada
EDWARDS TRANSCATHETER MITRAL VALVE REPAIR SYSTEM-GUIDE SHEATH EDWARDS LIFESCIENCES (CANADA) INC. Canada
CONTINUOUS FLUSH DEVICE EDWARDS LIFESCIENCES (CANADA) INC. Canada
EV1000 NI HEART REFERENCE SENSOR EDWARDS LIFESCIENCES (CANADA) INC. Canada
ENDOCLAMP AORTIC CATHETER EDWARDS LIFESCIENCES (CANADA) INC. Canada
FEM-FLEX II VENOUS CANNULA EDWARDS LIFESCIENCES (CANADA) INC. Canada
HEART VENT CATHETER ATRIAL EDWARDS LIFESCIENCES (CANADA) INC. Canada
HEARTPORT KNOT PUSHER EDWARDS LIFESCIENCES (CANADA) INC. Canada
FLOTRAC SENSOR BASE KIT EDWARDS LIFESCIENCES (CANADA) INC. Canada
AQUARIUS SYSTEM EDWARDS LIFESCIENCES (CANADA) INC. Canada
PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCERS EDWARDS LIFESCIENCES (CANADA) INC. Canada
SWAN-GANZ CCO CATHETERS EDWARDS LIFESCIENCES (CANADA) INC. Canada
PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE EDWARDS LIFESCIENCES (CANADA) INC. Canada
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE WITH THERMAFIX EDWARDS LIFESCIENCES (CANADA) INC. Canada
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE WITH THE NOVAFLEX+ DELIVERY SYSTEM AND ACCESSORIES (TRANSFEMORAL APPROACH) EDWARDS LIFESCIENCES (CANADA) INC. Canada
EDWARDS INUITY ELITE EDWARDS LIFESCIENCES (CANADA) INC. Canada
ASCENDRA BALLOON CATHETER EDWARDS LIFESCIENCES (CANADA) INC. Canada
STEERABLE CORONARY SINUS CATHETER EDWARDS LIFESCIENCES (CANADA) INC. Canada
SWAN-GANZ CCO CATHETERS EDWARDS LIFESCIENCES (CANADA) INC. Canada
PERCUTANEOUS SHEATH INTRODUCER KIT EDWARDS LIFESCIENCES (CANADA) INC. Canada
ENDOCLAMP AORTIC CATHETER EDWARDS LIFESCIENCES (CANADA) INC. Canada
VAMP JR PRESSURE MONITORING KIT EDWARDS LIFESCIENCES (CANADA) INC. Canada
ASCENDRA 2 DELIVERY SYSTEM EDWARDS LIFESCIENCES (CANADA) INC. Canada
VASCUSHUNT SILICONE BALLOON SHUNT WITH STOPCOCKS EDWARDS LIFESCIENCES (CANADA) INC. Canada