CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VAMP Venous/Arterial Blood Management Protection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fogarty Thru-Lumen Embolectomy Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXILLARY ACCESS ARTERIAL CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P

FDA 510(k)

FDA Class 2 ·Cardiovascular

FusedCO Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitor, HemoSphere Pressure Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDWARDS E360 SURGICAL ABLATION DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fogarty Venous Thrombectomy Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMBOL-X INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular