Edwards Lifesciences, LLC
59 FDA actions
Respiration Rate algorithm
Edwards Lifesciences, LLC
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Edwards Lifesciences, LLC
HemoSphere Nano Monitor (HSNANO1)
Edwards Lifesciences, LLC
Edwards MC3 Tricuspid annuloplasty ring (4900)
Edwards Lifesciences, LLC
Carpentier-Edwards Physio Annuloplasty Ring (4450)
Edwards Lifesciences, LLC
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software V
Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A
Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A
Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A
Edwards Lifesciences, LLC
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A
Edwards Lifesciences, LLC
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software V
Edwards Lifesciences, LLC
Hypertension Prediction Index (HePI) Algorithm
Edwards Lifesciences, LLC
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
Edwards Lifesciences, LLC
Swan-Ganz catheter
Edwards Lifesciences, LLC
Fogarty Venous Thrombectomy Catheters
Edwards Lifesciences, LLC
Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monit
Edwards Lifesciences, LLC
TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284
Edwards Lifesciences, LLC
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure mo
Edwards Lifesciences, LLC
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK036
Edwards Lifesciences, LLC
FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure mo
Edwards Lifesciences, LLC
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravas
Edwards Lifesciences, LLC
Edwards Algorithm for Measurement of Blood Hemoglobin
Edwards Lifesciences, LLC
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Edwards Lifesciences, LLC
HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advan
Edwards Lifesciences, LLC
Acumen IQ finger cuff
Edwards Lifesciences, LLC
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Edwards Lifesciences, LLC
Smart Wedge algorithm
Edwards Lifesciences, LLC
Global Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences, LLC
FusedCO Algorithm
Edwards Lifesciences, LLC
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen
Edwards Lifesciences, LLC
Acumen Hypotension Prediction Index (HPI) Algorithm
Edwards Lifesciences, LLC
Cerebral Adaptive Index (CAI) Algorithm
Edwards Lifesciences, LLC
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F
Edwards Lifesciences, LLC
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.
Edwards Lifesciences, LLC
TruWave Disposable Pressure Transducer
Edwards Lifesciences, LLC
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
Edwards Lifesciences, LLC
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 12080
Edwards Lifesciences, LLC
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Edwards Lifesciences, LLC
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
Edwards Lifesciences, LLC
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
Edwards Lifesciences, LLC
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphe
Edwards Lifesciences, LLC
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Edwards Lifesciences, LLC
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Edwards Lifesciences, LLC
Fogarty Occlusion Catheter
Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3,
Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lu
Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of
Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of
Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3,
Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx
Edwards Lifesciences, LLC
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
Edwards Lifesciences, LLC
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, St
Edwards Lifesciences, LLC
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Edwards Lifesciences, LLC
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)5746069
Edwards Lifesciences, LLC
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
Edwards Lifesciences, LLC
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
Edwards Lifesciences, LLC
Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Ste
Edwards Lifesciences, LLC
Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
Edwards Lifesciences, LLC
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Steri
Edwards Lifesciences, LLC