Catalysts for $EW
78 tracked
Jul 23, 2025
device 510k
Edwards Lifesciences โ HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (510k cleared)
Edwards Lifesciences Corp
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Jul 23, 2025
device pma
Edwards Lifesciences, LLC โ Edwards EVOQUE tricuspid delivery system (PMA supplement)
Edwards Lifesciences Corp
โ
Jul 11, 2025
device pma
Edwards Lifesciences, LLC โ PASCAL Precision Transcatheter Valve Repair System (PMA supplement)
Edwards Lifesciences Corp
โ
Jul 8, 2025
device pma
Edwards Lifesciences, LLC โ Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29) (PMA supplement)
Edwards Lifesciences Corp
โ
Jul 8, 2025
device pma
Edwards Lifesciences, LLC โ Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) (PMA supplement)
Edwards Lifesciences Corp
โ
Jun 26, 2025
device pma
Edwards Lifesciences, LLC โ Edwards Commander Delivery System (PMA supplement)
Edwards Lifesciences Corp
โ
Jun 26, 2025
device pma
Edwards Lifesciences, LLC โ Edwards Commander Delivery System (PMA supplement)
Edwards Lifesciences Corp
โ
Jun 18, 2025
device pma
Edwards Lifesciences, LLC โ Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)
Edwards Lifesciences Corp
โ
Jun 6, 2025
device pma
Edwards Lifesciences, LLC โ EVOQUE Tricuspid Valve Replacement System (PMA supplement)
Edwards Lifesciences Corp
โ
Jun 4, 2025
device pma
Edwards Lifesciences, LLC โ Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 (PMA supplement)
Edwards Lifesciences Corp
โ
Jun 4, 2025
device pma
Edwards Lifesciences, LLC โ Edwards Certitude Delivery System: 9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29 Ed (PMA supplement)
Edwards Lifesciences Corp
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Jun 4, 2025
device pma
Edwards Lifesciences, LLC โ PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (PMA supplement)
Edwards Lifesciences Corp
โ
Jun 4, 2025
device pma
Edwards Lifesciences, LLC โ EVOQUE Tricuspid Delivery System: 9850TDS EVOQUE dilator kit: 9850DK EVOQUE loading system: 9850LS (PMA supplement)
Edwards Lifesciences Corp
โ
May 15, 2025
device 510k
Edwards Lifesciences, LLC โ Hypertension Prediction Index (HePI) Algorithm (510k cleared)
Edwards Lifesciences Corp
โ
Mar 27, 2025
device 510k
Edwards Lifesciences โ Edwards eSheath Optima introducer set (510k cleared)
Edwards Lifesciences Corp
โ
Mar 21, 2025
device 510k
Edwards Lifesciences, LLC โ FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (510k cleared)
Edwards Lifesciences Corp
โ
Dec 9, 2024
device 510k
Edwards Lifesciences โ HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (510k cleared)
Edwards Lifesciences Corp
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Oct 16, 2024
device 510k
Edwards Lifesciences โ Cerebral Autoregulation Index (CAI) Algorithm (510k cleared)
Edwards Lifesciences Corp
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