Edwards Lifesciences
FDA 510(k) medical device clearances.
Top product codes for Edwards Lifesciences
Recent clearances by Edwards Lifesciences
- K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
- K253034 — HemoSphere Stream Module
- K252364 — Edwards eSheath Optima introducer set
- K243781 — 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)
- K244046 — Edwards eSheath Optima introducer set
- K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)
- K240596 — Cerebral Autoregulation Index (CAI) Algorithm
- K241330 — Fogarty Fortis Arterial Embolectomy Catheter
- K233983 — Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
- K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve
- K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
- K233895 — EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);
- DEN190029 — Acumen Assisted Fluid Management (AFM) Software Feature
- K200258 — Edwards eSheath Introducer Set
- K153069 — Edwards Balloon Catheter
- K152225 — Edwards eSheath Introducer Set
- K142199 — Ascendra Balloon Aortic Valvaloplasty Catheter
- K141696 — EDWARDS ESHEATH INTRODUCER SET
- K110597 — EV1000 CLINICAL PLATFORM
Data sourced from openFDA. This site is unofficial and independent of the FDA.