| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
| HemoSphere Nano Monitor (HSNANO1) (K253186) | Edwards Lifesciences, LLC | 2026-02-24 |
| Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982) | Edwards Lifesciences, LLC | 2025-09-23 |
| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
| Hypertension Prediction Index (HePI) Algorithm (K242518) | Edwards Lifesciences, LLC | 2025-05-15 |
| FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909) | Edwards Lifesciences, LLC | 2025-03-21 |
| Fogarty Thru-Lumen Embolectomy Catheter (K240078) | Edwards Lifesciences, LLC | 2024-08-28 |
| Acumen Assisted Fluid Management (AFM) Software Feature (K233984) | Edwards Lifesciences, LLC | 2024-08-02 |
| Swan-Ganz catheter (K233824) | Edwards Lifesciences, LLC | 2024-06-06 |
| Fogarty Venous Thrombectomy Catheters (K233819) | Edwards Lifesciences, LLC | 2024-05-22 |
| Edwards Algorithm for Measurement of Blood Hemoglobin (K230612) | Edwards Lifesciences, LLC | 2023-11-17 |
| HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One) (K232294) | Edwards Lifesciences, LLC | 2023-10-31 |
| Acumen IQ finger cuff (K230919) | Edwards Lifesciences, LLC | 2023-10-24 |
| Smart Wedge algorithm (K230579) | Edwards Lifesciences, LLC | 2023-08-18 |
| Global Hypoperfusion Index (GHI) Algorithm (K231038) | Edwards Lifesciences, LLC | 2023-07-26 |
| FusedCO Algorithm (K231035) | Edwards Lifesciences, LLC | 2023-07-12 |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor (K223865) | Edwards Lifesciences, LLC | 2023-06-09 |
| Acumen Hypotension Prediction Index (HPI) Algorithm (K230057) | Edwards Lifesciences, LLC | 2023-06-08 |
| Cerebral Adaptive Index (CAI) Algorithm (K223651) | Edwards Lifesciences, LLC | 2023-05-26 |
| TruWave Disposable Pressure Transducer (K222216) | Edwards Lifesciences, LLC | 2022-12-22 |
| HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) (K221704) | Edwards Lifesciences, LLC | 2022-11-22 |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module (K221833) | Edwards Lifesciences, LLC | 2022-11-07 |
| Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter (K221528) | Edwards Lifesciences, LLC | 2022-08-22 |
| HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote (K213682) | Edwards Lifesciences, LLC | 2022-06-22 |
| Fogarty Occlusion Catheter (K211610) | Edwards Lifesciences, LLC | 2022-02-14 |
| Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform (K203224) | Edwards Lifesciences, LLC | 2021-07-30 |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (K203687) | Edwards Lifesciences, LLC | 2021-05-28 |
| FORE-SIGHT ELITE Absolute Tissue Oximeter (K203490) | Edwards Lifesciences, LLC | 2021-02-10 |
| EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform (K203131) | Edwards Lifesciences, LLC | 2021-01-22 |
| Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (K193379) | Edwards Lifesciences, LLC | 2020-06-12 |
| QuickDraw Venous Cannula (K200499) | Edwards Lifesciences, LLC | 2020-03-29 |
| Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula (K200358) | Edwards Lifesciences, LLC | 2020-03-13 |
| Swan-Ganz Catheters (K193466) | Edwards Lifesciences, LLC | 2020-02-16 |
| EV1000 Clinical Platform (K193179) | Edwards Lifesciences, LLC | 2019-12-17 |
| Physio Flex Annuloplasty Ring (K192762) | Edwards Lifesciences, LLC | 2019-12-16 |
| EV1000 Clinical Platform NI, EV1000 Clinical Platform (K192058) | Edwards Lifesciences, LLC | 2019-08-30 |
| HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (K190205) | Edwards Lifesciences, LLC | 2019-08-29 |
| The ClearSight finger cuffs (K190130) | Edwards Lifesciences, LLC | 2019-06-21 |
| Edwards Pressure Cable (K191089) | Edwards Lifesciences, LLC | 2019-06-13 |
| EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System (K182245) | Edwards Lifesciences, LLC | 2018-11-30 |
| HemoSphere Advanced Monitor, HemoSphere Pressure Cable (K180881) | Edwards Lifesciences, LLC | 2018-11-16 |
| VAMP Plus Venous/Arterial Blood Management Protection System (K181684) | Edwards Lifesciences, LLC | 2018-11-08 |
| VAMP Optima closed blood sampling system (K180275) | Edwards Lifesciences, LLC | 2018-10-24 |
| VAMP Venous/Arterial Blood Management Protection System (K173586) | Edwards Lifesciences, LLC | 2018-04-05 |
| Acumen Hypotension Prediction Index (HPI) Feature Software (DEN160044) | Edwards Lifesciences, LLC | 2018-03-16 |
| Duravess bovine pericardial vascular patch (K172660) | Edwards Lifesciences, LLC | 2017-11-17 |
| TruWave Disposable Pressure Transducer (K171996) | Edwards Lifesciences, LLC | 2017-10-23 |
| HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable (K163381) | Edwards Lifesciences, LLC | 2017-04-14 |
| IntraClude Intra-Aortic Occlusion Device (K163693) | Edwards Lifesciences, LLC | 2017-01-26 |
| VAMP Venous/Arterial Blood Management Protection System (K161962) | Edwards Lifesciences, LLC | 2016-11-28 |
| PreSep Oligon Oximetry Catheter (K160645) | Edwards Lifesciences, LLC | 2016-06-16 |
| EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform (K160552) | Edwards Lifesciences, LLC | 2016-06-01 |
| Swan Ganz Catheters (K160084) | Edwards Lifesciences, LLC | 2016-05-03 |
| Flo Trac sensor, Volume View sensor (K152980) | Edwards Lifesciences, LLC | 2016-01-19 |
| Fogarty Occlusion Catheter (K152762) | Edwards Lifesciences, LLC | 2015-11-23 |
| Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe (K152633) | Edwards Lifesciences, LLC | 2015-10-15 |
| Edwards Suture Fastening System (K150882) | Edwards Lifesciences, LLC | 2015-06-16 |
| TruWave Disposable Pressure Transducer (K142749) | Edwards Lifesciences, LLC | 2015-01-18 |
| EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM (K141206) | Edwards Lifesciences, LLC | 2015-01-16 |
| TRUWAVE DISPOSABLE PRESSURE TRANSDUCER (K141495) | Edwards Lifesciences, LLC | 2014-09-03 |
| EDWARDS TRANSFEMORAL BALLOON CATHETER (K140241) | Edwards Lifesciences, LLC | 2014-07-03 |
| EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM (K140312) | Edwards Lifesciences, LLC | 2014-06-13 |
| EV1000 CLINICAL PLATFORM (K131892) | Edwards Lifesciences, LLC | 2014-05-22 |
| VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR (K131588) | Edwards Lifesciences, LLC | 2014-05-22 |
| EMBOL-X INTRODUCER SHEATH (K140398) | Edwards Lifesciences, LLC | 2014-03-19 |
| CATHETER INTRODUCER SHEATH (K131627) | Edwards Lifesciences, LLC | 2014-03-06 |
| FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII (K140208) | Edwards Lifesciences, LLC | 2014-03-05 |
| EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER (K132175) | Edwards Lifesciences, LLC | 2013-09-13 |
| EDWARDS EMBOL-X INTRODUCER SHEATH (K123714) | Edwards Lifesciences, LLC | 2013-07-24 |
| NEXFIN MODEL 2 (K122381) | Edwards Lifesciences, LLC | 2013-04-22 |
| FEMORAL ACCESS VENOUS CANNULAE (K123303) | Edwards Lifesciences, LLC | 2013-03-22 |
| FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING (K123298) | Edwards Lifesciences, LLC | 2013-03-15 |
| EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA (K123370) | Edwards Lifesciences, LLC | 2013-03-13 |
| RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA (K123187) | Edwards Lifesciences, LLC | 2013-02-22 |
| EDWARDS PERCUTANEOUS SHEATH INTRODUCER (K121185) | Edwards Lifesciences, LLC | 2012-08-22 |
| ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING (K113459) | Edwards Lifesciences, LLC | 2012-06-29 |
| EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE (K120780) | Edwards Lifesciences, LLC | 2012-06-27 |
| EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA (K113411) | Edwards Lifesciences, LLC | 2012-06-11 |
| MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN (K113565) | Edwards Lifesciences, LLC | 2012-05-18 |
| VENOUS DRAINAGE CANNULA WITH DURAFLO COATING (K120072) | Edwards Lifesciences, LLC | 2012-05-08 |
| CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING (K113667) | Edwards Lifesciences, LLC | 2012-01-12 |
| EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER (K113182) | Edwards Lifesciences, LLC | 2011-12-07 |
| EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER (K112694) | Edwards Lifesciences, LLC | 2011-10-14 |
| CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING (K103520) | Edwards Lifesciences, LLC | 2011-06-24 |
| VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR (K103094) | Edwards Lifesciences, LLC | 2011-05-17 |
| PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (K110167) | Edwards Lifesciences, LLC | 2011-02-18 |
| EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER (K110103) | Edwards Lifesciences, LLC | 2011-02-11 |
| VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 (K100739) | Edwards Lifesciences, LLC | 2010-12-07 |
| EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M (K100709) | Edwards Lifesciences, LLC | 2010-12-07 |
| EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA (K102420) | Edwards Lifesciences, LLC | 2010-10-26 |
| RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 (K093877) | Edwards Lifesciences, LLC | 2010-07-01 |
| RETROFLEX DILATOR KIT (K093554) | Edwards Lifesciences, LLC | 2010-04-13 |
| FOGARTY OCCLUSION CATHETER (K093911) | Edwards Lifesciences, LLC | 2010-01-21 |
| PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) (K093730) | Edwards Lifesciences, LLC | 2010-01-14 |
| MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC (K091709) | Edwards Lifesciences, LLC | 2009-10-13 |
| EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE (K092509) | Edwards Lifesciences, LLC | 2009-10-08 |
| CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 (K083623) | Edwards Lifesciences, LLC | 2009-04-15 |
| DETLOGIX ANNULOPLASTY RING, MODEL: 5100 (K083191) | Edwards Lifesciences, LLC | 2009-04-10 |
| CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 (K083470) | Edwards Lifesciences, LLC | 2009-01-23 |
| MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K082308) | Edwards Lifesciences, LLC | 2008-12-09 |