ClearanceBrief
Company · US

Edwards Lifesciences, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2026. Name variants (Inc, Corp, punctuation) are merged.

158510(k) clearances (6 in 12 months)
172recalls (2 in 12 months)
148recalls that name a 510(k)

Product codes

CodeDeviceRecords
FGEStents, Drains And Dilators For The Biliary Ducts59
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass40
DYGCatheter, Flow Directed25
DQKComputer, Diagnostic, Programmable17
DYBIntroducer, Catheter15
DXGComputer, Diagnostic, Pre-Programmed, Single-Function14
DXOTransducer, Pressure, Catheter Tip14
DQECatheter, Oximeter, Fiber-Optic11
DXNSystem, Measurement, Blood-Pressure, Non-Invasive11
DRSTransducer, Blood-Pressure, Extravascular10
DXECatheter, Embolectomy10
KRACatheter, Continuous Flush10
NPTAortic Valve, Prosthesis, Percutaneously Delivered10
DXCClamp, Vascular9
KRHRing, Annuloplasty9
DQRCannula, Catheter6
MUDOximeter, Tissue Saturation6
DQOCatheter, Intravascular, Diagnostic4
MJNCatheter, Intravascular Occluding, Temporary4
QAQAdjunctive Predictive Cardiovascular Indicator4

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 26, 2026K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLI
Edwards Lifesciences
PZX
Jun 11, 2026K251326Respiration Rate algorithm
Edwards Lifesciences, LLC
BZQ
Jun 5, 2026K260105Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
Edwards Lifesciences
DXC
Apr 17, 2026K254279Edwards eSheath+ introducer set
Edwards Lifesciences
DYB
Feb 24, 2026K253186HemoSphere Nano Monitor (HSNANO1)
Edwards Lifesciences, LLC
DQK
Dec 18, 2025K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
Edwards Lifesciences
DQK
Oct 21, 2025K253034HemoSphere Stream Module
Edwards Lifesciences
DQK
Sep 23, 2025K251982Edwards MC3 Tricuspid annuloplasty ring (4900)
Edwards Lifesciences, LLC
KRH
Sep 17, 2025K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)
Edwards Lifesciences, LLC
KRH
Aug 29, 2025K252364Edwards eSheath Optima introducer set
Edwards Lifesciences
DYB
Jul 23, 2025K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Sm
Edwards Lifesciences
DQK
May 15, 2025K242518Hypertension Prediction Index (HePI) Algorithm
Edwards Lifesciences, LLC
QAQ
Mar 27, 2025K244046Edwards eSheath Optima introducer set
Edwards Lifesciences
DYB
Mar 21, 2025K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
Edwards Lifesciences, LLC
DRS
Dec 9, 2024K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC
Edwards Lifesciences
DYG
Oct 16, 2024K240596Cerebral Autoregulation Index (CAI) Algorithm
Edwards Lifesciences
MUD
Aug 28, 2024K240078Fogarty Thru-Lumen Embolectomy Catheter
Edwards Lifesciences, LLC
DXE
Aug 2, 2024K233984Acumen Assisted Fluid Management (AFM) Software Feature
Edwards Lifesciences, LLC
QMS
Jul 2, 2024K241330Fogarty Fortis Arterial Embolectomy Catheter
Edwards Lifesciences
DXE
Jun 27, 2024K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D
Edwards Lifesciences
DYG
Jun 6, 2024K233824Swan-Ganz catheter
Edwards Lifesciences, LLC
DYG
May 22, 2024K233820Fogarty Arterial Embolectomy Catheter with Gate Valve
Edwards Lifesciences
DXE
May 22, 2024K233819Fogarty Venous Thrombectomy Catheters
Edwards Lifesciences, LLC
DXE
May 20, 2024K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
Edwards Lifesciences
DXE
Feb 5, 2024K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA,
Edwards Lifesciences
DWF
Nov 17, 2023K230612Edwards Algorithm for Measurement of Blood Hemoglobin
Edwards Lifesciences, LLC
MUD
Oct 31, 2023K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advan
Edwards Lifesciences, LLC
DQK
Oct 24, 2023K230919Acumen IQ finger cuff
Edwards Lifesciences, LLC
DXN
Aug 18, 2023K230579Smart Wedge algorithm
Edwards Lifesciences, LLC
DQK
Jul 26, 2023K231038Global Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences, LLC
QNL
Jul 12, 2023K231035FusedCO Algorithm
Edwards Lifesciences, LLC
DQK
Jun 9, 2023K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen
Edwards Lifesciences, LLC
DQK
Jun 8, 2023K230057Acumen Hypotension Prediction Index (HPI) Algorithm
Edwards Lifesciences, LLC
QAQ
May 26, 2023K223651Cerebral Adaptive Index (CAI) Algorithm
Edwards Lifesciences, LLC
MUD
Dec 22, 2022K222216TruWave Disposable Pressure Transducer
Edwards Lifesciences, LLC
DXO
Nov 22, 2022K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
Edwards Lifesciences, LLC
DQK
Nov 7, 2022K221833HemoSphere Advanced Monitor, HemoSphere ClearSight Module
Edwards Lifesciences, LLC
DXN
Aug 22, 2022K221528Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
Edwards Lifesciences, LLC
DXF
Jun 22, 2022K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphe
Edwards Lifesciences, LLC
DQK
Feb 14, 2022K211610Fogarty Occlusion Catheter
Edwards Lifesciences, LLC
MJN
Jul 30, 2021K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
Edwards Lifesciences, LLC
QAQ
May 28, 2021K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
Edwards Lifesciences, LLC
DQK
Feb 10, 2021K203490FORE-SIGHT ELITE Absolute Tissue Oximeter
Edwards Lifesciences, LLC
MUD
Jan 22, 2021K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
Edwards Lifesciences, LLC
DXN
Nov 13, 2020DEN190029Acumen Assisted Fluid Management (AFM) Software Feature
Edwards Lifesciences
QMS
Jun 12, 2020K193379Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
Edwards Lifesciences, LLC
DXE
Mar 29, 2020K200499QuickDraw Venous Cannula
Edwards Lifesciences, LLC
DWF
Mar 13, 2020K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous
Edwards Lifesciences, LLC
DWF
Mar 9, 2020K200258Edwards eSheath Introducer Set
Edwards Lifesciences
DYB
Feb 16, 2020K193466Swan-Ganz Catheters
Edwards Lifesciences, LLC
DYG

Newest 50 of 158.

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 2, 2026Edwards Lifesciences, LLC
Generic Name: Edwards Commander M Delivery System Generic Name: Edwards Commander M Delivery System Model/Catalog Number: 9880CM29A Software Version: Not applicable. Product Description: Prosthesis, m
Open, Classified
NPUNone listed
May 13, 2026Edwards Lifesciences, LLC
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Open, Classified
NPWNone listed
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or
Open, Classified
DQRK140208
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or e
Open, Classified
DQRK140208
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or
Open, Classified
DQRK140208
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or e
Open, Classified
DQRK140208
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Per
Open, Classified
DQRK073559
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Per
Open, Classified
DQRK073559
Nov 29, 2023Edwards Lifesciences, LLC
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAM
Open, Classified
DRSK142749
K181684 +2
Nov 29, 2023Edwards Lifesciences, LLC
TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX
Open, Classified
DRSK142749
K171996 +1
Nov 29, 2023Edwards Lifesciences, LLC
FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.
Open, Classified
DRSK152980
Nov 29, 2023Edwards Lifesciences, LLC
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Open, Classified
DRSK152980
Nov 29, 2023Edwards Lifesciences, LLC
Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Open, Classified
DRSK152980
Nov 29, 2023Edwards Lifesciences, LLC
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
Open, Classified
DRSK152980
Nov 6, 2023Edwards Lifesciences, LLC
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Open, Classified
DXEK892410
Aug 29, 2023Edwards Lifesciences, LLC
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Open, Classified
NKMNone listed
Apr 12, 2023Edwards Lifesciences, LLC
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimu
Open, Classified
DYGNone listed
Apr 12, 2023Edwards Lifesciences, LLC
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum I
Open, Classified
DYGNone listed
Oct 28, 2022Edwards Lifesciences, LLC
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Open, Classified
DXEK193379
Oct 28, 2022Edwards Lifesciences, LLC
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP
Open, Classified
DXEK193379
Mar 1, 2022Edwards Lifesciences, LLC
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Open, Classified
MUDK180003
K201446
Mar 1, 2022Edwards Lifesciences, LLC
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Open, Classified
MUDK143675
K203490
Jul 9, 2021Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US
Terminated
DQEK053609
Jul 9, 2021Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01
Terminated
DQEK053609
Jul 9, 2021Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO,
Terminated
DQEK053609
Jul 9, 2021Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
Terminated
DQEK053609
Jul 9, 2021Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI:
Terminated
DQEK053609
Jul 9, 2021Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI
Terminated
DQEK053609
May 26, 2021Edwards Lifesciences, LLC
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
Terminated
DXOK142749
K161962
May 26, 2021Edwards Lifesciences, LLC
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Terminated
DXOK142749
K161962
May 26, 2021Edwards Lifesciences, LLC
Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
Terminated
DXOK142749
K161962
May 26, 2021Edwards Lifesciences, LLC
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Terminated
DXOK142749
K161962
May 26, 2021Edwards Lifesciences, LLC
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
Terminated
DXOK142749
K161962
May 26, 2021Edwards Lifesciences, LLC
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within t
Terminated
DXOK142749
K161962
May 26, 2021Edwards Lifesciences, LLC
Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
Terminated
DXOK142749
K161962
May 26, 2021Edwards Lifesciences, LLC
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
Terminated
DXOK142749
K161962
Jul 10, 2020Edwards Lifesciences, LLC
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Terminated
DQEK172423
May 8, 2020Edwards Lifesciences, LLC
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any a
Terminated
DQKK163381
Nov 27, 2019Edwards Lifesciences, LLC
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Terminated
DWFK981995
Oct 22, 2019Edwards Lifesciences, LLC
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174
Terminated
DWFK123370
Aug 21, 2019Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Terminated
NPTNone listed
Aug 21, 2019Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
Terminated
NPTNone listed
Aug 21, 2019Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
Terminated
NPTNone listed
Aug 21, 2019Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
Terminated
NPTNone listed
Jun 11, 2019Edwards Lifesciences, LLC
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing
Terminated
DXCK113182
K132175 +1
May 21, 2019Edwards Lifesciences, LLC
EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sen
Terminated
DXNK160552
Apr 25, 2019Edwards Lifesciences, LLC
Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openi
Terminated
DXFNone listed
Apr 25, 2019Edwards Lifesciences, LLC
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial
Terminated
DXFNone listed
Jan 31, 2019Edwards Lifesciences, LLC
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic press
Terminated
DYGK160084
Jan 31, 2019Edwards Lifesciences, LLC
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pre
Terminated
DYGK160084

Newest 50 of 172.

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