{
  "companyId": "48250",
  "slug": "edwards-lifesciences-llc-48250",
  "name": "Edwards Lifesciences, LLC",
  "clearances": {
    "total": 156,
    "last12Months": 10,
    "first": "1979-07-12",
    "latest": "2026-06-26"
  },
  "medianReviewDays": 107,
  "productCodeCount": 40,
  "recalls": {
    "total": 171,
    "openLast12Months": 1,
    "recent": [
      {
        "resNumber": "Z-2172-2026",
        "productCode": "NPW",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-03-27",
        "reason": "Labeling update to provide warning if functionality of the  valve replacement delivery system is compromised."
      },
      {
        "resNumber": "Z-2080-2025",
        "productCode": "DQR",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2025-05-14",
        "reason": "due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body."
      },
      {
        "resNumber": "Z-2081-2025",
        "productCode": "DQR",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2025-05-14",
        "reason": "due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body."
      },
      {
        "resNumber": "Z-2082-2025",
        "productCode": "DQR",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2025-05-14",
        "reason": "due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body."
      },
      {
        "resNumber": "Z-2083-2025",
        "productCode": "DQR",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2025-05-14",
        "reason": "due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body."
      }
    ]
  },
  "registration": {
    "sites": 4,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "DWF",
      "deviceName": "Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass",
      "clearances": 19,
      "latest": "2024-02-05",
      "medianReviewDays": 119
    },
    {
      "code": "DQK",
      "deviceName": "Computer, Diagnostic, Programmable",
      "clearances": 15,
      "latest": "2026-02-24",
      "medianReviewDays": 162
    },
    {
      "code": "DYB",
      "deviceName": "Introducer, Catheter",
      "clearances": 14,
      "latest": "2026-04-17",
      "medianReviewDays": 87
    },
    {
      "code": "DXG",
      "deviceName": "Computer, Diagnostic, Pre-Programmed, Single-Function",
      "clearances": 11,
      "latest": "2019-12-17",
      "medianReviewDays": 104
    },
    {
      "code": "DXN",
      "deviceName": "System, Measurement, Blood-Pressure, Non-Invasive",
      "clearances": 9,
      "latest": "2023-10-24",
      "medianReviewDays": 126
    },
    {
      "code": "KRH",
      "deviceName": "Ring, Annuloplasty",
      "clearances": 9,
      "latest": "2025-09-23",
      "medianReviewDays": 88
    },
    {
      "code": "FGE",
      "deviceName": "Stents, Drains And Dilators For The Biliary Ducts",
      "clearances": 7,
      "latest": "2006-06-05",
      "medianReviewDays": 27
    },
    {
      "code": "DXE",
      "deviceName": "Catheter, Embolectomy",
      "clearances": 6,
      "latest": "2024-08-28",
      "medianReviewDays": 173
    },
    {
      "code": "DXC",
      "deviceName": "Clamp, Vascular",
      "clearances": 5,
      "latest": "2026-06-05",
      "medianReviewDays": 40
    },
    {
      "code": "DXO",
      "deviceName": "Transducer, Pressure, Catheter Tip",
      "clearances": 5,
      "latest": "2022-12-22",
      "medianReviewDays": 112
    },
    {
      "code": "DYG",
      "deviceName": "Catheter, Flow Directed",
      "clearances": 5,
      "latest": "2024-12-09",
      "medianReviewDays": 115
    },
    {
      "code": "DQE",
      "deviceName": "Catheter, Oximeter, Fiber-Optic",
      "clearances": 4,
      "latest": "2016-06-16",
      "medianReviewDays": 63
    },
    {
      "code": "KRA",
      "deviceName": "Catheter, Continuous Flush",
      "clearances": 4,
      "latest": "2018-11-08",
      "medianReviewDays": 135
    },
    {
      "code": "MUD",
      "deviceName": "Oximeter, Tissue Saturation",
      "clearances": 4,
      "latest": "2024-10-16",
      "medianReviewDays": 171
    },
    {
      "code": "DQY",
      "deviceName": "Catheter, Percutaneous",
      "clearances": 3,
      "latest": "2005-09-02",
      "medianReviewDays": 41
    },
    {
      "code": "DRS",
      "deviceName": "Transducer, Blood-Pressure, Extravascular",
      "clearances": 3,
      "latest": "2025-03-21",
      "medianReviewDays": 102
    },
    {
      "code": "FOZ",
      "deviceName": "Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days",
      "clearances": 3,
      "latest": "2012-05-18",
      "medianReviewDays": 125
    },
    {
      "code": "MJN",
      "deviceName": "Catheter, Intravascular Occluding, Temporary",
      "clearances": 3,
      "latest": "2022-02-14",
      "medianReviewDays": 60
    },
    {
      "code": "QAQ",
      "deviceName": "Adjunctive Predictive Cardiovascular Indicator",
      "clearances": 3,
      "latest": "2025-05-15",
      "medianReviewDays": 265
    },
    {
      "code": "DQO",
      "deviceName": "Catheter, Intravascular, Diagnostic",
      "clearances": 2,
      "latest": "2011-02-11",
      "medianReviewDays": 29
    },
    {
      "code": "LDF",
      "deviceName": "Electrode, Pacemaker, Temporary",
      "clearances": 2,
      "latest": "2015-10-15",
      "medianReviewDays": 17
    },
    {
      "code": "OZT",
      "deviceName": "Balloon Aortic Valvuloplasty",
      "clearances": 2,
      "latest": "2014-10-29",
      "medianReviewDays": 79
    },
    {
      "code": "BZQ",
      "deviceName": "Monitor, Breathing Frequency",
      "clearances": 1,
      "latest": "2026-06-11",
      "medianReviewDays": 408
    },
    {
      "code": "DRE",
      "deviceName": "Dilator, Vessel, For Percutaneous Catheterization",
      "clearances": 1,
      "latest": "2010-04-13",
      "medianReviewDays": 147
    },
    {
      "code": "DSY",
      "deviceName": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter",
      "clearances": 1,
      "latest": "2003-12-04",
      "medianReviewDays": 78
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "40",
  "recentClearances": [
    {
      "kNumber": "K254232",
      "deviceName": "ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)",
      "productCode": "PZX",
      "decisionDate": "2026-06-26",
      "reviewDays": 179
    },
    {
      "kNumber": "K251326",
      "deviceName": "Respiration Rate algorithm",
      "productCode": "BZQ",
      "decisionDate": "2026-06-11",
      "reviewDays": 408
    },
    {
      "kNumber": "K260105",
      "deviceName": "Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts",
      "productCode": "DXC",
      "decisionDate": "2026-06-05",
      "reviewDays": 143
    },
    {
      "kNumber": "K254279",
      "deviceName": "Edwards eSheath+ introducer set",
      "productCode": "DYB",
      "decisionDate": "2026-04-17",
      "reviewDays": 108
    },
    {
      "kNumber": "K253186",
      "deviceName": "HemoSphere Nano Monitor (HSNANO1)",
      "productCode": "DQK",
      "decisionDate": "2026-02-24",
      "reviewDays": 151
    },
    {
      "kNumber": "K252533",
      "deviceName": "HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)",
      "productCode": "DQK",
      "decisionDate": "2025-12-18",
      "reviewDays": 128
    },
    {
      "kNumber": "K253034",
      "deviceName": "HemoSphere Stream Module",
      "productCode": "DQK",
      "decisionDate": "2025-10-21",
      "reviewDays": 29
    },
    {
      "kNumber": "K251982",
      "deviceName": "Edwards MC3 Tricuspid annuloplasty ring (4900)",
      "productCode": "KRH",
      "decisionDate": "2025-09-23",
      "reviewDays": 88
    },
    {
      "kNumber": "K251688",
      "deviceName": "Carpentier-Edwards Physio Annuloplasty Ring (4450)",
      "productCode": "KRH",
      "decisionDate": "2025-09-17",
      "reviewDays": 107
    },
    {
      "kNumber": "K252364",
      "deviceName": "Edwards eSheath Optima introducer set",
      "productCode": "DYB",
      "decisionDate": "2025-08-29",
      "reviewDays": 31
    }
  ],
  "nameVariants": {
    "total": "11",
    "shown": [
      {
        "name": "EDWARDS LIFESCIENCES LLC",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Edwards Lifesciences",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Edwards Lifesciences",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Edwards Lifesciences AG",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Edwards Lifesciences LLC",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Edwards Lifesciences LTD",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Edwards Lifesciences Llc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Edwards Lifesciences, LLC",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Edwards%20Lifesciences%2C%20LLC%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Edwards%20Lifesciences%2C%20LLC%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.033Z"
}
