{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 49
    }
  },
  "results": [
    {
      "proprietary_name": [
        "ENSITE-SW-1.1 EnSite X EP System Software Upgrade",
        "ENSITE-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set",
        "ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart",
        "ENSITE-R-DWS-1.1 EnSite X EP System Display WorkStation",
        "ENSITE-AMP-02 EnSite X EP System Amplifier",
        "ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License",
        "ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License",
        "ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License",
        "ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor",
        "ENSITE-TF-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software License",
        "ENSITE-ACBL-160-01 EnSite X EP System Connect Cable",
        "ENSITE-WM64-144-01 EnSite X EP System IC Output Cable",
        "EnSite X EP System Level Order Number ENSITE-SYSTEM-201",
        "ENSITE-DWSCART-01 EnSite X EP System Display Workstation Cart",
        "ENSITE-PRSBACK-01 EnSite X EP System Patient Reference Sensor",
        "ENSITE-D-LV-01 EnSite X EP System EnSite LiveView Dynamic Display Demo Software License",
        "ENSITE-CF-01 EnSite X EP System Contact Force Software License",
        "ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module",
        "ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart",
        "ENSITE-D-CF-01 EnSite X EP System Contact Force Software License",
        "ENSITE-WM64-60-01 EnSite X EP System IC Output Cable",
        "ENSITE-CR-56-01 EnSite X EP System Recording System IC Output Cable",
        "EnSite X EP System Level Order Number ENSITE-SYSTEM-111",
        "ENSITE-ECGRL-01 EnSite X EP System Radio-lucent ECG Lead set",
        "ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable",
        "ENSITE-WM56-144-01 EnSite X EP System IC Output Cable",
        "ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License",
        "ENSITE-WM56-60-01 EnSite X EP System IC Output Cable",
        "ENSITE-AMP-01 EnSite X EP System Amplifier",
        "ENSITE-FF-01 EnSite X EP System Field Frame",
        "ENSITE-R-FF-01 EnSite X EP System Field Frame",
        "ENSITE-R-AMP-01 EnSite X EP System Amplifier",
        "ENSITE-WS-01 EnSite X EP System Wave Speed Map Software License",
        "ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation",
        "ENSITE-DWS-1.1 EnSite X EP System Display Workstation",
        "ENSITE-DWS-2.1 EnSite X EP System Display Workstation",
        "ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand",
        "ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount",
        "ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade",
        "ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module",
        "ENSITE-SW-2.1 EnSite X EP System Software Upgrade",
        "ENSITE-ACBL-60-01 EnSite X EP System Connect Cable",
        "ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit",
        "ENSITE-OT-01 EnSite X EP System EnSite Omnipolar Technology Software License",
        "ENSITE-SW-2 EnSite X EP System Software Upgrade",
        "ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module",
        "ENSITE-SW-1.2 EnSite X EP System Software Upgrade",
        "ENSITE-FF-ABRKT-01 EnSite Adjustable Field Frame Bracket",
        "ENSITE-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License",
        "ENSITE-LE-01 EnSite X EP System Live Export Software License",
        "ENSITE-MONPOLE-01 EnSite X EP System Monitor Pole",
        "ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount",
        "ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit",
        "ENSITE-R-DWS-01 EnSite X EP System Display Workstation",
        "ENSITE-CECG-144-01 EnSite X EP System ECG Cable",
        "ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module",
        "ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License",
        "ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable",
        "ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable",
        "ENSITE-CECG-60-01 EnSite X EP System ECG Cable",
        "ENSITE-DWS-01 EnSite X EP System Display Workstation",
        "ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket",
        "ENSITE-TFM-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade",
        "ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License",
        "ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module",
        "ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License",
        "ENSITE-R-AMP-02 EnSite X EP System Amplifier",
        "ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "2184149",
        "fei_number": "1000139754",
        "status_code": "1",
        "initial_importer_flag": "Y",
        "reg_expiry_date_year": "2026",
        "name": "St. Jude Medical, Atrial Fibrillation Division, Inc.",
        "address_line_1": "One St. Jude Medical Drive",
        "address_line_2": "",
        "city": "Saint Paul",
        "state_code": "MN",
        "iso_country_code": "US",
        "zip_code": "55117",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "ABBOTT LABORATORIES",
          "owner_operator_number": "1415939",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "100 ABBOTT PARK RD.",
            "address_2": "D-03Q3, AP52-1",
            "city": "Abbott Park",
            "state_code": "IL",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "60064"
          }
        }
      },
      "pma_number": "",
      "k_number": "K223094",
      "products": [
        {
          "product_code": "DQK",
          "created_date": "2023-02-02",
          "owner_operator_number": "1415939",
          "exempt": "",
          "openfda": {
            "device_name": "Computer, Diagnostic, Programmable",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.1425",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}