{
  "companyId": "60854",
  "slug": "intermedics-inc-60854",
  "name": "Intermedics, Inc.",
  "clearances": {
    "total": 211,
    "last12Months": 0,
    "first": "1977-09-12",
    "latest": "1996-12-16"
  },
  "medianReviewDays": 55,
  "productCodeCount": 23,
  "recalls": {
    "total": 0,
    "openLast12Months": 0,
    "recent": []
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "DTB",
      "deviceName": "Permanent Pacemaker Electrode",
      "clearances": 105,
      "latest": "1996-12-16",
      "medianReviewDays": 73
    },
    {
      "code": "DXY",
      "deviceName": "Implantable Pacemaker Pulse-Generator",
      "clearances": 52,
      "latest": "1992-03-17",
      "medianReviewDays": 39
    },
    {
      "code": "DTD",
      "deviceName": "Pacemaker Lead Adaptor",
      "clearances": 14,
      "latest": "1989-09-05",
      "medianReviewDays": 42
    },
    {
      "code": "FRN",
      "deviceName": "Pump, Infusion",
      "clearances": 7,
      "latest": "1984-11-15",
      "medianReviewDays": 51
    },
    {
      "code": "DXH",
      "deviceName": "Transmitters And Receivers, Electrocardiograph, Telephone",
      "clearances": 5,
      "latest": "1982-07-08",
      "medianReviewDays": 69
    },
    {
      "code": "KRG",
      "deviceName": "Programmer, Pacemaker",
      "clearances": 4,
      "latest": "1995-03-15",
      "medianReviewDays": 77
    },
    {
      "code": "GZJ",
      "deviceName": "Stimulator, Nerve, Transcutaneous, For Pain Relief",
      "clearances": 3,
      "latest": "1985-06-04",
      "medianReviewDays": 80
    },
    {
      "code": "DTE",
      "deviceName": "Pulse-Generator, Pacemaker, External",
      "clearances": 2,
      "latest": "1980-10-31",
      "medianReviewDays": 132
    },
    {
      "code": "GEI",
      "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories",
      "clearances": 2,
      "latest": "1979-09-04",
      "medianReviewDays": 13
    },
    {
      "code": "BXN",
      "deviceName": "Stimulator, Nerve, Battery-Powered",
      "clearances": 1,
      "latest": "1979-02-06",
      "medianReviewDays": 14
    },
    {
      "code": "DBT",
      "deviceName": "Factor Xiii A, S, Antigen, Antiserum, Control",
      "clearances": 1,
      "latest": "1987-09-15",
      "medianReviewDays": 98
    },
    {
      "code": "DRG",
      "deviceName": "Transmitters And Receivers, Physiological Signal, Radiofrequency",
      "clearances": 1,
      "latest": "1981-02-12",
      "medianReviewDays": 139
    },
    {
      "code": "DRT",
      "deviceName": "Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)",
      "clearances": 1,
      "latest": "1982-12-30",
      "medianReviewDays": 55
    },
    {
      "code": "DSA",
      "deviceName": "Cable, Transducer And Electrode, Patient, (Including Connector)",
      "clearances": 1,
      "latest": "1982-03-26",
      "medianReviewDays": 52
    },
    {
      "code": "DTR",
      "deviceName": "Heat-Exchanger, Cardiopulmonary Bypass",
      "clearances": 1,
      "latest": "1985-10-11",
      "medianReviewDays": 59
    },
    {
      "code": "DYB",
      "deviceName": "Introducer, Catheter",
      "clearances": 1,
      "latest": "1981-10-13",
      "medianReviewDays": 42
    },
    {
      "code": "ETN",
      "deviceName": "Stimulator, Nerve",
      "clearances": 1,
      "latest": "1978-12-07",
      "medianReviewDays": 84
    },
    {
      "code": "GDX",
      "deviceName": "Scalpel, One-Piece",
      "clearances": 1,
      "latest": "1979-02-13",
      "medianReviewDays": 7
    },
    {
      "code": "HLM",
      "deviceName": "Instrument, Measuring, Lens, Ac-Powered",
      "clearances": 1,
      "latest": "1979-10-30",
      "medianReviewDays": 81
    },
    {
      "code": "HPS",
      "deviceName": "Unit, Cryophthalmic",
      "clearances": 1,
      "latest": "1979-02-12",
      "medianReviewDays": 27
    },
    {
      "code": "IPF",
      "deviceName": "Stimulator, Muscle, Powered",
      "clearances": 1,
      "latest": "1984-07-03",
      "medianReviewDays": 74
    },
    {
      "code": "JOS",
      "deviceName": "Electrode, Electrosurgical",
      "clearances": 1,
      "latest": "1981-04-03",
      "medianReviewDays": 25
    },
    {
      "code": "KFJ",
      "deviceName": "Materials, Repair Or Replacement, Pacemaker",
      "clearances": 1,
      "latest": "1982-01-12",
      "medianReviewDays": 27
    }
  ],
  "productCodesShown": 23,
  "productCodesTotal": "23",
  "recentClearances": [
    {
      "kNumber": "K954610",
      "deviceName": "MODEL 430-07 ENDOCARDIAL PACING LEAD",
      "productCode": "DTB",
      "decisionDate": "1996-12-16",
      "reviewDays": 439
    },
    {
      "kNumber": "K955122",
      "deviceName": "INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD",
      "productCode": "DTB",
      "decisionDate": "1996-11-04",
      "reviewDays": 361
    },
    {
      "kNumber": "K962174",
      "deviceName": "BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)",
      "productCode": "DTB",
      "decisionDate": "1996-08-21",
      "reviewDays": 77
    },
    {
      "kNumber": "K955550",
      "deviceName": "CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD",
      "productCode": "DTB",
      "decisionDate": "1996-06-19",
      "reviewDays": 197
    },
    {
      "kNumber": "K960281",
      "deviceName": "IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY",
      "productCode": "DTB",
      "decisionDate": "1996-06-18",
      "reviewDays": 151
    },
    {
      "kNumber": "K954719",
      "deviceName": "INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD",
      "productCode": "DTB",
      "decisionDate": "1996-02-27",
      "reviewDays": 137
    },
    {
      "kNumber": "K933278",
      "deviceName": "INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04",
      "productCode": "KRG",
      "decisionDate": "1995-03-15",
      "reviewDays": 624
    },
    {
      "kNumber": "K922042",
      "deviceName": "CARDIFIX  ENDOCARDIAL PACING LEAD",
      "productCode": "DTB",
      "decisionDate": "1993-04-29",
      "reviewDays": 363
    },
    {
      "kNumber": "K922972",
      "deviceName": "MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD",
      "productCode": "DTB",
      "decisionDate": "1993-01-22",
      "reviewDays": 217
    },
    {
      "kNumber": "K920530",
      "deviceName": "INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG",
      "productCode": "DXY",
      "decisionDate": "1992-03-17",
      "reviewDays": 41
    }
  ],
  "nameVariants": {
    "total": "1",
    "shown": [
      {
        "name": "Intermedics, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Intermedics%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Intermedics%2C%20Inc.%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": "2026-08-11T14:48:53.028Z"
}
