{
  "companyId": "53773",
  "slug": "medrad-inc-dba-bayer-r-and-i-53773",
  "name": "Medrad Inc dba Bayer R&I",
  "clearances": {
    "total": 105,
    "last12Months": 0,
    "first": "1976-12-10",
    "latest": "2014-08-27"
  },
  "medianReviewDays": 75,
  "productCodeCount": 23,
  "recalls": {
    "total": 30,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1686-2015",
        "productCode": "DXT",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-09-20",
        "reason": "The root cause investigation showed that the under-volume hazard can occur  when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion."
      },
      {
        "resNumber": "Z-1586-2013",
        "productCode": "MWI",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-04-15",
        "reason": "The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket."
      },
      {
        "resNumber": "Z-0870-2013",
        "productCode": "DXT",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2012-11-05",
        "reason": "The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory."
      },
      {
        "resNumber": "Z-0595-2013",
        "productCode": "FRN",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2012-04-18",
        "reason": "Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues."
      },
      {
        "resNumber": "Z-0596-2013",
        "productCode": "FPA",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2012-04-18",
        "reason": "Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161.  The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues."
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
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    {
      "code": "DXT",
      "deviceName": "Injector And Syringe, Angiographic",
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      "latest": "2011-12-15",
      "medianReviewDays": 81
    },
    {
      "code": "MOS",
      "deviceName": "Coil, Magnetic Resonance, Specialty",
      "clearances": 18,
      "latest": "2006-11-30",
      "medianReviewDays": 70
    },
    {
      "code": "LNH",
      "deviceName": "System, Nuclear Magnetic Resonance Imaging",
      "clearances": 16,
      "latest": "1998-11-03",
      "medianReviewDays": 90
    },
    {
      "code": "FRN",
      "deviceName": "Pump, Infusion",
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      "latest": "2010-06-23",
      "medianReviewDays": 72
    },
    {
      "code": "DQO",
      "deviceName": "Catheter, Intravascular, Diagnostic",
      "clearances": 3,
      "latest": "2005-06-07",
      "medianReviewDays": 80
    },
    {
      "code": "DQX",
      "deviceName": "Wire, Guide, Catheter",
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      "latest": "1988-07-28",
      "medianReviewDays": 39
    },
    {
      "code": "LLZ",
      "deviceName": "System, Image Processing, Radiological",
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      "medianReviewDays": 83
    },
    {
      "code": "MCW",
      "deviceName": "Catheter, Peripheral, Atherectomy",
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      "latest": "2014-08-27",
      "medianReviewDays": 30
    },
    {
      "code": "QEZ",
      "deviceName": "Aspiration Thrombectomy Catheter",
      "clearances": 3,
      "latest": "2012-06-06",
      "medianReviewDays": 27
    },
    {
      "code": "DOY",
      "deviceName": "Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.",
      "clearances": 2,
      "latest": "1983-05-09",
      "medianReviewDays": 27
    },
    {
      "code": "FPK",
      "deviceName": "Tubing, Fluid Delivery",
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      "latest": "2003-07-11",
      "medianReviewDays": 29
    },
    {
      "code": "JAA",
      "deviceName": "System, X-Ray, Fluoroscopic, Image-Intensified",
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      "latest": "1992-10-09",
      "medianReviewDays": 68
    },
    {
      "code": "JAK",
      "deviceName": "System, X-Ray, Tomography, Computed",
      "clearances": 2,
      "latest": "2008-10-17",
      "medianReviewDays": 49
    },
    {
      "code": "DRE",
      "deviceName": "Dilator, Vessel, For Percutaneous Catheterization",
      "clearances": 1,
      "latest": "1983-05-09",
      "medianReviewDays": 27
    },
    {
      "code": "DWE",
      "deviceName": "Tubing, Pump, Cardiopulmonary Bypass",
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      "latest": "1981-04-17",
      "medianReviewDays": 11
    },
    {
      "code": "EAG",
      "deviceName": "Cephalometer",
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      "latest": "1987-02-24",
      "medianReviewDays": 34
    },
    {
      "code": "FOX",
      "deviceName": "Stand, Infusion",
      "clearances": 1,
      "latest": "1997-02-25",
      "medianReviewDays": 90
    },
    {
      "code": "GDM",
      "deviceName": "Needle, Aspiration And Injection, Reusable",
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      "latest": "1987-12-30",
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    },
    {
      "code": "IXO",
      "deviceName": "Synchronizer, Ecg / Respirator, Radiographic",
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      "medianReviewDays": 100
    },
    {
      "code": "IZP",
      "deviceName": "Programmer, Changer, Film/Cassette, Radiographic",
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      "latest": "1988-02-11",
      "medianReviewDays": 106
    },
    {
      "code": "IZQ",
      "deviceName": "Injector, Contrast Medium, Automatic",
      "clearances": 1,
      "latest": "2007-03-27",
      "medianReviewDays": 168
    },
    {
      "code": "KPR",
      "deviceName": "System, X-Ray, Stationary",
      "clearances": 1,
      "latest": "1988-11-04",
      "medianReviewDays": 56
    },
    {
      "code": "QEW",
      "deviceName": "Peripheral Mechanical Thrombectomy With Aspiration",
      "clearances": 1,
      "latest": "2013-07-29",
      "medianReviewDays": 165
    }
  ],
  "productCodesShown": 23,
  "productCodesTotal": "23",
  "recentClearances": [
    {
      "kNumber": "K133023",
      "deviceName": "JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6",
      "productCode": "MCW",
      "decisionDate": "2014-08-27",
      "reviewDays": 335
    },
    {
      "kNumber": "K130381",
      "deviceName": "ANGIOJET ULTRA POWER PULSE KIT",
      "productCode": "QEW",
      "decisionDate": "2013-07-29",
      "reviewDays": 165
    },
    {
      "kNumber": "K130637",
      "deviceName": "JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM",
      "productCode": "MCW",
      "decisionDate": "2013-04-10",
      "reviewDays": 30
    },
    {
      "kNumber": "K122916",
      "deviceName": "JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM",
      "productCode": "MCW",
      "decisionDate": "2012-10-19",
      "reviewDays": 28
    },
    {
      "kNumber": "K113363",
      "deviceName": "ANGIOJET SOLENT DISTA THROMBECTOMY SET",
      "productCode": "QEZ",
      "decisionDate": "2012-06-06",
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    },
    {
      "kNumber": "K113133",
      "deviceName": "MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE",
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      "decisionDate": "2011-12-15",
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    },
    {
      "kNumber": "K113428",
      "deviceName": "ANGIOJET ULTRA DVX THROMBECTOMY SET",
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      "decisionDate": "2011-12-02",
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    },
    {
      "kNumber": "K112086",
      "deviceName": "MEDRAD MARK 7 ARTERION  (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE",
      "productCode": "DXT",
      "decisionDate": "2011-10-14",
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    },
    {
      "kNumber": "K111182",
      "deviceName": "ANGIOJET SOLENT OMNI THROMBECTOMY SET",
      "productCode": "QEZ",
      "decisionDate": "2011-05-24",
      "reviewDays": 27
    },
    {
      "kNumber": "K100798",
      "deviceName": "MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C",
      "productCode": "FRN",
      "decisionDate": "2010-06-23",
      "reviewDays": 93
    }
  ],
  "nameVariants": {
    "total": "5",
    "shown": [
      {
        "name": "Medrad Inc",
        "dataset": "device/enforcement",
        "method": "normalised"
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      {
        "name": "Medrad Inc",
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      {
        "name": "Medrad Inc dba Bayer R&I",
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      },
      {
        "name": "Medrad Inc dba Bayer R&I",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Medrad, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Medrad%20Inc%20dba%20Bayer%20R%26I%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Medrad%20Inc%20dba%20Bayer%20R%26I%22"
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  "retrievedAt": "2026-08-11T14:48:53.042Z"
}