{
  "companyId": "56382",
  "slug": "ohmeda-medical-56382",
  "name": "Ohmeda Medical",
  "clearances": {
    "total": 123,
    "last12Months": 0,
    "first": "1984-10-04",
    "latest": "2016-03-17"
  },
  "medianReviewDays": 79,
  "productCodeCount": 39,
  "recalls": {
    "total": 15,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-0041-2020",
        "productCode": "FMZ",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2018-10-05",
        "reason": "GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source of infection. Upon review, the Agency concluded that the cleaning and care guidelines provided by the firm were inadequate for effective cleaning of the device. In particular, the instructions do not instruct for removal of canopy seal prior to cleaning, which leads to the buildup of debris."
      },
      {
        "resNumber": "Z-1181-2018",
        "productCode": "FOX",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2017-12-01",
        "reason": "There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator."
      },
      {
        "resNumber": "Z-1501-2017",
        "productCode": "KZF",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2016-11-18",
        "reason": "Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury."
      },
      {
        "resNumber": "Z-1502-2017",
        "productCode": "FMZ",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2016-11-18",
        "reason": "Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury."
      },
      {
        "resNumber": "Z-1503-2017",
        "productCode": "LBI",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2016-11-18",
        "reason": "Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury."
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "BSZ",
      "deviceName": "Gas-Machine, Anesthesia",
      "clearances": 17,
      "latest": "1998-04-21",
      "medianReviewDays": 132
    },
    {
      "code": "FMZ",
      "deviceName": "Incubator, Neonatal",
      "clearances": 17,
      "latest": "2016-03-17",
      "medianReviewDays": 79
    },
    {
      "code": "FMT",
      "deviceName": "Warmer, Infant Radiant",
      "clearances": 12,
      "latest": "2013-02-05",
      "medianReviewDays": 56
    },
    {
      "code": "CBK",
      "deviceName": "Ventilator, Continuous, Facility Use",
      "clearances": 10,
      "latest": "1996-09-27",
      "medianReviewDays": 91
    },
    {
      "code": "CCK",
      "deviceName": "Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase",
      "clearances": 6,
      "latest": "1995-07-07",
      "medianReviewDays": 137
    },
    {
      "code": "DQA",
      "deviceName": "Oximeter",
      "clearances": 5,
      "latest": "1996-10-10",
      "medianReviewDays": 129
    },
    {
      "code": "BZK",
      "deviceName": "Spirometer, Monitoring (W/Wo Alarm)",
      "clearances": 4,
      "latest": "1986-09-12",
      "medianReviewDays": 7
    },
    {
      "code": "CBQ",
      "deviceName": "Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)",
      "clearances": 4,
      "latest": "1997-01-17",
      "medianReviewDays": 73
    },
    {
      "code": "FMG",
      "deviceName": "Stopcock, I.V. Set",
      "clearances": 4,
      "latest": "1998-01-13",
      "medianReviewDays": 77
    },
    {
      "code": "CAD",
      "deviceName": "Vaporizer, Anesthesia, Non-Heated",
      "clearances": 3,
      "latest": "1995-03-30",
      "medianReviewDays": 332
    },
    {
      "code": "DXN",
      "deviceName": "System, Measurement, Blood-Pressure, Non-Invasive",
      "clearances": 3,
      "latest": "1994-08-01",
      "medianReviewDays": 238
    },
    {
      "code": "FOZ",
      "deviceName": "Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days",
      "clearances": 3,
      "latest": "1994-10-14",
      "medianReviewDays": 121
    },
    {
      "code": "LBI",
      "deviceName": "Unit, Neonatal Phototherapy",
      "clearances": 3,
      "latest": "2001-07-19",
      "medianReviewDays": 108
    },
    {
      "code": "BSF",
      "deviceName": "Absorber, Carbon-Dioxide",
      "clearances": 2,
      "latest": "1985-07-15",
      "medianReviewDays": 53
    },
    {
      "code": "BTL",
      "deviceName": "Ventilator, Emergency, Powered (Resuscitator)",
      "clearances": 2,
      "latest": "2007-04-20",
      "medianReviewDays": 88
    },
    {
      "code": "BTM",
      "deviceName": "Ventilator, Emergency, Manual (Resuscitator)",
      "clearances": 2,
      "latest": "2007-04-20",
      "medianReviewDays": 85
    },
    {
      "code": "BYE",
      "deviceName": "Attachment, Breathing, Positive End Expiratory Pressure",
      "clearances": 2,
      "latest": "1988-04-29",
      "medianReviewDays": 17
    },
    {
      "code": "CCL",
      "deviceName": "Analyzer, Gas, Oxygen, Gaseous-Phase",
      "clearances": 2,
      "latest": "1988-08-24",
      "medianReviewDays": 8
    },
    {
      "code": "BTI",
      "deviceName": "Compressor, Air, Portable",
      "clearances": 1,
      "latest": "1985-11-01",
      "medianReviewDays": 7
    },
    {
      "code": "BTR",
      "deviceName": "Tube, Tracheal (W/Wo Connector)",
      "clearances": 1,
      "latest": "1984-10-19",
      "medianReviewDays": 25
    },
    {
      "code": "BZA",
      "deviceName": "Connector, Airway (Extension)",
      "clearances": 1,
      "latest": "1985-02-12",
      "medianReviewDays": 75
    },
    {
      "code": "BZR",
      "deviceName": "Mixer, Breathing Gases, Anesthesia Inhalation",
      "clearances": 1,
      "latest": "1985-10-16",
      "medianReviewDays": 26
    },
    {
      "code": "CAP",
      "deviceName": "Monitor, Airway Pressure (Includes Gauge And/Or Alarm)",
      "clearances": 1,
      "latest": "1987-01-12",
      "medianReviewDays": 56
    },
    {
      "code": "CAX",
      "deviceName": "Flowmeter, Tube, Thorpe, Back-Pressure Compensated",
      "clearances": 1,
      "latest": "1991-04-12",
      "medianReviewDays": 78
    },
    {
      "code": "CCE",
      "deviceName": "Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling",
      "clearances": 1,
      "latest": "1988-03-04",
      "medianReviewDays": 73
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "39",
  "recentClearances": [
    {
      "kNumber": "K152814",
      "deviceName": "Giraffe OmniBed Carestation CS1",
      "productCode": "FMZ",
      "decisionDate": "2016-03-17",
      "reviewDays": 171
    },
    {
      "kNumber": "K152809",
      "deviceName": "Giraffe Incubator Carestation CS1",
      "productCode": "FMZ",
      "decisionDate": "2015-12-31",
      "reviewDays": 94
    },
    {
      "kNumber": "K123309",
      "deviceName": "GIRAFFE AND PANDA WARMERS",
      "productCode": "FMT",
      "decisionDate": "2013-02-05",
      "reviewDays": 104
    },
    {
      "kNumber": "K122267",
      "deviceName": "GIRAFFE AND PANDA WARMERS",
      "productCode": "FMT",
      "decisionDate": "2012-10-02",
      "reviewDays": 64
    },
    {
      "kNumber": "K101804",
      "deviceName": "GIRAFFE AND PANDA WARMERS",
      "productCode": "FMT",
      "decisionDate": "2010-07-21",
      "reviewDays": 23
    },
    {
      "kNumber": "K101788",
      "deviceName": "GIRAFFE OMNIBED",
      "productCode": "FMZ",
      "decisionDate": "2010-07-21",
      "reviewDays": 26
    },
    {
      "kNumber": "K101778",
      "deviceName": "GIRAFFE INCUBATOR",
      "productCode": "FMZ",
      "decisionDate": "2010-07-21",
      "reviewDays": 26
    },
    {
      "kNumber": "K090697",
      "deviceName": "MODIFICATION TO: GIRAFFE AND PANDA WARMER",
      "productCode": "FMT",
      "decisionDate": "2009-04-16",
      "reviewDays": 30
    },
    {
      "kNumber": "K072157",
      "deviceName": "MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)",
      "productCode": "FMT",
      "decisionDate": "2007-08-27",
      "reviewDays": 24
    },
    {
      "kNumber": "K070377",
      "deviceName": "GIRAFFE AND PANDA WARMER",
      "productCode": "FMT",
      "decisionDate": "2007-07-11",
      "reviewDays": 153
    }
  ],
  "nameVariants": {
    "total": "6",
    "shown": [
      {
        "name": "Ohmeda Medical",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Ohmeda Medical",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Ohmeda Medical",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Ohmeda Medical, A Division of Datex-Ohmeda, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Ohmeda Medical, A division of Datex-Ohmeda, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Ohmeda%20Medical%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Ohmeda%20Medical%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": "2026-08-11T14:48:53.037Z"
}