{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Gebauer Co. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/gebauer-co (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/gebauer-co",
    "json_url": "https://devicerts.com/manufacturers/gebauer-co.json",
    "markdown_url": "https://devicerts.com/manufacturers/gebauer-co.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/gebauer-co",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Gebauer Co.",
    "url": "https://devicerts.com/manufacturers/gebauer-co",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "GEBAUER COMPANY"
    ],
    "country": "United States",
    "country_basis": "from the FDA registration address",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "FDA"
    ],
    "identifiers": [
      {
        "label": "FDA FEI",
        "value": "1519179"
      }
    ],
    "summary": "Gebauer Co. is a medical device manufacturer, with 23 devices listed in FDA GUDID and FDA 510(k) (FDA Unclassified) and 9 FDA recalls as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 23,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 9,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 12
      },
      {
        "registry": "FDA 510(k)",
        "devices": 11
      }
    ],
    "device_classes": [
      {
        "class": "FDA Unclassified",
        "devices": 23
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 23,
    "total": 23,
    "all_devices_url": "https://devicerts.com/manufacturers/gebauer-co",
    "items": [
      {
        "name": "Gebauer's Pain Ease One 0386-0008-05",
        "url": "https://devicerts.com/devices/gebauers-pain-ease-one-0386-0008-05",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)",
        "url": "https://devicerts.com/devices/gebauers-pain-ease-topical-anesthetic-skin-refrigerant-mist-mly-k260870",
        "model_reference": "K260870",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-08-27",
        "open_recall": false
      },
      {
        "name": "Gebauer's Ethyl Chloride Fine Spray Accu-Stream 360 0386-0001-13",
        "url": "https://devicerts.com/devices/gebauers-ethyl-chloride-fine-spray-accu-stream-360-0386-0001-13",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Pain Ease Medium Stream 0386-0008-03",
        "url": "https://devicerts.com/devices/gebauers-pain-ease-medium-stream-0386-0008-03",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Pain Ease Mist Spray 0386-0008-02",
        "url": "https://devicerts.com/devices/gebauers-pain-ease-mist-spray-0386-0008-02",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Ethyl Chloride Fine Spray 0386-0001-04",
        "url": "https://devicerts.com/devices/gebauers-ethyl-chloride-fine-spray-0386-0001-04",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Spray and Stretch 0386-0004-04",
        "url": "https://devicerts.com/devices/gebauers-spray-and-stretch-0386-0004-04",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Ethyl Chloride Medium Spray Accu-Stream 360 0386-0001-11",
        "url": "https://devicerts.com/devices/gebauers-ethyl-chloride-medium-spray-accu-stream-360-0386-0001-11",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Ethyl Chloride Mist Spray 0386-0001-02",
        "url": "https://devicerts.com/devices/gebauers-ethyl-chloride-mist-spray-0386-0001-02",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Instant Ice 0386-0010-01",
        "url": "https://devicerts.com/devices/gebauers-instant-ice-0386-0010-01",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Pain Ease Mist Spray 0386-0008-01",
        "url": "https://devicerts.com/devices/gebauers-pain-ease-mist-spray-0386-0008-01",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Pain Ease Medium Stream 0386-0008-04",
        "url": "https://devicerts.com/devices/gebauers-pain-ease-medium-stream-0386-0008-04",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gebauer's Ethyl Chloride Medium Spray 0386-0001-03",
        "url": "https://devicerts.com/devices/gebauers-ethyl-chloride-medium-spray-0386-0001-03",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25",
        "url": "https://devicerts.com/devices/salivart-oral-moisturizer-model-number-03866-009-75-salivart-lfd",
        "model_reference": "K981693",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-08-06",
        "open_recall": false
      },
      {
        "name": "Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07",
        "url": "https://devicerts.com/devices/gebauers-skin-refrigerant-mist-stream-gebauers-skin-refriger-mly",
        "model_reference": "K032671",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2004-03-17",
        "open_recall": false
      },
      {
        "name": "Gebauer's Chloride Fine Nozze",
        "url": "https://devicerts.com/devices/gebauers-chloride-fine-nozze-mly",
        "model_reference": "K991514",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1999-07-16",
        "open_recall": false
      },
      {
        "name": "Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)",
        "url": "https://devicerts.com/devices/gebauers-pain-ease-topical-anesthetic-skin-refrigerant-mist-mly",
        "model_reference": "K172028",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2017-10-27",
        "open_recall": false
      },
      {
        "name": "Fluori Methane Ss- A Vapocoolant/Skin Ref. Device",
        "url": "https://devicerts.com/devices/fluori-methane-ss-a-vapocoolant-skin-ref-device-mly",
        "model_reference": "K930915",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1994-09-29",
        "open_recall": false
      },
      {
        "name": "Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray",
        "url": "https://devicerts.com/devices/ethyl-chloride-medium-jet-stream-ethyl-chloride-fine-pinpoin-mly",
        "model_reference": "K190161",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2019-05-07",
        "open_recall": false
      },
      {
        "name": "Gebauer's Fluori-Methane, Model 0386-0003-04",
        "url": "https://devicerts.com/devices/gebauers-fluori-methane-model-0386-0003-04-mly",
        "model_reference": "K001624",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-01-25",
        "open_recall": false
      },
      {
        "name": "Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray), Model P/N-03",
        "url": "https://devicerts.com/devices/gebauers-skin-refrigerant-mist-spray-model-p-n-0386-0010-07-mly",
        "model_reference": "K031036",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2003-07-10",
        "open_recall": false
      },
      {
        "name": "Gebauer's Fluro Ethyl, Model 0386-0002-09",
        "url": "https://devicerts.com/devices/gebauers-fluro-ethyl-model-0386-0002-09-mly",
        "model_reference": "K002596",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-02-15",
        "open_recall": false
      },
      {
        "name": "Gebauer's Instant Ice",
        "url": "https://devicerts.com/devices/gebauers-instant-ice-mly",
        "model_reference": "K021726",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2002-12-12",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0218-2009",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2008-09-03",
      "product_code": "MLY",
      "reason": "Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator.  The product can also leak coolant from the side of the valve onto the fingers of the user."
    },
    {
      "number": "Z-1057-2007",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2007-04-17",
      "product_code": "MLY",
      "reason": "Mold contamination"
    },
    {
      "number": "Z-1058-2007",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2007-04-17",
      "product_code": "MLY",
      "reason": "Mold contamination"
    },
    {
      "number": "Z-1059-2007",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2007-04-17",
      "product_code": "MLY",
      "reason": "Mold contamination"
    },
    {
      "number": "Z-1060-2007",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2007-04-17",
      "product_code": "MLY",
      "reason": "Mold contamination"
    },
    {
      "number": "Z-1061-2007",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2007-04-17",
      "product_code": "MLY",
      "reason": "Mold contamination"
    },
    {
      "number": "Z-1062-2007",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2007-04-17",
      "product_code": "MLY",
      "reason": "Mold contamination"
    },
    {
      "number": "Z-0497-2007",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2007-01-19",
      "product_code": "LFD",
      "reason": "Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing."
    },
    {
      "number": "Z-0641-04",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2004-02-23",
      "product_code": "LFD",
      "reason": "The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty."
    }
  ]
}