{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Axonics Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/axonics-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/axonics-inc",
    "json_url": "https://devicerts.com/manufacturers/axonics-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/axonics-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "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/axonics-inc",
    "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": "Axonics Inc.",
    "url": "https://devicerts.com/manufacturers/axonics-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000008413"
      }
    ],
    "summary": "Axonics Inc. is a medical device manufacturer based in the United States, with 29 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU AIMDD; FDA Class II and I) and 1 FDA recall as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 29,
    "devices_note": null,
    "certificates": 2,
    "fda_recalls_matched_by_name": 1,
    "fda_recalls_ongoing": 1,
    "fda_recalls_ongoing_recent": 1,
    "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": "EUDAMED",
        "devices": 24
      },
      {
        "registry": "FDA GUDID",
        "devices": 22
      },
      {
        "registry": "FDA 510(k)",
        "devices": 5
      }
    ],
    "device_classes": [
      {
        "class": "EU AIMDD",
        "devices": 24
      },
      {
        "class": "FDA Class II",
        "devices": 4
      },
      {
        "class": "FDA Class I",
        "devices": 1
      }
    ],
    "top_emdn_categories": [
      {
        "code": "J02",
        "name": "Implantable neurostimulators",
        "url": "https://devicerts.com/categories/emdn/J02",
        "devices": 24
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Emergo Europe B.V.",
        "url": "https://devicerts.com/representatives/emergo-europe-bv-nl-ar-000000116",
        "country": "Netherlands"
      }
    ]
  },
  "devices": {
    "shown": 29,
    "total": 29,
    "all_devices_url": "https://devicerts.com/manufacturers/axonics-inc",
    "items": [
      {
        "name": "Total Ige-Fast Test",
        "url": "https://devicerts.com/devices/total-ige-fast-test-dgc",
        "model_reference": "K823494",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1983-01-14",
        "open_recall": false
      },
      {
        "name": "Axonics Lead Implant Kit",
        "url": "https://devicerts.com/devices/axonics-lead-implant-kit-1801",
        "model_reference": "1801",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics PNE Lead Implant Kit",
        "url": "https://devicerts.com/devices/axonics-pne-lead-implant-kit-1701",
        "model_reference": "1701",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, Lead Extension Cable",
        "url": "https://devicerts.com/devices/axonics-accessory-lead-extension-cable-9009",
        "model_reference": "9009",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, Stimulation Ground Cable",
        "url": "https://devicerts.com/devices/axonics-accessory-stimulation-ground-cable-9003",
        "model_reference": "9003",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics PNE Lead",
        "url": "https://devicerts.com/devices/axonics-pne-lead-1901",
        "model_reference": "1901",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Audit",
        "url": "https://devicerts.com/devices/audit-ewo",
        "model_reference": "K822335",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1983-02-07",
        "open_recall": false
      },
      {
        "name": "Audit Tm V",
        "url": "https://devicerts.com/devices/audit-tm-v-gwf",
        "model_reference": "K843712",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1985-04-05",
        "open_recall": false
      },
      {
        "name": "Allergenetics Fluoro-Fast Reader",
        "url": "https://devicerts.com/devices/allergenetics-fluoro-fast-reader-jzt",
        "model_reference": "K831870",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1983-08-12",
        "open_recall": false
      },
      {
        "name": "Audit V Ax 135",
        "url": "https://devicerts.com/devices/audit-v-ax-135-gwk",
        "model_reference": "K833298",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1983-12-01",
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, Basic Trial Cable",
        "url": "https://devicerts.com/devices/axonics-accessory-basic-trial-cable-9014",
        "model_reference": "9014",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, Charging Belt - Regular Size",
        "url": "https://devicerts.com/devices/axonics-accessory-charging-belt-regular-size-9008-r",
        "model_reference": "9008-R",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, Lead Stimulation Cable",
        "url": "https://devicerts.com/devices/axonics-accessory-lead-stimulation-cable-9007",
        "model_reference": "9007",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Tined Lead",
        "url": "https://devicerts.com/devices/axonics-tined-lead-1201",
        "model_reference": "1201",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Trial Stimulator",
        "url": "https://devicerts.com/devices/axonics-trial-stimulator-1601",
        "model_reference": "1601",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Charging System",
        "url": "https://devicerts.com/devices/axonics-charging-system-1401",
        "model_reference": "1401",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, Foramen Needle - Long",
        "url": "https://devicerts.com/devices/axonics-accessory-foramen-needle-long-9001-l",
        "model_reference": "9001-L",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Tined Lead (with Percutaneous Extension)",
        "url": "https://devicerts.com/devices/axonics-tined-lead-with-percutaneous-extension-2201",
        "model_reference": "2201",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Remote Control",
        "url": "https://devicerts.com/devices/axonics-remote-control-2301",
        "model_reference": "2301",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, Charging Belt - Extended Size",
        "url": "https://devicerts.com/devices/axonics-accessory-charging-belt-extended-size-9008-e",
        "model_reference": "9008-E",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, Charging System Adhesive Carriers",
        "url": "https://devicerts.com/devices/axonics-accessory-charging-system-adhesive-carriers-9005",
        "model_reference": "9005",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, Foramen Needle - Short",
        "url": "https://devicerts.com/devices/axonics-accessory-foramen-needle-short-9001-s",
        "model_reference": "9001-S",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory Dilator and Sheath",
        "url": "https://devicerts.com/devices/axonics-accessory-dilator-and-sheath-9011",
        "model_reference": "9011",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Neurostimulator",
        "url": "https://devicerts.com/devices/axonics-neurostimulator-1101",
        "model_reference": "1101",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory Tunneling Tool and Directional Guide",
        "url": "https://devicerts.com/devices/axonics-accessory-tunneling-tool-and-directional-guide-9012",
        "model_reference": "9012",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Clinician Programmer (EPG/IPG)",
        "url": "https://devicerts.com/devices/axonics-clinician-programmer-epg-ipg-2501",
        "model_reference": "2501",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory Tunneling Tool",
        "url": "https://devicerts.com/devices/axonics-accessory-tunneling-tool-9010",
        "model_reference": "9010",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, J-Clip Stimulation Cable",
        "url": "https://devicerts.com/devices/axonics-accessory-j-clip-stimulation-cable-9006",
        "model_reference": "9006",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axonics Accessory, Torque Wrench",
        "url": "https://devicerts.com/devices/axonics-accessory-torque-wrench-9004",
        "model_reference": "9004",
        "device_class": "Active implantable (AIMDD)",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "MDR 755438",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "BSI Group The Netherlands B.V.",
      "issued": "2024-12-17",
      "expires": "2029-03-11",
      "status": "amended",
      "no_longer_listed": false
    },
    {
      "number": "MDR 755443",
      "type": "Technical documentation",
      "legislation": "MDR",
      "notified_body": "BSI Group The Netherlands B.V.",
      "issued": "2026-07-13",
      "expires": "2029-03-11",
      "status": "supplemented",
      "no_longer_listed": false
    }
  ],
  "recalls": [
    {
      "number": "Z-0198-2027",
      "classification": "Not yet classified",
      "status": "Ongoing",
      "initiated": "2024-07-15",
      "product_code": "EZW",
      "reason": "Retroactively Reported: 10mL luer lock syringes included in kit may  leak , break or experience  other issues that may pose a risk to users."
    }
  ]
}