{ "format": "devicerts.manufacturer.v1", "cite_as": "X-Nav Technologies, LLC. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/x-nav-technologies-llc (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/manufacturers/x-nav-technologies-llc", "json_url": "https://devicerts.com/manufacturers/x-nav-technologies-llc.json", "markdown_url": "https://devicerts.com/manufacturers/x-nav-technologies-llc.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/x-nav-technologies-llc", "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": "X-Nav Technologies, LLC", "url": "https://devicerts.com/manufacturers/x-nav-technologies-llc", "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-000003234" } ], "summary": "X-Nav Technologies, LLC is a medical device manufacturer based in the United States, with 172 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa and I) and 4 FDA recalls as of 15 Nov 2026.", "noindex": false }, "counts": { "devices": 172, "devices_note": null, "certificates": 0, "fda_recalls_matched_by_name": 4, "fda_recalls_ongoing": 3, "fda_recalls_ongoing_recent": 3, "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": 142 }, { "registry": "EUDAMED", "devices": 27 }, { "registry": "FDA 510(k)", "devices": 6 } ], "device_classes": [ { "class": "FDA Class II", "devices": 145 }, { "class": "EU Class IIa", "devices": 25 }, { "class": "EU Class I", "devices": 2 } ], "top_emdn_categories": [ { "code": "Z12", "name": "Instruments for functional explorations and therapeutic interventions", "url": "https://devicerts.com/categories/emdn/Z12", "devices": 26 }, { "code": "Q01", "name": "Dental devices", "url": "https://devicerts.com/categories/emdn/Q01", "devices": 1 } ] }, "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": 50, "total": 172, "all_devices_url": "https://devicerts.com/manufacturers/x-nav-technologies-llc", "items": [ { "name": "X-Guide P011265", "url": "https://devicerts.com/devices/x-guide-p011265", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011266", "url": "https://devicerts.com/devices/x-guide-p011266", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011268", "url": "https://devicerts.com/devices/x-guide-p011268", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011271", "url": "https://devicerts.com/devices/x-guide-p011271", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011272", "url": "https://devicerts.com/devices/x-guide-p011272", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011269", "url": "https://devicerts.com/devices/x-guide-p011269", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011693", "url": "https://devicerts.com/devices/x-guide-p011693", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011694", "url": "https://devicerts.com/devices/x-guide-p011694", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011696", "url": "https://devicerts.com/devices/x-guide-p011696", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011697", "url": "https://devicerts.com/devices/x-guide-p011697", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P012126", "url": "https://devicerts.com/devices/x-guide-p012126", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P012127", "url": "https://devicerts.com/devices/x-guide-p012127", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P012128", "url": "https://devicerts.com/devices/x-guide-p012128", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P012129", "url": "https://devicerts.com/devices/x-guide-p012129", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011548", "url": "https://devicerts.com/devices/x-guide-p011548", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011558", "url": "https://devicerts.com/devices/x-guide-p011558", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P012361", "url": "https://devicerts.com/devices/x-guide-p012361", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011543", "url": "https://devicerts.com/devices/x-guide-p011543", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011545", "url": "https://devicerts.com/devices/x-guide-p011545", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011544", "url": "https://devicerts.com/devices/x-guide-p011544", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011546", "url": "https://devicerts.com/devices/x-guide-p011546", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P012185", "url": "https://devicerts.com/devices/x-guide-p012185-p008641", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011281", "url": "https://devicerts.com/devices/x-guide-p011281", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P012184", "url": "https://devicerts.com/devices/x-guide-p012184", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011707", "url": "https://devicerts.com/devices/x-guide-p011707-p007640", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide Surgical Navigation System", "url": "https://devicerts.com/devices/x-guide-surgical-navigation-system-qry-k253954", "model_reference": "K253954", "device_class": "Class II", "registries": [ "510(k)" ], "status": "Active", "decision_date": "2026-08-28", "open_recall": false }, { "name": "X-Guide System", "url": "https://devicerts.com/devices/x-guide-system-p011000", "model_reference": "P011000", "device_class": "Class IIa", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010701", "url": "https://devicerts.com/devices/x-guide-p010701", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Listed", "decision_date": null, "open_recall": false }, { "name": "X-Guide P007738", "url": "https://devicerts.com/devices/x-guide-p007738", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010870", "url": "https://devicerts.com/devices/x-guide-p010870-fe64f411", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010818", "url": "https://devicerts.com/devices/x-guide-p010818", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010869", "url": "https://devicerts.com/devices/x-guide-p010869-045d325f", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010722", "url": "https://devicerts.com/devices/x-guide-p010722", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P009311", "url": "https://devicerts.com/devices/x-guide-p009311", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010817", "url": "https://devicerts.com/devices/x-guide-p010817", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P011211", "url": "https://devicerts.com/devices/x-guide-p011211", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P009154", "url": "https://devicerts.com/devices/x-guide-p009154-773df39e", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010875", "url": "https://devicerts.com/devices/x-guide-p010875", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010308", "url": "https://devicerts.com/devices/x-guide-p010308", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P007839", "url": "https://devicerts.com/devices/x-guide-p007839-40dfe544", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010874", "url": "https://devicerts.com/devices/x-guide-p010874-ede07736", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010227", "url": "https://devicerts.com/devices/x-guide-p010227", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010876", "url": "https://devicerts.com/devices/x-guide-p010876", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P008818", "url": "https://devicerts.com/devices/x-guide-p008818", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P010873", "url": "https://devicerts.com/devices/x-guide-p010873-c3b5c5ea", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P008930", "url": "https://devicerts.com/devices/x-guide-p008930", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P009081", "url": "https://devicerts.com/devices/x-guide-p009081", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P008542", "url": "https://devicerts.com/devices/x-guide-p008542-50a23b64", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": true }, { "name": "X-Guide P008542", "url": "https://devicerts.com/devices/x-guide-p008542-c84bcf07", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "X-Guide P008800", "url": "https://devicerts.com/devices/x-guide-p008800", "model_reference": null, "device_class": "Class II", "registries": [ "GUDID" ], "status": "Active", "decision_date": null, "open_recall": false } ] }, "certificates": [], "recalls": [ { "number": "Z-1392-2024", "classification": "Class II", "status": "Ongoing", "initiated": "2024-03-04", "product_code": "QRY", "reason": "The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece." }, { "number": "Z-1393-2024", "classification": "Class II", "status": "Ongoing", "initiated": "2024-03-04", "product_code": "QRY", "reason": "The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece." }, { "number": "Z-0222-2023", "classification": "Class II", "status": "Ongoing", "initiated": "2022-09-28", "product_code": "QRY", "reason": "Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip." }, { "number": "Z-1391-2016", "classification": "Class II", "status": "Terminated", "initiated": "2016-02-23", "product_code": "PLV", "reason": "The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The X-Clip contains three fiducial markers made from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3" } ] }