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X-Nav Technologies, LLC

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000003234

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.

Devices
172
Registrations
EUDAMED
FDA recalls
43 ongoing

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 142
  • EUDAMED 27
  • FDA 510(k) 6

A device listed in two registries counts in both.

Device classes
  • FDA Class II 145
  • EU Class IIa 25
  • EU Class I 2
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000003234

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA recalls
Authorised rep.
Emergo Europe B.V.NL

What X-Nav Technologies, LLC makes

X-Nav Technologies, LLC produces surgical navigation systems for dental and craniofacial procedures, including the X-Guide platform for real-time 3D guidance during interventions. Their portfolio also includes non-bioabsorbable craniofacial bone screws and CAD/CAM dental milling systems for laboratory use, alongside specialized dental treatment software applications.

The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIa, with listings in the FDA’s 510(k) and UDI databases, as well as in the EU’s eudamed registry. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue172

Newest first, rows 1-50 of 172

Search and filter all 172 devices
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  • X-Guide P011265

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011266

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011268

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011271

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011272

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011269

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011693

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011694

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011696

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011697

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P012126

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P012127

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P012128

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P012129

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011548

    Listed Registry: GUDID Class:II

  • X-Guide P011558

    Listed Registry: GUDID Class:II

  • X-Guide P012361

    Listed Registry: GUDID Class:II

  • X-Guide P011543

    Listed Registry: GUDID Class:II

  • X-Guide P011545

    Listed Registry: GUDID Class:II

  • X-Guide P011544

    Listed Registry: GUDID Class:II

  • X-Guide P011546

    Listed Registry: GUDID Class:II

  • X-Guide P012185

    Listed Registry: GUDID Class:II

  • X-Guide P011281

    Listed Registry: GUDID Class:II

  • X-Guide P012184

    Listed Registry: GUDID Class:II

  • X-Guide P011707

    Listed Registry: GUDID Class:II

  • X-Guide Surgical Navigation System Ref K253954

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • X-Guide System Ref P011000

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • X-Guide P010701

    Listed Registry: GUDID Class:II

  • X-Guide P007738

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010870

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010818

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010869

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010722

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P009311

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010817

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P011211

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P009154

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010875

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010308

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P007839

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010874

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010227

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010876

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P008818

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P010873

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P008930

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P009081

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P008542 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P008542

    Active Regimes: 510(k) Registry: GUDID Class:II

  • X-Guide P008800

    Active Regimes: 510(k) Registry: GUDID Class:II

Rows 1-50 of 172

Showing 1-50 of 172

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000003234
EUDAMED status
Active since 2023
EUDAMED registered name
X-Nav Technologies, LLC
EUDAMED abbreviated name
X-Nav
Registered address
1555, Bustard Rd, 19446, Lansdale, United States
Website
x-navtech.com
Phone
+18554759628(from company website)
PRRC contact
Kimberly Chan(public in EUDAMED)

FDA recalls4

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 4 recalls initiated by X-Nav Technologies, LLC, the earliest on 2016-02-23 and the most recent on 2024-03-04. By recorded status: 3 ongoing and 1 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 0
  • 2024 2
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2024

    • 4 Mar 2024 Z-1392-2024 Class II Ongoing 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. Distribution: Worldwide distribution - US Nationwide and the countries of China, Europe, Japan. Submission number: K232148
    • 4 Mar 2024 Z-1393-2024 Class II Ongoing 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. Distribution: Worldwide distribution - US Nationwide and the countries of China, Europe, Japan. Submission number: K232148

  • 2022

    • 28 Sep 2022 Z-0222-2023 Class II Ongoing 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. Distribution: US Nationwide distribution and Foreign country of: Canada Submission number: K211701

  • 2016

    • 23 Feb 2016 Z-1391-2016 Class II Terminated 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 Distribution: US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC. Submission number: K150222

From the company website

Read 18 Sep 2026

X-Nav Knows Dental. X-Nav Knows Technology. We innovate to deliver solutions that we believe will help you practice better dentistry. X-Guide surgical navigation boasts dynamic 3D navigation.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does X-Nav Technologies, LLC have in the registry?

The registry currently lists 172 devices for X-Nav Technologies, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list X-Nav Technologies, LLC's devices?

Among its 50 most recently registered devices, X-Nav Technologies, LLC has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do X-Nav Technologies, LLC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for X-Nav Technologies, LLC's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for X-Nav Technologies, LLC?

FDA recall records list 4 recalls initiated by X-Nav Technologies, LLC, the most recent initiated on 4 Mar 2024. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from X-Nav Technologies, LLC in the registry?

The most recently registered devices listed for X-Nav Technologies, LLC include X-Guide P011265, X-Guide P011266, X-Guide P011268 and X-Guide P011271.

Generated automatically from registry data and not verified by a human reviewer.