Xltek
CanadaFDA applicant, unverified
Xltek is a medical device manufacturer, with 162 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 162
Registry facts
- Registries
- FDA GUDID 159
- FDA 510(k) 3
- Device classes
- FDA Class II 159
- FDA Class I 1
- Identifiers
- DUNS 245258280
What Xltek makes
Xltek manufactures diagnostic devices for neurological and auditory assessments, including electroencephalographs (EEGs), electromyographs (EMGs), and polysomnographs for sleep studies. Their portfolio also includes ophthalmic fundus cameras for retinal imaging, auditory stimulators for hearing tests, and disposable scalp and cutaneous electrodes for signal recording. Battery chargers for noninvasive devices are also part of their product line.
The company’s devices are regulated under FDA classifications, with most falling into Class I or Class II categories. Products are authorised via 510(k) clearances and listed under the FDA’s Unique Device Identification (UDI) system.
Catalogue
Search and filter all 162 devicesShowing 1-50 of 162
Company details
- DUNS number
- 245258280
- OTS@natus.com
- Phone
- 905-829-5300
Frequently asked questions
How many devices does XLTEK have in the registry?
The registry currently lists 162 devices for XLTEK. Devices recorded under merged duplicate company entries are counted once.
Which registries list XLTEK's devices?
Among its 50 most recently registered devices, XLTEK has devices listed in FDA GUDID (50 devices).
What risk classes do XLTEK's devices fall under?
Among its 50 most recently registered devices, the classes recorded for XLTEK's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from XLTEK in the registry?
The most recently registered devices listed for XLTEK include Natus 046795-W, Natus 046798-W, Natus 046799-W and Natus 046796-W.