Data / Medical devices / Canada / Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek)
Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek): FDA-registered device maker in OAKVILLE Ontario, Canada, 32 510(k) clearances
Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek) is registered with the FDA (registration 9612330) in OAKVILLE Ontario, Canada. It lists 20 device types. The FDA files 32 510(k) clearances under its listings, the newest dated November 19, 2024. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612330
- FEI number
- 3002809369
- Address
- 2568 Bristol Cir., OAKVILLE Ontario, Canada, L6H 5S1
- Owner or operator
- Natus Medical Incorporated (9004873)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 19, 2007
- Registered through
- 2026
- Brand names listed
- 128 Channel EEG Headbox, Background Pattern Classification, Brain Monitor with Neonatal Sensor, Brainwatch with headbnd, Breath Sensors, CFM Olympic Brainz Monitor, Cable Electrodes, EEG32 EEG32U PK1188 10399 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplitude-Integrated Electroencephalograph | OMA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Automatic Event Detection Software For Full-Montage Electroencephalograph | OMB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Burst Suppression Detection Software For Electroencephalograph | ORT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Specification developer | accessdata.fda.gov |
| Electrode, Cortical | GYC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electromyograph, Diagnostic | IKN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Source Localization Software For Electroencephalograph Or Magnetoencephalograph | OLX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Electrical, Evoked Response | GWF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Photic, Evoked Response | GWE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2024 | K242930 | Natus BrainWatch System | OMC | Substantially Equivalent | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| May 18, 2020 | K200878 | Natus NeuroWorks | OMB | Substantially Equivalent | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| September 27, 2019 | K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant | MNR | Substantially Equivalent | Embla Systems | accessdata.fda.gov |
| March 1, 2019 | K173793 | XactTrace Single Use Respiratory Effort Belt System | MNR | Substantially Equivalent | Embla Systems | accessdata.fda.gov |
| June 15, 2018 | K173936 | Natus Photic Stimulator | GWE | Substantially Equivalent | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| June 14, 2018 | K180290 | Natus Brain Monitor Amplifier | GWQ | Substantially Equivalent | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| March 14, 2018 | K180421 | Natus NeuroWorks | OMB | Substantially Equivalent | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| February 22, 2018 | K180181 | Natus Quantum | GWQ | Substantially Equivalent | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) | accessdata.fda.gov |
| November 13, 2017 | K172703 | Disposable Snap Electrode | GXY | Substantially Equivalent | Embla Systems | accessdata.fda.gov |
| December 14, 2016 | K163163 | XLTEK EMU40EX EEG Headbox | GWQ | Substantially Equivalent | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| November 4, 2016 | K162595 | Trex_HD | GWQ | Substantially Equivalent | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| June 3, 2016 | K152301 | Background Pattern Classification [BPc(TM)] | OMA | Substantially Equivalent | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| April 20, 2015 | K143440 | Natus Quantum | GWQ | Substantially Equivalent | Natus Medical Incorporated | accessdata.fda.gov |
| February 14, 2014 | K131266 | TREZ_HD | GWQ | Substantially Equivalent | Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| May 8, 2013 | K123079 | OLYMPIC BRAINZ MONITOR | OMA | Substantially Equivalent | Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| February 21, 2013 | K122516 | EMBLETTA MPR | MNR | Substantially Equivalent | Embla Systems | accessdata.fda.gov |
| June 29, 2012 | K120260 | ICTA | OMB | Substantially Equivalent | Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| April 19, 2011 | K090277 | NATUS SLEEPWORKS, MODEL 104017 | OLZ | Substantially Equivalent | Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| December 3, 2010 | K100126 | STELLATE GRIDVIEW | OLX | Substantially Equivalent | Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| August 11, 2010 | K093304 | PROTEKTOR 32 | GWF | Substantially Equivalent | Natus Medical, Inc. | accessdata.fda.gov |
| June 16, 2010 | K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | OMA | Substantially Equivalent | Natus Medical, Inc. | accessdata.fda.gov |
| February 22, 2010 | K090019 | NATUS NEUROWORKS, MODEL 104196 | OMB | Substantially Equivalent | Natus Medical, Inc. | accessdata.fda.gov |
| April 21, 2006 | K053386 | XLTEK EMU40 EEG HEADBOX, MODEL PK1072 | GWQ | Substantially Equivalent | Excel Tech. , Ltd. | accessdata.fda.gov |
| December 21, 2004 | K043132 | UNIVERSAL XACTTRACE | MNR | Substantially Equivalent | Medcare Flaga | accessdata.fda.gov |
| September 16, 2004 | K042223 | XLTEK CONNEX IP HEADBOX, MODEL 1054 | OMB | Substantially Equivalent | Excel Tech. , Ltd. | accessdata.fda.gov |
| March 12, 2004 | K040360 | EMU128S, MODEL EX-NW-128S | GWQ | Substantially Equivalent | Excel Tech. , Ltd. | accessdata.fda.gov |
| October 10, 2003 | K033010 | BRM2 BRAIN MONITOR | OLT | Substantially Equivalent | Brainz Instruments , Ltd. | accessdata.fda.gov |
| October 1, 2001 | K011794 | XLTEK LED GOGGLES, MODEL LED-01 | GWE | Substantially Equivalent | Excel Tech. , Ltd. | accessdata.fda.gov |
| October 6, 2000 | K002332 | EEG SPIKE AND EVENT DETECTOR MODULE | OMB | Substantially Equivalent | Excel Tech. , Ltd. | accessdata.fda.gov |
| August 4, 1999 | K991903 | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) | GWE | Substantially Equivalent | Excel Tech. , Ltd. | accessdata.fda.gov |
| April 21, 1998 | K980214 | EXCEL NEURO WORKS | GWQ | Substantially Equivalent | Excel Tech. , Ltd. | accessdata.fda.gov |
| November 7, 1995 | K941144 | EXCEL EMG | IKN | Substantially Equivalent | Excel Tech. , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 29, 2026 | 99941 | Not yet classified | Open, Classified | Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011 | The device may be unable to correctly format its internal memory. When the internal memory cannot be correctly formatted, previously recorded studies may remain on the device and may be updated with incorrect patient information from a subsequent study. The issue may also prevent studies from initiating recording successfully or may cause recordings to end p | accessdata.fda.gov |
| June 18, 2025 | 97091 | Class II | Ongoing | Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph | Natus received two complaints of left side labeling show impedance for right side. | accessdata.fda.gov |
| May 7, 2025 | 96761 | Class II | Ongoing | Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: | Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device. | accessdata.fda.gov |
| December 2, 2021 | 89425 | Class II | Terminated | IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software | Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user. | accessdata.fda.gov |
| March 5, 2020 | 85189 | Class II | Terminated | natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph | The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the affected items. | accessdata.fda.gov |
| May 18, 2018 | 80265 | Class II | Terminated | Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record docume | Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail. | accessdata.fda.gov |
| May 15, 2018 | 80239 | Class II | Terminated | XLTEK EMU40EX EEG Headbox | Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting. | accessdata.fda.gov |
| November 11, 2015 | 72763 | Class II | Terminated | Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological si | During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity. | accessdata.fda.gov |
| January 2, 2015 | 70157 | Class II | Terminated | EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provid | Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege. | accessdata.fda.gov |
Compare with other makers
- All makers of Amplitude-Integrated Electroencephalograph
- All makers of Automatic Event Detection Software For Full-Montage Electroencephalograph
- All makers of Reduced- Montage Standard Electroencephalograph
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Stimulator, Photic, Evoked Response
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
Updated October 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.