Data / Medical devices / United States / Natus Neurology Incorporated
Natus Neurology Incorporated: FDA-registered device maker in Middleton, WI, United States, 24 510(k) clearances
Natus Neurology Incorporated is registered with the FDA (registration 3010611950) in Middleton, WI, United States. It lists 32 device types. The FDA files 24 510(k) clearances under its listings, the newest dated January 22, 2025. 15 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010611950
- Address
- 3150 Pleasant View Road, Middleton, WI, United States, 53562
- Owner or operator
- Natus Medical Incorporated (9004873)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 21, 2010
- Registered through
- 2026
- Brand names listed
- 025420 PMIO Patient Bedside Monitor Cable, 025430 AC Power Adapter, 025440 USB-to-RS232 Adapter Cable, 026950 14.4V Li-ion Battery, 8-04-12700, 1073 ICS Chartr EP 200 Insert 2 Ch, US Only, 8-04-12702, 1073 ICS Chartr EP 200 Insert, Bone 2 Ch, US only, 8-04-12703, 1073 ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US only, 8-04-12720, 1073 ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, DS only and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| January 22, 2025 | K243982 | Nicolet EDX | GWF | Substantially Equivalent | Natus Neurology Incorporated | accessdata.fda.gov |
| December 12, 2024 | K243495 | Natus Ultrapro S100 (982A0594) | GWF | Substantially Equivalent | Natus Neurology Incorporated | accessdata.fda.gov |
| December 17, 2019 | K192572 | CNS Envision | OLT | Substantially Equivalent | Moberg Research, Inc. | accessdata.fda.gov |
| July 20, 2018 | K173366 | NicoletOne | OLZ | Substantially Equivalent | Natus Neurology Incorporated | accessdata.fda.gov |
| December 19, 2017 | K172743 | Natus VikingQuest | IKN | Substantially Equivalent | Natus Neurology Incorporated | accessdata.fda.gov |
| May 2, 2013 | K130346 | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION | GWF | Substantially Equivalent | Natus Neurology Incorporated | accessdata.fda.gov |
| April 25, 2012 | K120979 | CAREFUSION NICOLET EDX | GWF | Substantially Equivalent | Carefusion 209, Inc. | accessdata.fda.gov |
| March 15, 2012 | K112052 | CAREFUSION NICOLET EDX | GWF | Substantially Equivalent | Carefusion 209, Inc. | accessdata.fda.gov |
| April 8, 2011 | K103140 | NICOLET WIRELESS EEG | GWL | Substantially Equivalent | Carefusion 209, Inc. | accessdata.fda.gov |
| December 30, 2008 | K072964 | NICOLET CORTICAL STIMULATOR | GYC | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| November 5, 2008 | K080217 | COMPONENT NEUROMONITORING SYSTEM | OMA | Substantially Equivalent | Moberg Research, Inc. | accessdata.fda.gov |
| November 6, 2006 | K061908 | NICOLETONE SYSTEM V32 AMPLIFIER | GWQ | Substantially Equivalent | Viasys Neuro Care | accessdata.fda.gov |
| July 12, 2002 | K021185 | NERVUS MONITOR | OLV | Substantially Equivalent | Taugagreining HF | accessdata.fda.gov |
| April 18, 2002 | K013281 | VERSALAB APM | HGM | Substantially Equivalent | Nicolet Biomedical | accessdata.fda.gov |
| September 6, 2001 | K011818 | STERILE EMG ELECTRODES | IKT | Substantially Equivalent | Nicolet Biomedical, Inc. | accessdata.fda.gov |
| March 9, 2001 | K010521 | NICOLET VERSALAB | JAF | Substantially Equivalent | Nicolet Biomedical | accessdata.fda.gov |
| August 7, 1998 | K982635 | CAREDOP II | JAF | Substantially Equivalent | Nicolet Biomedical | accessdata.fda.gov |
| June 20, 1997 | K965065 | TECA. MILLENNIUM | GWF | Substantially Equivalent | Medelec , Ltd. | accessdata.fda.gov |
| January 27, 1997 | K964280 | DG NERVUS | GWQ | Substantially Equivalent | Medelec , Ltd. | accessdata.fda.gov |
| May 12, 1995 | K944196 | IMWXDOP IR | JAF | Substantially Equivalent | Imex Medical Systems, Inc. | accessdata.fda.gov |
| August 23, 1994 | K942441 | IMEXDOP CT+ | JAF | Substantially Equivalent | Imex Medical Systems, Inc. | accessdata.fda.gov |
| June 24, 1991 | K910462 | POCKET DOP 3 | HEP | Substantially Equivalent | Imex Medical Systems, Inc. | accessdata.fda.gov |
| April 11, 1985 | K850259 | ELECTROENCEPHALOGRAPH EEG | GWQ | Substantially Equivalent | Nicolet Biomedical Instruments | accessdata.fda.gov |
| April 11, 1985 | K850108 | EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG | GXY | Substantially Equivalent | Nicolet Biomedical Instruments | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 7, 2024 | 93969 | Class II | Ongoing | TENSIVE Conductive Adhesive Gel, REF 016-401600 | Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five complaints. These customers reported that the gel is too thick, is discolored (darker than usual), and in one instance, patients reported irrit | accessdata.fda.gov |
| February 1, 2018 | 80023 | Class II | Terminated | Nicolet Ambulatory EEG | Potential to be able to import an ambulatory exam for a patient for which the exam was not started. | accessdata.fda.gov |
| June 9, 2017 | 77569 | Class II | Terminated | Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. | Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow. | accessdata.fda.gov |
| September 11, 2015 | 71991 | Class II | Terminated | NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, meas | When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals. | accessdata.fda.gov |
| February 27, 2013 | 64479 | Class II | Terminated | Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to b | Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn. | accessdata.fda.gov |
| December 16, 2011 | 60797 | Not yet classified | Terminated | NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid | Under certain work flow processes, when selecting a new patient name in NicVue, the associated exams list may not properly refresh, and may continue to display the previous patient's exams. | accessdata.fda.gov |
| October 5, 2011 | 60223 | Not yet classified | Terminated | NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes. Also, it has been determined that the stimulus c | accessdata.fda.gov |
| January 6, 2009 | 50875 | Not yet classified | Terminated | Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuri | Internal testing has identified several several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. These issues can be corrected by installing the Version 6.0 b045 software updating the Audio Driver and updating to XP Service Pack 3. Additionally, improper wirin | accessdata.fda.gov |
| September 16, 2008 | 49546 | Not yet classified | Terminated | GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can be used | GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Correction: GSI Audera units with version 2.6 software may mislabel Auditory Evoked Potential (AEP) waveform responses with respect to the identification of the stimulus ear. When using | accessdata.fda.gov |
| June 13, 2008 | 49350 | Not yet classified | Terminated | NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connecti | NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. Cardinal Health NeuroCare has confirmed that the 3rd party room relay connected to the A2 wall plate does not always activate if the patient event button connected to the CSeries Amplifier is pressed twice within one second. | accessdata.fda.gov |
| June 5, 2008 | 48758 | Not yet classified | Terminated | NicoletOne photic adapter cable 085-463700 | Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the NicLED Photic Strobe option, part number 698-625500, with NicoletOne EEG system. The photic adapter cable has a wiring error which delivers a reduced voltage and results in a decreased intensity of | accessdata.fda.gov |
| September 11, 2007 | 45328 | Not yet classified | Terminated | Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-6 | Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option. | accessdata.fda.gov |
| July 17, 2007 | 38424 | Not yet classified | Terminated | BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI | The BMSI "MicroJack" patient interface electrode connection device used with the EEG monitor systems was found to be mis-wired. A complainant alleged that during depth electrode EEG study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output. | accessdata.fda.gov |
| August 25, 2006 | 36241 | Not yet classified | Terminated | NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems. | A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in all channels on NicoletOne LTM, Sleep, nEEG, vEEG or ICU Monitor systems. | accessdata.fda.gov |
| April 28, 2006 | 35416 | Not yet classified | Terminated | VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each box contains 10 pouches | The Bar Electrodes do not meet performance specification for electrode impedance. A manufacturing defect was discovered in disposable bar electrodes, part number 019-435600, lot 604664, that has the potential to reduce the amplitude of a motor or sensory nerve action potential. These possible lower amplitudes will be measured only if the bar electrode is use | accessdata.fda.gov |
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Updated January 22, 2025. 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.