8 results
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47ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
FDA Enforcement
Class II
·Ongoing·Natus Neurology Inc·March 27, 2024
TENSIVE Conductive Adhesive Gel, REF 016-401600
FDA Enforcement
Class II
·Ongoing·Natus Neurology Inc·March 27, 2024
Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Enforcement
Class II
·Terminated·Natus Neurology Inc·July 19, 2017
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.
FDA Enforcement
Class II
·Terminated·Natus Neurology Inc·July 19, 2017
Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Enforcement
Class II
·Terminated·Natus Neurology Inc·July 19, 2017
Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Enforcement
Class II
·Terminated·Natus Neurology Inc·July 19, 2017
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, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data
FDA Enforcement
Class II
·Terminated·Natus Neurology Inc·October 21, 2015
Nicolet¿ Ambulatory EEG
FDA Enforcement
Class II
·Terminated·Natus Neurology Inc·August 8, 2018