7 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
FDA Enforcement
Class II
·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·July 30, 2025
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: OBM00002 OBM DAB (Digital Acquisition Box) Component: No
FDA Enforcement
Class II
·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·June 18, 2025
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 signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·January 13, 2016
XLTEK EMU40EX EEG Headbox
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 8, 2018
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 documentation.
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·April 8, 2020
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·March 2, 2022