136 results
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61ms
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Sources: EU EUDAMED, US FDA
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)
Manufacturer
🇨🇦 Canada·4 Importers
Zhenjiang Excellence Medical Tech Co.,LTD
Manufacturer
🇨🇳 China
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
FDA registration
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)·20 products·🇨🇦 Canada
EXCEL TECH LTD. NEUROMAX 1004
FDA Adverse Event
Injury
·EXCEL TECH. LTD.·Product code IKN·October 4, 1999
NEUROMAX CE 1004 BY NATUS / EXCEL-TECH LTD
FDA Adverse Event
NATUS/EXCEL-TECH XLTEK·Product code IKN·March 8, 2013
PROTEKTOR
FDA Adverse Event
Other
·EXCEL-TECH LTD.·Product code GWF·June 16, 2007
EXCEL ULTRA III
FDA Adverse Event
Injury
·EXCEL TECH LTD.·Product code IPF·August 1, 2011
EXCEL MULTI III
FDA Adverse Event
Injury
·EXCEL TECH LTD·Product code GZJ·August 6, 2004
XLTEK EMU40 EEG HEADBOX
FDA Adverse Event
Malfunction
·EXCEL-TECH LTD.·Product code GWQ·March 7, 2011
XLTEK EP16
FDA Adverse Event
Malfunction
·EXCEL TECH LTD.·Product code GWF·April 10, 2003
XLTEK EP16 LAPTOP
FDA Adverse Event
Malfunction
·EXCEL TECH. LTD.·Product code GWF·April 10, 2003
MOBEE 32
FDA Adverse Event
Malfunction
·EXCEL TECH. LTD.·Product code GWQ·May 5, 2003
EXCEL
FDA Adverse Event
Malfunction
·EXCEL TECH, LTD.·Product code GZJ·July 11, 2007
XL TEK EVOKED POTENITAL HEADBOX
FDA Adverse Event
Other
·EXCEL TECH. LTD.·Product code GWF·July 19, 2005
NEUROMAX 1000K
FDA Adverse Event
Malfunction
·EXCEL TECH LTD·Product code IKN·June 28, 2001
XLTEK EP16
FDA Adverse Event
Malfunction
·EXCEL TECH. LTD.·Product code GWF·August 1, 2006
EXCEL
FDA Adverse Event
Malfunction
·EXCEL TECH, LTD.·Product code GZJ·February 13, 2008
EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
FDA Recall
Terminated
·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWF·January 2, 2015
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 provide healthcare professionals with information to help assess patients neurological status during surgery.
FDA Recall
Terminated
·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWE·January 2, 2015
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 Recall
Terminated
·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code GWQ·November 11, 2015