216 results
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50ms
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Sources: EU EUDAMED, US FDA
RetCam Portable
FDA UDI
NATUS MEDICAL INC·00864222000428·The RetCam Portable Ophthalmic Imaging System i...
RetCam 3
FDA UDI
NATUS MEDICAL INC·00864222000404·RetCam 3 Ophthalmic Imaging System is designed ...
RetCam Shuttle
FDA UDI
NATUS MEDICAL INC·00864222000411·The RetCam Shuttle Ophthalmic Imaging System is...
CLARITY HEARING SCREENER
FDA Adverse Event
Malfunction
·SONAMED CORP (SUBSEQUENTLY/RECENTLY ACQUIRED BY NATUS MEDICAL INC, MUNDELIN, IL)·Product code GWJ·April 26, 2011
OLYMPIC COOL-CAP SYSTEM
FDA Adverse Event
Malfunction
·NATUS MEDICAL INC.·Product code MXM·February 5, 2010
OLYMPIC COOL-CAP SYSTEM
FDA Adverse Event
Malfunction
·NATUS MEDICAL INCORPORATED·Product code MXM·August 2, 2011
OLYMPIC COOL-CAP SYSTEM
FDA Adverse Event
Malfunction
·NATUS MEDICAL INC·Product code MXM·August 11, 2010
FLEXICOUPLER DISPOSABLE EAR PHONES
FDA Adverse Event
Malfunction
·NATUS MEDICAL INC.·Product code GWJ·October 12, 2017
OLYMPIC COOL-CAP SYSTEM
FDA Adverse Event
Malfunction
·NATUS MEDICAL INC.,·Product code MXM·July 11, 2011
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
INTEGRA CAMINO ICP MONITOR
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES (IRELAND) LIMITED·Product code GWM·June 27, 2018
Natus Manufacturing Ltd
Authorized representative
🇮🇪 Ireland·4 Manufacturers
natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
FDA Recall
Open, Classified
·Natus Neurology Inc·Product code GYB·February 7, 2024
NT821731C, EDS 3, GEN LL, NO CATHETER
FDA Adverse Event
Malfunction
·NATUS MEDICAL INCORPORATED·Product code JXG·November 25, 2025
COOL-CAP
FDA Adverse Event
Malfunction
·NATUS MEDICAL INC.·Product code MXM·October 26, 2016
TM-ECOCHGTRODE
FDA Adverse Event
Other
·NATUS MEDICAL INC·Product code GXY·January 9, 2009
NATUS
FDA Adverse Event
Malfunction
·NATUS MEDICAL INC·Product code EWO·February 11, 2010
OLYMPIC COOL-CAP SYSTEM
FDA Adverse Event
Malfunction
·NATUS MEDICAL INC·Product code MXM·June 24, 2010
COOL-CAP
FDA Adverse Event
Death
·NATUS MEDICAL INC·Product code MXM·October 27, 2016