85 results
·
41ms
·
Sources: EU EUDAMED, US FDA
NEUROFEEDBACK
FDA Adverse Event
Injury
·EEG INFO·Product code HCC·February 24, 2016
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
FDA Recall
Terminated
·EEG Info·Product code HCC·November 15, 2012
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
FDA Enforcement
Class II
·Terminated·EEG Info·December 26, 2012
SEDLINE MODULE PATIENT CABLE
FDA Adverse Event
Death
·MASIMO CORPORATION·Product code GWQ·September 24, 2014
NIHON KOHDEN NE-136A ELECTRODE
FDA Adverse Event
Injury
·NIHON KOHDEN CORPORATION·Product code GWQ·May 23, 2008
NUPREP GEL
FDA Adverse Event
Injury
·D.O. WEAVER AND CO·Product code GYB·March 29, 2007
ITREL II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LGW·November 2, 2009
AXON ECLIPSE INTRAOPERATIVE NEUROMONITOR 32 CHANNEL
FDA Adverse Event
Injury
·MEDTRONIC·Product code GWM·August 2, 2011
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 25, 2011
BRAVO MULTI MODALITY SYSTEM
FDA Adverse Event
Malfunction
·NICOLET BIOMEDICAL INC.·Product code GWQ·July 24, 2003
LICOX COMPLETE BRAIN IMC-PROBE KIT
FDA Adverse Event
Malfunction
·GMS-GESSELLSCHAFT FUR MEDIZINISCHE·Product code GWM·April 4, 2002
PROTECTIVE PLUS SAFETY IV CATHETER
FDA Adverse Event
Injury
·SMITHS MEDICAL·Product code FOZ·June 8, 2018
CYGNET EEG
FDA Adverse Event
Injury
·BEE SYSTEMS·Product code HCC·May 1, 2016
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·April 22, 2010
ENTERRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LNQ·June 19, 2009
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 25, 2008
TEN20 CONDUCTIVE
FDA Adverse Event
Other
·D.O. WEAVER AND COMPANY·Product code GYB·August 24, 2010
NUPREP GEL
FDA Adverse Event
Other
·D.O. WEAVER AND COMPANY·Product code GYB·August 24, 2010
PLUM A+3 MULTICHANNEL INFUSION PUMP
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code FRN·February 4, 2003
SYNCHROMED
FDA Adverse Event
Other
·MEDTRONIC, INC.·Product code LKK·May 14, 1997