516 results
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38ms
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Sources: EU EUDAMED, US FDA
*
FDA Adverse Event
Malfunction
·STELLATE SYSTEMS·Product code GWQ·March 10, 2010
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 25, 2015
EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM
FDA Adverse Event
Injury
·SALUDA MEDICAL PTY LTD·Product code LGW·December 11, 2025
Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC-LT2; HSYS-REC-EAMP) Harmonie-S Sleep System (Model HSYS-REC-DUO) VITA/ICU Neurological Monitoring System (Model HSYS-REC-DUO-PPC) Harmonie{-S}{-E} Readers (Models HSYS-RDR-D, HSYS-RDR-T). Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations.
FDA Recall
Terminated
·Stellate Systems·Product code GWQ·April 16, 2009
CABLE 1.0MMX750XX W/CRIMP
FDA Adverse Event
Malfunction
·SYNTHES INC.·Product code JDQ·December 14, 2016
Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,
FDA Recall
Terminated
·Stellate Systems·Product code GWQ·April 6, 2009
Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,
FDA Enforcement
Class II
·Terminated·Stellate Systems·May 1, 2013
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·June 14, 2022
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·April 18, 2024
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·September 29, 2022
EPSILA EV¿ MRI SURESCAN¿
FDA Adverse Event
Injury
·MPRI·Product code NVY·March 12, 2025
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·August 7, 2023
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·May 13, 2026
EPSILA EV¿
FDA Adverse Event
Injury
·MPRI·Product code NVY·March 12, 2025
AURORA EV-ICD¿ MRI SURESCAN¿
FDA Adverse Event
Injury
·MEDTRONIC EUROPE SARL·Product code LWS·March 12, 2025
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·January 5, 2021
IMPELLA 5.5
FDA Adverse Event
Injury
·ABIOMED, INC·Product code OZD·April 19, 2024
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·August 28, 2015
LIGACLIP*MCA MED LONG APPLIER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·September 27, 2023
IMPLANTABLE COLLAMER LENS (ICL)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code QCB·May 6, 2024