5,593 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNKNOWN
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code DTB·August 12, 2023
UNKNOWN
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code DTB·August 11, 2023
MRI TESLA 3
FDA Adverse Event
Injury
·UNK·Product code LNH·February 23, 2022
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code OJX·August 12, 2023
Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005
SIEMENS 1.5T MRI MACHINE
FDA Adverse Event
Injury
·SIEMENS·Product code LNH·November 8, 2016
MAGNETOM SKYRA
FDA Adverse Event
Injury
·SIEMENS HEALTHCARE GMBH·Product code LNH·December 19, 2016
HORIZON LX 1.5T
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code LNH·December 12, 2016
ACHIEVA 1.5T NEW
FDA Adverse Event
Injury
·PHILIPS HEALTHCARE·Product code LNH·December 22, 2016
SYS 9734070R POLESTAR N30 REWORK
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (ISRAEL)·Product code LNH·December 7, 2016
ACHIEVA 1.5T NOVA
FDA Adverse Event
Injury
·PHILIPS HEALTHCARE·Product code LNH·November 30, 2016
1.5T HDX ECHOSPEED 8 CHANNEL
FDA Adverse Event
Death
·GE MEDICAL SYSTEMS, LLC·Product code LNH·October 18, 2016
ACHIEVA 1.5T NOVA
FDA Adverse Event
Injury
·PHILIPS HEALTHCARE·Product code LNH·November 15, 2016
INTERA 1.5T
FDA Adverse Event
Injury
·PHILIPS HEALTHCARE·Product code LNH·July 13, 2015
MAGNETOM AERA
FDA Adverse Event
Injury
·SIEMENS GMBH·Product code LNH·July 6, 2015
3.0T SIGNA HDXT
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code LNH·September 4, 2015
OASIS
FDA Adverse Event
Injury
·HITACHI MEDICAL CORPORATION·Product code LNH·July 9, 2015
INTERA 1.5T ACHIEVA PULSAR
FDA Adverse Event
Injury
·PHILIPS HEALTHCARE·Product code LNH·July 29, 2015
ACHIEVA 1.5T NOVA
FDA Adverse Event
Injury
·PHILIPS HEALTHCARE·Product code LNH·February 1, 2012
SIGNA OPENSPEED
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code LNH·January 11, 2012