9 results
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27ms
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Sources: EU EUDAMED, US FDA
REMOTE CONTROL SWITCH
FDA 510(k)
FDA Class 2
·Physical Medicine
WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1
FDA 510(k)
FDA Class 2
·General Hospital
LIBERTE' MONORAIL STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MAF·September 27, 2006
ZOLL IVTM ICY CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC·Product code NCX·June 30, 2014
SPECTRUM
FDA Adverse Event
Malfunction
·SIGMA·Product code FRN·October 15, 2010
HYDROVIEW INTRAOCULAR LENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQL·January 3, 2013
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017