8 results
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20ms
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Sources: EU EUDAMED, US FDA
SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MON-A-THERM MYOCARDIAL TEMP. SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
BAXA ADLI SEAL
FDA 510(k)
FDA Class 2
·General Hospital
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 25, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·November 5, 2010
RIGHT STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LZO·December 21, 2012
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