8 results
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20ms
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Sources: EU EUDAMED, US FDA
SANODENT DOUBLE-ENDED INTERDENTAL CLEAN
FDA 510(k)
FDA Class 1
·Dental
SPOT CHECK PULSE OXIMETER,512/513
FDA 510(k)
FDA Class 2
·Cardiovascular
PELLEFIRM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LC PCA III INFUSER
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·March 26, 2014
PINN SECTOR W/GRIPTION 50MM
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·November 15, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 13, 2010
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