8 results
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21ms
·
Sources: EU EUDAMED, US FDA
DALE ENDOTRACHEAL TUBE HOLDER
FDA 510(k)
FDA Class 1
·Anesthesiology
Yumizen H2500
FDA 510(k)
FDA Class 2
·Hematology
SOFTECH PLUS ETC02 CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology
PLM A+ SPANISH 110V
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 26, 2014
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·November 15, 2012
COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·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