8 results
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20ms
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Sources: EU EUDAMED, US FDA
IL 482 CO-OXIMETER
FDA 510(k)
FDA Class 1
·Clinical Toxicology
AIR COMPRESSOR ADAPTOR KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
Trapper Exchange Device
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·June 10, 2014
ACID CONC.7149 CF 3500ML CAPTI/F/D/NL CE
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL S.P.A. - GROSOTTO ITALY·Product code FKQ·October 8, 2010
ON-Q C-BLOC: 600ML, 2-14ML/HR SELECT-A-FLOW
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code MEB·November 29, 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