9 results
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26ms
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Sources: EU EUDAMED, US FDA
DENCLENZ
FDA 510(k)
FDA Class 1
·Dental
SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE
FDA 510(k)
FDA Class 1
·Physical Medicine
SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 11, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 9, 2014
MAXIMO II DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 5, 2010
ZERO-P CONVEX H5 PEEK
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·December 3, 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