8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IGUIDE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Avail
FDA 510(k)
FDA Class 2
·Neurology
ESSURE
FDA Adverse Event
BAYER PHARMA AG·Product code HHS·May 29, 2014
PRODISC-C IMPLANT MEDIUM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·October 11, 2010
UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code MMI·December 13, 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