11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RADIATION PROTECTION GLASSES
FDA 510(k)
FDA Class 1
·Radiology
SCANLAN® Dilators
FDA UDI
SCANLAN INTERNATIONAL INC·00846159031478·Garrett Vascular Dilator
FLOCONTROL , MODEL 1028
FDA 510(k)
FDA Class 2
·Cardiovascular
STAINLESS STEEL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSURE SP NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·June 11, 2010
ADVIA CENTAUR XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·June 30, 2014
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·November 17, 2010
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 13, 2012
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·April 24, 2020
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