7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
DELTANODE, MEGA DELTA, DELTA LINK-
FDA 510(k)
FDA Class 1
·Radiology
XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A
FDA 510(k)
FDA Class 2
·Physical Medicine
Canvas Dx
FDA 510(k)
FDA Class 2
·Neurology
PALINDROME EMERALD 23/40 KIT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·October 24, 2012
ALERE HCG COMBO CASSETTE (20/10)
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 25, 2014
1-DAY ACUVUE TRUEYE NARAFILCON-A
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·September 22, 2010
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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