8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TYMPANOSTOMY (VENTILATION) TUBE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
FDA 510(k)
FDA Class 2
·Orthopedic
TITANIUM MESH IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
HEMOCHRON SIGNATURE ELITE
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS·Product code JPA·May 25, 2016
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 31, 2013
CE MULTIRATE INFUSOR LV2,3,512 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 29, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020