7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DIASAFEplusUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPTIGEN TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFANT SLEEP BEANIE
FDA 510(k)
FDA Class 1
·General Hospital
CANNULATED 4.0MM HEXAGONAL SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HXX·June 21, 2013
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 8, 2014
CLAMP, THORACIC, RADIOLUCENT
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 11, 2011
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018