8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PHADEXACT SERUM, TOTAL IGE CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
CarePartner Home Communicator
FDA UDI
Lifeline Systems Company·00884838071599·6800XT Unlocked Refurbished Home Communicator
STORZ MODULITH, MODEL SLX-F2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARTHREX FIBERTAK SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
TRELLIS 6 120X30
FDA Adverse Event
Malfunction
·COVIDIEN·Product code KRA·May 30, 2014
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 20, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 12, 2015
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