10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SMI DIGITRON
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LEADER
FDA UDI
Cardinal Health 110, Inc.·00096295142822·LDR Sheer Adhesive Bandage Sterile 3/4" x 3" 10...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136353·
ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
THE STORK OTC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BLOCKING SCREW FOR TRANSPALATAL DISTRACTOR
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JEY·May 12, 2016
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·May 30, 2014
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·June 26, 2012
UTERINE ARTERY EMBOLIZATION
FDA Adverse Event
Injury
·Product code NAJ·September 14, 2010
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018