13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Trilogy
FDA UDI
Respironics, Inc.·00606959043046·Trilogy Ventilator Oximetry Interface Kit (allo...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608617·MAQUET 2" DELUXE
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
FDA 510(k)
FDA Class 2
·Anesthesiology
AUTO-DRIVE LAG SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
FATHOM GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - FREMONT·Product code DQX·June 16, 2011
SUPERDIMENSION INREACH BRONCHUS SYSTEM
FDA Adverse Event
Malfunction
·SUPERDIMENSION INC.·Product code JAK·September 16, 2015
VASOVIEW 6 PRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·April 24, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 9, 2014
FATHOM GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·February 23, 2010
FATHOM GUIDEWIRE
FDA Adverse Event
Injury
·SALT LAKE CITY·Product code DQX·February 23, 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