13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDCOMP SPLIT-CATH II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502822·Leksell Coordinate Frame G
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503263·Leksell Coordinate Frame G - POSTERIOR MEMBER
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503249·Leksell Coordinate Frame G - STRAIGHT FRONT PIECE
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101260·SS Suture, 2 per sleeve
PRIMA OXYGEN MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 19, 2025
TERUMO STERNAL SAW II
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code GFA·April 3, 2013
HUT EXT DR FINAL ASSY-REVERSE
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·February 15, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC INC·Product code FRN·May 8, 2008
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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