10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIASYS WITH MODELS LIASYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Regent
FDA UDI
SPINAL ELEMENTS·00840916115029·Regent ACP 4-Level, 68mm
CHIN ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
RANDOX COMPLEMENT C4
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code OTN·April 24, 2013
HAKIM VALVE
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·April 22, 2011
PHILOS II DR
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DXY·July 21, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018