11 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CorPath GRX System
FDA 510(k)
FDA Class 2
·Cardiovascular
KIMGUARD ONE STEP STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
FIBROSCAN
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 20, 2024
ACT 5DIFF RINSE
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JCB·June 17, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 24, 2011
11 CM ANGLE ATTACHMENT QD11
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 15, 2014
COBAS TAQSCREEN MPX TEST, V2.0, CE-IVD
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS·Product code MZP·January 8, 2016
COBAS TAQSCREEN MPX TEST, V2.0, CE-IVD
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS·Product code MZP·January 8, 2016
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
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