12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SCANSCOPE XT SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
TruForm
FDA UDI
Rmo, Inc.·00885797100030·MN 2MOL BD KT STD NO/L R&L 178
Conformis Hip System
FDA UDI
Conformis, Inc.·00850268007583·REMOVER, FEMORAL HEAD, QC
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606231·MAQUET ALPHASTAR 1132 4.25" DELUXE GEL
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 26, 2013
MICRO-DRIVER RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MAF·April 22, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·July 17, 2008
RUNTHROUGH NS
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018
RUNTHROUGH NS
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018
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