8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BI-CENTRIC BI-POLAR ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG
FDA 510(k)
FDA Unclassified
·Unknown
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014
MATOME STEREOTACTIC 11 G PROBE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code KNW·November 12, 2007
3.5MM CORTEX SCREW SLF TPING 14MM
FDA Adverse Event
Injury
·SYNTHES, INC.·Product code HWC·October 18, 2012
PREVENT NEEDLE ONLY 25 X 1
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMI·November 7, 2018
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017