8 results
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17ms
·
Sources: EU EUDAMED, US FDA
STERILE SILICONE TUBING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317359223·
STYLO Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
COR ANALYZER
FDA 510(k)
FDA Class 2
·Radiology
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·April 25, 2014
LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDO·November 13, 2007
INRATIO2
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·October 24, 2012
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