9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O
FDA 510(k)
FDA Class 1
·Microbiology
ILIF
FDA UDI
Nuvasive, Inc.·00887517262813·Tray - Interspinous Instruments (Base)
InZone Detachment System
FDA 510(k)
FDA Class 2
·Neurology
MODULAR TROCAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMECHOICE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 18, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·July 9, 2010
UNKNOWN
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 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