8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FOX EYE SHIELDS
FDA 510(k)
FDA Class 1
·Ophthalmic
MSI
FDA UDI
Modern Surgical Instruments LLC·B4198100980·
SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO CAVERMAP SURGICAL AID
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 10, 2014
NC QUANTUM APEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·October 31, 2012
PUMP MMT-522NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 16, 2010
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