8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
FDA 510(k)
FDA Class 1
·Cardiovascular
SPPHINE PLUS STM 3W DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014
M2A-MAGNUM 42-50MM TPR INSRT-6
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 31, 2012
TRIDENT PSL HA CLUSTER 56MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·August 16, 2010
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·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