3 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 15, 2017
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014