6 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
FDA Recall
Terminated
·Luminex Corporation·Product code OOI·November 17, 2021
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
FDA Recall
Terminated
·Luminex Corporation·Product code OOI·April 16, 2021
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
FDA Enforcement
Class II
·Terminated·Luminex Corporation·February 9, 2022
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
FDA Enforcement
Class II
·Terminated·Luminex Corporation·January 26, 2022
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
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016