4 results
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24ms
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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Cordis Angiographic Needles - Two-Piece Angiographic Needle with Snap-On Wing
Device
EU MDR
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Eu Md Class 2a
·Cordis Cashel·On the market·32 countries
Cordis Angiographic Needles - Two-Piece Angiographic Needle with Snap-On Wing
Device
EU MDR
·
Eu Md Class 2a
·Cordis Cashel·On the market·32 countries
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 25, 2018
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Ireland, Inc.·January 28, 2026