4 results
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6ms
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Sources: EU EUDAMED, US FDA
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
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·September 27, 2023
Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items
FDA Enforcement
Class II
·Terminated·Natus Manufacturing Limited·January 18, 2017
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