BEUDAMED
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    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Recall
    Open, Classified ·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017

    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Recall
    Open, Classified ·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017

    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code GKA·April 7, 2022

    Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

    FDA Recall
    Open, Classified ·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 2023

    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 Recall
    Open, Classified ·Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland·Product code LBS·December 8, 2025