4 results
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48ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
FDA Enforcement
Class II
·Terminated·Elcam Medical, Inc.·September 16, 2015
Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
FDA Enforcement
Class II
·Terminated·Elcam Medical, Inc.·April 26, 2017
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.
FDA Enforcement
Class II
·Terminated·Elcam Medical, Inc.·September 16, 2015
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 23, 2014