14 results
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35ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 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 Recall
Terminated
·Elcam Medical, Inc.·Product code LZG·July 19, 2015
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 Recall
Terminated
·Elcam Medical, Inc.·Product code LZG·July 19, 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 Recall
Terminated
·Elcam Medical, Inc.·Product code FMG·February 2, 2017
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 Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·May 15, 2012
e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·February 10, 2003
e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS--·September 5, 2003
ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code JWM·February 10, 2003
Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·December 18, 2008
Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system with flexible patient positioning for planar imaging, whole-body scans, and SPECT studies.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·May 15, 2012
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
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 Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·April 23, 2014