8 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·August 26, 2015
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·February 11, 2015
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·March 16, 2016
RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
FDA Recall
Terminated
·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·July 13, 2015
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
FDA Recall
Terminated
·Sedecal S.A. Pol. Industrial Rio De Janiero Calle Pelaya 9-13 Algete Spain·Product code IZL·January 18, 2016
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
FDA Recall
Terminated
·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·August 6, 2014
Sedecal SA Mobile Diagnost w DR x-ray system
FDA Recall
Terminated
·Sedecal USA, Inc.·Product code IZL·March 23, 2015
Sedecal SA Mobile Diagnost w DR x-ray system
FDA Enforcement
Class II
·Terminated·Sedecal USA, Inc.·June 15, 2016