2 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
FDA Enforcement
Class II
·Terminated·Fujifilm Medical System USA, Inc.·May 28, 2014
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.
FDA Enforcement
Class II
·Terminated·Steris Corporation·November 13, 2013