3 results
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14ms
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Sources: EU EUDAMED, US FDA
CF InPlex ASR Card; Catalog Number: 95-0501.
FDA Enforcement
Class II
·Terminated·Hologic, Inc·May 4, 2016
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
FDA Enforcement
Class II
·Terminated·Hologic, Inc·May 4, 2016
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
FDA Enforcement
Class II
·Terminated·Med-Hot Thermal Imaging, Inc.·May 17, 2017