5 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
FDA Enforcement
Class II
·Ongoing·Ortho8, Inc.·August 25, 2021
ViewPoint; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.
FDA Enforcement
Class III
·Ongoing·Linet Americas·August 19, 2020
3mensio Workstation (Vascular Fenestrated) software
FDA Enforcement
Class II
·Ongoing·PIE Medical Imaging B.V.·August 20, 2025
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024