3 results
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56ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
FDA Enforcement
Class II
·Terminated·Vital Diagnostics, Inc.·January 22, 2014
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
FDA Enforcement
Class II
·Terminated·Vital Diagnostics, Inc.·January 22, 2014
VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.
FDA Enforcement
Class II
·Terminated·Vital Images, Inc.·November 13, 2013