Day

May 21, 1999
5/21/99 VIA Medical Corporation 59 units. Class II VIA Low Volume Mode (LVM) Monitor. The devices has a software problem that can cause the monitor, under unusual circumstances, to display and print a chemistry value from a previous sampling instead of the blood chemistry value from the current sampling. Z-1041-9.
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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