Day

July 7, 1999
7-July-99 Olympus. Class III field correction. EPROM Version 3.00 Software for the Olympus EVIS CV-140 Video System Center. The device has a malfunction due to incorrect coding of the software which can cause the software to overwrite the patient ID number with any comments that are entered by the user.. Z-1227-9IVD
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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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