Date: May 31, 2016
The following new items were added to the CDRH web pages on May 27, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- 2014 Ebola Virus Emergency Use Authorizations: Idylla™ Ebola Virus Triage Test (Biocartis NV) - May 26, 2016
- Mammography Facility Adverse Event and Action Report - May 27, 2016: Hawaii Radiologic Associates, Ltd.
- Class I Medical Device Recall: Medtronic Respiratory and Monitoring Solutions Recalls Battery Pack Used on Patient Monitors Due to Potential Fire Risk