CDRHNew - News and Updates

CDRHNew - News and Updates

The following new items were added to the CDRH web pages on April 3, 2019. Previous CDRH Newitems can be found on the CDRH New webpage. Consumer Information on: TRILURON™ - P180040 Mammography Facility Adverse Event and Action Report - April 02, 2019: DMI Clinic - Carl J. Kubek Class I Recall: O-Two Medical Technologies, Inc. Recalls o_two e700, e600 and e500 Automatic Transport Ventilators Due to Potential Risk of Fire Transcript posted for Feb. 12, 2019 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting Federal Register: Medical Device Accessories