CDRH New Update

The following new items were added to the CDRH web pages on June 22, 2018. Previous CDRH Newitems can be found on the CDRH New webpage. Class I Medical Device Recall: Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 Recalled Due to Misinterpretation of Display Messages for Out of Range Values Press Release: FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170004 and DEN160006 added)