CDRH New Update

The following new items were added to the CDRH web pages on August 10, 2018. Previous CDRH New items can be found on the CDRH New webpage. Class I Recall: Arkon Anesthesia Delivery System recalled due to unexpected failed state while in use or idle Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170052 added) Class I Recall: Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery Press Release: FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy