The following new items were added to the CDRH web pages on April 10, 2018. Previous CDRH Newitems can be found on the CDRH New webpage.
- UPDATE: Use of Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing of Certain Duodenoscopes: FDA Safety Communication
- TransMedics, Inc. TransMedics OCS Lung System – P160013
- HeartSine samaritan® Public Access Defibrillators (PAD) - P160008
- Guardian Connect System - P160007