CDRH New Update

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