Recently Approved Devices

TransMedics, Inc. TransMedics OCS Lung System – P160013The TransMedics OCS Lung System is designed to preserve donor lungs prior to transplantation. The OCS Lung System includes a portable enclosure with mechanical and electrical components used to ventilate and perfuse the lungs (supply with fluid), as well as a lung preservation solution.

HeartSine samaritan® SAM 350P, SAM 360P, and SAM 450P PADs and Accessories – P160008
The HeartSine samaritan® Public Access Defibrillators (PAD) 350P, 360P, and 450P are portable, battery operated, defibrillators designed to treat people experiencing sudden cardiac arrest (SCA), a medical condition in which the heart suddenly and unexpectedly stops beating.

Guardian Connect System – P160007
The Guardian Connect System is a continuous glucose monitoring (CGM) system that measures sugar (glucose) levels every 5 minutes and displays the values through the Guardian Connect app installed on a compatible mobile device (i.e., an iPhone or iPad). The System allows users to detect trends and track patterns in glucose concentrations to help keep blood glucose levels in a safe range. Diabetes is a disease in which your blood sugar or blood glucose levels can go too low or too high.