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  1. Recently-Approved Devices

2022 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2022. The products in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

Medical Devices Cleared or Approved by FDA in 2022

Device Name Category Date
ADVIA Centaur HBc Total 2 (HBcT2), ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC), Atellica IM HBc Total 2 (HBcT2), Atellica IM HBc Total 2 Quality Control (HBcT2 QC) – P210019 Lab Test 05/27/2022
SBL-3 Multifocal Intraocular Lens – P200020 Multifocal Intraocular Lens 05/22/2022
AccelStim Bone Growth Stimulator – P210035 Stimulator 05/03/2022
Organ Care System (OCS) Heart System - P180051/S001 Portable Enclosure 04/27/2022
Thoraflex Hybrid - P210006 Aneurysm 04/19/2022
Et Control - P210018 Software Feature 03/17/2022
Evoke Spinal Cord Stimulation (SCS) System - P190002 Spinal Cord Stimulation System 02/28/2022
CardioMEMS HF System - P100045/S056 Heart Monitor 02/18/2022
Prometra Programmable Infusion Pump System - P080012/S068 Infusion Pump 01/12/2022
Nucleus 24 Cochlear Implant System - P970051/S205 Cochlear Implant 01/10/2022
Senza Spinal Cord Stimulation (SCS) System - P130022/S042 Spinal Stimulation System 01/17/2022
Eversense E3 Continuous Glucose Monitoring System - P160048/S016 Glucose Monitor 02/10/2022
eCoin Peripheral Neurostimulator - P200036 Bladder Control 03/01/2022
FoundationOne CDx - P170019/S029 Lab Test 02/18/2022
EVO/EVO+ VISIAN Implantable Collamer Lens - P030016/S035 Implantable Collamer Lens 03/25/2022
Aveir Leadless Pacing System – Aveir Leadless Pacemaker, Model LSP112V (Right Ventricular); Aveir Delivery Catheter, Model LSCD111; and Aveir Link Module, Module LSL02 – P150035 Leadless Pacemaker System 03/31/2022
Alinity m CMV Assay – P210022 Lab Test 05/05/2022
ENROUTE Transcarotid Stent System – P140026/S016 Stent 04/28/2022
GORE TAG Thoracic Branch Endoprosthesis – P210032 Stent 05/13/2022
FoundationOne CDx – P170019/S014 Lab Test 05/31/2022

 

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