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
FlexAbility Ablation Catheter, Sensor Enabled - P110016/S080	Catheter	12/14/2022
Agilent Resolution ctDx FIRST - P210040	Lab Test	12/12/2022
Magtrace and Sentimag Magnetic Localization System - P160053/S002	Biopsy guide	12/06/2022
Chocolate Touch Paclitaxel Coated PTA Ballon Catheter - P210039	Catheter	11/04/2022
VENTANA FOLR1 (FOLR-2.1) RxDx Assay - P220006	Lab Test	11/14/2022
Avive Automated External Defibrillator (AED) and Accessories - P210015	Defibrillator	10/31/2022
The Spanner Temporary Prostatic Stent - P060010/S013	Stent	10/07/2022
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody - P990081/S047	Lab Test	09/30/2022
Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System - P160043/S058	Stent	09/15/2022
Oncomine Dx Target Test - P160045/S031	Lab Test	09/21/2022
LungFit PH - P200044	Lung Ventilator	06/28/2022
PASCAL Precision Transcatheter Valve Repair System - P220003	Heart valve	09/14/2022
Aptima CMV Quant Assay - P210029	Lab Test	05/09/2022
IC-8 Apthera Intraocular Lens (IOL) - P210005	Lens	07/22/2022
NeVa VS - H210004	Stent	09/09/2022
Oncomine Dx Target Test - P160045/S035	Lab Test	08/11/2022
Guardant360 CDx - P200010/S008	Lab Test	08/11/2022
ARCHITECT HBsAg NEXT Qualitative Reagent Kit - P210003	Lab Test	08/10/2022
Stellarex 0.035 OTW Drug-coated Angioplasty Ballon - P160049/S015	Angioplasty Ballon	03/25/2022
BioFreedom Drug Coated Coronary Stent System - P190020	Stent	05/13/2022
JUVEDERM VOLUX XC - P110033/S065	Gel implants or Dermal filler	07/29/2022
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