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  1. Recently-Approved Devices

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



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