Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Recently-Approved Devices

Recently-Approved Devices

                        2023 Device Approvals
          2022 Device Approvals
          2021 Device Approvals Home
          Medical Devices
          Products and Medical Procedures
          Device Approvals, Denials and Clearances
          Recently-Approved Devices
          2022 Device ApprovalsRecently-Approved Devices 2022 Device Approvals
  
  	
    Share
    Post
    Linkedin

    Email
    PrintThe 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
			DateFlexAbility Ablation Catheter, Sensor Enabled - P110016/S080
			Catheter
			12/14/2022Agilent Resolution ctDx FIRST - P210040
			Lab Test
			12/12/2022Magtrace and Sentimag Magnetic Localization System - P160053/S002
			Biopsy guide
			12/06/2022Chocolate Touch Paclitaxel Coated PTA Ballon Catheter - P210039
			Catheter
			11/04/2022VENTANA FOLR1 (FOLR-2.1) RxDx Assay - P220006
			Lab Test
			11/14/2022Avive Automated External Defibrillator (AED) and Accessories - P210015
			Defibrillator
			10/31/2022The Spanner Temporary Prostatic Stent - P060010/S013
			Stent
			10/07/2022PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody - P990081/S047
			Lab Test
			09/30/2022Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System - P160043/S058
			Stent
			09/15/2022Oncomine Dx Target Test - P160045/S031
			Lab Test
			09/21/2022LungFit PH - P200044
			Lung Ventilator
			06/28/2022PASCAL Precision Transcatheter Valve Repair System - P220003
			Heart valve
			09/14/2022Aptima CMV Quant Assay - P210029
			Lab Test
			05/09/2022IC-8 Apthera Intraocular Lens (IOL) - P210005
			Lens
			07/22/2022NeVa VS - H210004
			Stent
			09/09/2022Oncomine Dx Target Test - P160045/S035
			Lab Test
			08/11/2022Guardant360 CDx - P200010/S008
			Lab Test
			08/11/2022ARCHITECT HBsAg NEXT Qualitative Reagent Kit - P210003
			Lab Test
			08/10/2022Stellarex 0.035 OTW Drug-coated Angioplasty Ballon - P160049/S015
			Angioplasty Ballon
			03/25/2022BioFreedom Drug Coated Coronary Stent System - P190020
			Stent
			05/13/2022JUVEDERM VOLUX XC - P110033/S065
			Gel implants or Dermal filler
			07/29/2022ADVIA 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
			05/27/2022SBL-3 Multifocal Intraocular Lens – P200020
			Multifocal Intraocular Lens
			05/22/2022AccelStim Bone Growth Stimulator – P210035
			Stimulator
			05/03/2022Organ Care System (OCS) Heart System - P180051/S001
			Portable Enclosure
			04/27/2022Thoraflex Hybrid - P210006
			Aneurysm
			04/19/2022Et Control - P210018
			Software Feature
			03/17/2022Evoke Spinal Cord Stimulation (SCS) System - P190002
			Spinal Cord Stimulation System
			02/28/2022CardioMEMS HF System - P100045/S056
			Heart Monitor
			02/18/2022Prometra Programmable Infusion Pump System - P080012/S068
			Infusion Pump
			01/12/2022Nucleus 24 Cochlear Implant System - P970051/S205
			Cochlear Implant
			01/10/2022Senza Spinal Cord Stimulation (SCS) System - P130022/S042
			Spinal Stimulation System
			01/17/2022Eversense E3 Continuous Glucose Monitoring System - P160048/S016
			Glucose Monitor
			02/10/2022eCoin Peripheral Neurostimulator - P200036
			Bladder Control
			03/01/2022FoundationOne CDx - P170019/S029
			Lab Test
			02/18/2022EVO/EVO+ VISIAN Implantable Collamer Lens - P030016/S035
			Implantable Collamer Lens
			03/25/2022Aveir 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
			03/31/2022Alinity m CMV Assay – P210022
			Lab Test
			05/05/2022ENROUTE Transcarotid Stent System – P140026/S016
			Stent
			04/28/2022GORE TAG Thoracic Branch Endoprosthesis – P210032
			Stent
			05/13/2022FoundationOne CDx – P170019/S014
			Lab Test
			05/31/2022

                                                                                  Content current as of:
      03/10/2023
              
              
Regulated Product(s)
		 Medical DevicesRecently-Approved Devices

          
                        2023 Device Approvals
          2022 Device Approvals
          2021 Device Approvals
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop