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 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
          2023 Device ApprovalsRecently-Approved Devices 2023 Device Approvals
  
  	
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    PrintThe products listed in this section include some of the newest medical technology from the year 2023. 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 2023

Device Name
			Category
			DateRHA 3 dermal filler - P170002/S030
			Dermal Filler
			10/27/2023OncomineTM Dx Target Test - P160045/S025
			Lab Test
			09/29/2023CRCdx(R) RAS Mutation Detection Kit - P220005
			Lab Test
			09/29/2023LimFlowTM System
			Stent
			09/11/2023Boston Scientific Cardiac Cryoablation System and Accessories, consisting of: POLARx Cryoablation Ballon Catheter, POLARx FIT Cryoablation Ballon Catheter, SMARTFREEZE Cryoablation System Console - P220032
			Catheter
			08/08/2023Minitouch 3.8 Era System - P230002
			Endometrial
			07/28/2023PALMAZ MULLINS XD Pulmonary Stent - P220004
			Stent
			07/21/2023CraniSeal Dural Sealant - P220014
			Sutures Sealant
			07/06/2023Optilume BPH Catheter System - P220029
			Prostatic Catheter
			06/30/2023HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads – P200007
			Defibrillator
			06/23/2023SurVeil Drug-Coated Ballon - P210025
			Catheter
			06/16/2023TOPS System – P220002
			Spinal Implant
			06/15/2023Inspire Upper Airway Stimulation - P130008/S090
			Nerve Stimulator
			06/08/2023FoundationOne Liquid CDx (F1 Liquid CDx) - P190032/S010
			Lab Test
			06/08/2023DETOUR System - P220021
			Stent
			06/07/2023Perclose ProStyle Suture-Mediated Closure and Repair System and Perclose ProGlide-Suture Closure Systems - P960043/S118
			Catheter Systems
			06/02/2023LiquiFix FIX8 Laparo Hernia Mesh Fixation Devices - P220024
			Hernia Fixation
			06/02/2023PerClot Polysaccharide Hemostatic System - P210036
			Hemostatic system
			05/19/2023VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) - P130010
			Cardiac Implants
			05/17/2023Tactiflex Ablation Catheter, Sensor Enabled - P220013
			Cardiac catheter
			05/18/2023SKINVIVE by JUVÉDERM – P110033/S059
			Dermal Filler
			05/11/2023Restylane Eyelight – P040024/S135
			Dermal Filler
			05/08/2023REFLECT Scoliosis Correction System - H210002
			Spinal Implant
			05/15/2023FoundationOne Liquid CDx (F1 Liguid CDx) - P190032/S005
			Lab Test
			05/03/2023xT CDx - P210011
			Lab Test
			04/28/2023ADVIA 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/S002
			Lab Test
			04/28/2023Precision7, Precision7 for Astigmatism, Precision7 Multifocal, Precision7 Multifocal Toric (serafilcon A) - P220007
			Contact Lens
			04/25/2023Sculptra - P030050/S039
			Gel Implant
			04/25/2023MiniMed 780G - P160017/S091
			Glucose Monitor
			04/21/2023Lava Liquid Embolic System – P220020
			Vascular Hemorrhage Blocker
			04/04/2023Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management - P210037
			Spinal Stimulator
			03/31/2023NeuRx Diaphragm Pacing System - P200018
			Breathing Stimulator
			03/31/2023Eversense E3 Continuous Glucose Monitoring (CGM) System - P160048/S021
			Glucose Monitor
			03/29/2023Inspire Upper Airway Stimulation - P130008/S089
			Nerve Stimulator
			03/20/2023iCAST Covered Stent System - P120003
			Stent
			03/22/2023RelayPro Thoracic Stent-Graft System - P200045/S002
			Stent
			03/07/2023CALCIVIS Imaging System - P170029
			Syringe Applicator
			03/07/2023VENTANA PD-L1 (SP263) Assay - P160046/S013
			Lab Test
			03/01/2023StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) - P220009
			Cataract surgery
			02/22/2023Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems - P010032/S189
			Spinal Implant
			02/15/2023Guardant360 CDx - P200010/S010
			Lab Test
			01/27/2023AAV5 DetectCDx – P190033
			Lab Test
			06/29/2023

                                                                                  Content current as of:
      01/26/2024
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsRecently-Approved Devices

          
                        2023 Device Approvals
          2022 Device Approvals
          2021 Device Approvals
 
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