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  6. 2023 Device Approvals
  1. Recently-Approved Devices

2023 Device Approvals

The 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 Date
Duo Venous Stent System - P230021 Stent 12/26/2023
restor3d Total Talus Replacement - H230003 Implant 11/17/2023
Paradise Ultrasound Renal Denervation System - P220023 Nerve Generator 11/07/2023
RHA 3 dermal filler - P170002/S030 Dermal Filler 10/27/2023
Aurora EV-ICD System - P220012 Heart Monitor 10/20/2023
FoundationOne Liquid CDx (F1 Liguid CDx) - P190032/S011 Lab Test 10/11/2023
OncomineTM Dx Target Test - P160045/S025 Lab Test 09/29/2023
CRCdx(R) RAS Mutation Detection Kit - P220005 Lab Test 09/29/2023
Belotero Balance ®    (+) - P090016/S050 Dermal Filler 09/27/2023
LimFlowTM System Stent 09/11/2023
Boston Scientific Cardiac Cryoablation System and Accessories, consisting of: POLARx Cryoablation Ballon Catheter, POLARx FIT Cryoablation Ballon Catheter, SMARTFREEZE Cryoablation System Console - P220032 Catheter 08/08/2023
Minitouch 3.8 Era System - P230002 Endometrial 07/28/2023
PALMAZ MULLINS XD Pulmonary Stent - P220004 Stent 07/21/2023
CraniSeal Dural Sealant - P220014 Sutures Sealant 07/06/2023
Optilume BPH Catheter System - P220029 Prostatic Catheter  06/30/2023
HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads – P200007 Defibrillator 06/23/2023
SurVeil Drug-Coated Ballon - P210025 Catheter 06/16/2023
TOPS System – P220002 Spinal Implant 06/15/2023
Inspire Upper Airway Stimulation - P130008/S090 Nerve Stimulator 06/08/2023
FoundationOne Liquid CDx (F1 Liquid CDx) - P190032/S010 Lab Test 06/08/2023
DETOUR System - P220021 Stent 06/07/2023
Perclose ProStyle Suture-Mediated Closure and Repair System and Perclose ProGlide-Suture Closure Systems - P960043/S118 Catheter Systems 06/02/2023
LiquiFix FIX8 Laparo Hernia Mesh Fixation Devices - P220024 Hernia Fixation 06/02/2023
PerClot Polysaccharide Hemostatic System - P210036 Hemostatic system 05/19/2023
VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) - P130010 Cardiac Implants 05/17/2023
Tactiflex Ablation Catheter, Sensor Enabled - P220013 Cardiac catheter  05/18/2023
SKINVIVE by JUVÉDERM – P110033/S059 Dermal Filler 05/11/2023
Restylane Eyelight – P040024/S135 Dermal Filler 05/08/2023
REFLECT Scoliosis Correction System - H210002 Spinal Implant 05/15/2023
FoundationOne Liquid CDx (F1 Liguid CDx) - P190032/S005 Lab Test 05/03/2023
xT CDx - P210011 Lab Test 04/28/2023
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/S002 Lab Test 04/28/2023
Precision7, Precision7 for Astigmatism, Precision7 Multifocal, Precision7 Multifocal Toric (serafilcon A) - P220007 Contact Lens 04/25/2023
Sculptra - P030050/S039 Gel Implant 04/25/2023
MiniMed 780G - P160017/S091 Glucose Monitor 04/21/2023
Lava Liquid Embolic System – P220020 Vascular Hemorrhage Blocker 04/04/2023
Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management - P210037 Spinal Stimulator 03/31/2023
NeuRx Diaphragm Pacing System - P200018 Breathing Stimulator 03/31/2023
Eversense E3 Continuous Glucose Monitoring (CGM) System - P160048/S021 Glucose Monitor 03/29/2023
Inspire Upper Airway Stimulation - P130008/S089 Nerve Stimulator 03/20/2023
iCAST Covered Stent System - P120003 Stent 03/22/2023
RelayPro Thoracic Stent-Graft System - P200045/S002 Stent 03/07/2023
CALCIVIS Imaging System - P170029 Syringe Applicator 03/07/2023
VENTANA PD-L1 (SP263) Assay - P160046/S013 Lab Test 03/01/2023
StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) - P220009 Cataract surgery 02/22/2023
Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems - P010032/S189 Spinal Implant 02/15/2023
Guardant360 CDx - P200010/S010 Lab Test 01/27/2023
AAV5 DetectCDx – P190033 Lab Test 06/29/2023

 

 

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