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  6. 2024 Device Approvals
  1. Recently-Approved Devices

2024 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2024. 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 2024

Device NameCategoryDate
VARIPULSE Platform (VARIPULSE Catheter; TRIPULSE Generator; Sterile Interface Cable; nGEN Pump) - P240006Catheter11/06/2024
Sphere-9 Catheter and Affera Ablation System - P240013Catheter10/24/2024
Oncomine Dx Target Test - P160045/S046Lab Test10/17/2024
Neuroguard IEP®  System - P240009 Catheter10/11/2024
Minima Stent System - P240003Stent08/28/2024
Altius Direct Electrical Nerve Stimulation System - P230020Stimulation System08/26/2024
Shield - P230009Lab Test07/26/2024
UNIPURE C3F8 Ophthalmic Gas, UNIFEYE Gas Delivery System, UNIPEXY Gas Delivery System - P220030Eye Injection07/02/2024
MYNX CONTROL Venous Vascular Closure Device (VCD) 6F-12F - P040044/S097Vascular Closure Delivery System06/27/2024
Abbott Spinal Cord Stimulation (SCS) Systems - P010032/S191Stimulator05/30/2024
Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System - P140031/S162Heart Valve05/23/2024
BD Onclarity HPV Assay - P160037/S017Lab Test05/14/2024
cobas HPV Test for 4800 System - P100020/S055Lab Test05/14/2024
cobas HPV for 5800/6800/8800 Systems - P190028/S009Lab Test05/14/2024
ColoSense - P230001Lab Test05/03/2024
nAbCyte Anti-AAVRh74var HB-FE Assay - H230005Lab Test04/25/2024
Esprit BTK Everolimus Eluting Resorbable Scaffold System - P230036Catheter04/26/2024
Lumicell Direct Visualization Systems (DVS) - P230014Imaging Device04/17/2024
GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) - P200030/S014Stent04/05/2024
TriClip G4 System - P230007Heart Clip Implant04/01/2024
LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus - P220034Lab Test03/29/2024
AGENT Paclitaxel-Coated Ballon Catheter - P230035Catheter02/29/2024
Vercise PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation (DBS) System - P150031/S064Stimulation System02/29/2024
INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on the RHYTHMIA HDX Mapping System - P150005/S074Catheter02/26/2024
Xstim Spine Fusion Stimulator - P230025Stimulator02/09/2024
XACT Carotid Stent System - P040038/S043Stent02/07/2024
Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS Spinal Cord Stimulation Systems - P030017/S363Stimulation System02/05/2024
Edwards EVOQUE Tricuspid Valve Replacement System - P230013Tricuspid Valve Replacement System02/01/2024
PyloPlus UBT System - P170022/S003Lab Test01/11/2024
TZ Medical Adult and Pediatric Multi-Function Defibrillation Electrodes and Adaptors - P200005Defibrillator01/09/2024
TruSight Oncology Comprehensive - P230011Laboratory Test08/21/2024
Simplera system - P160007/S047Continuous Glucose Monitoring System07/24/2024
UNIPURE SF6 Ophthalmic Gas UNIFEYE Gas Delivery System and UNIPURE SF6 Ophthalmic Gas UNIPEXY Gas Delivery System - P230012Eye Injection08/26/2024

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