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
CRCdx(R) RAS Mutation Detection Kit - P220005
Lab Test
09/29/2023
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
Content current as of:
10/19/2023