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                Recently-Approved Devices

Recently-Approved Devices

                        2023 Device Approvals
          2022 Device Approvals
          2021 Device Approvals Home
          Medical Devices
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          Device Approvals, Denials and Clearances
          Recently-Approved Devices
          2021 Device ApprovalsRecently-Approved Devices 2021 Device Approvals
  
  	
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    PrintThe products listed in this section include some of the newest medical technology from the year 2021. 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 2021

Device Name
			Category
			DateRHA Redensity - P170002/S012
			Dermal Filler
			12/22/2021SCOREFLEX NC SCORING PTCA CATHETER - P200041
			Catheter
			12/21/2021SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System - P210014
			Stent Delivery System
			12/13/2021OrganOx metra® System - P200035
			Donor Liver Transport System
			12/09/2021TactiCath Contact Force Ablation Catheter, Sensor Enabled - P130026/S070
			Catheter
			11/23/2021SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly - P200040
			Ultrasound
			10/06/2021Exablate Model 4000 Type 1.0 and 1.1 System ("Exablate Neuro") - P150038/S014
			Ultrasound
			10/29/2021Oncomine Dx Target Test - P160045/S029
			Laboratory Test
			09/15/2021Organ Care System (OCS) Heart System - P180051
			Transplant
			09/03/2021VerciseTM PC, Vercise GeviaTM and Vercise GenusTM Deep Brain Stimulation (DBS) System - P150031/S040
			Implant
			10/20/2021VENTANA PD-L1 (SP263) Assay - P160046/S010
			Laboratory Test
			10/15/2021Spatz3 Adjustable Balloon System - P190012
			Implant
			10/15/2021Ki-67 IHC MIB-1 pharmDx (Dako Omnis) - P210026
			Laboratory Test
			10/12/2021ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters - P200004
			Defibrillator Components
			09/26/2021Organ Care System (OCS) Liver - P200031
			Portable Enclosure
			09/28/2021Portico Transcatheter Aortic Valve Implantation System - P190023
			Implant
			09/17/2021therascreen KRAS RGQ PCR Kit - P110027/S012
			Laboratory Test
			05/28/2021RADIESSE (+) Lidocaine Injectable Implant - P050052/S129
			Implant
			09/01/2021ASSURE Wearable Cardioverter Defibrillator System Kit (P/N 80014-001), Monitor (P/N 80008-003), Therapy Cable (P/N 80004-003), Garment Style A (P/N 80015-XXX*) and Style B (P/N 80016-XXX*), Rechargeable Battery (P/N 3322882-005), Carry Pack (3326503-003), Battery Charger (3326633-004), Tablet (P/N 80041-001) - P200037
			Defibrillator
			07/27/2021Oncomine Dx Target Test - P160045/S028
			Laboratory Test
			08/25/2021VENTANA MMR RxDx Panel - P210001
			Laboratory Test
			08/17/2021Amplatzer Amulet Left Atrial Appendage Occluder - P200049
			Implant
			12/22/2021Agili-C – P210034
			Implant
			03/29/2021Patient Specific Talus Spacer - H200001
			Implant
			02/17/2021Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter - P200039
			Catheter
			02/12/20214Kscore Test - P190022
			Laboratory Test
			12/07/2021Optilume® Urethral Drug Coated Balloon - P210020
			Drug Coated Balloon
			12/03/2021Guardant360 CDx – P200010/S001
			Laboratory Test
			05/21/2021

                                                                                  Content current as of:
      08/01/2022
              
              
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			  Premarket Approval (PMA)Recently-Approved Devices

          
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