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  1. Recently-Approved Devices

The 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 Date
RHA Redensity - P170002/S012 Dermal Filler 12/22/2021
SCOREFLEX NC SCORING PTCA CATHETER - P200041 Catheter 12/21/2021
SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System - P210014 Stent Delivery System 12/13/2021
OrganOx metra® System - P200035 Donor Liver Transport System 12/09/2021
SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly - P200040 Ultrasound 10/06/2021
Exablate Model 4000 Type 1.0 and 1.1 System ("Exablate Neuro") - P150038/S014 Ultrasound 10/29/2021
Oncomine Dx Target Test - P160045/S029 Laboratory Test 09/15/2021
Organ Care System (OCS) Heart System - P180051 Transplant 09/03/2021
Vercise™ PC, Vercise Gevia™ and Vercise Genus™ Deep Brain Stimulation (DBS) System - P150031/S040 Implant 10/20/2021
VENTANA PD-L1 (SP263) Assay - P160046/S010 Laboratory Test 10/15/2021
Spatz3 Adjustable Balloon System - P190012 Implant 10/15/2021
Ki-67 IHC MIB-1 pharmDx (Dako Omnis) - P210026 Laboratory Test 10/12/2021
ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters - P200004 Defibrillator Components 09/26/2021
Organ Care System (OCS) Liver - P200031 Portable Enclosure 09/28/2021
Portico Transcatheter Aortic Valve Implantation System - P190023 Implant 09/17/2021
therascreen KRAS RGQ PCR Kit - P110027/S012 Laboratory Test 05/28/2021
RADIESSE (+) Lidocaine Injectable Implant - P050052/S129 Implant 09/01/2021
ASSURE 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 07/27/2021
Oncomine Dx Target Test - P160045/S028 Laboratory Test 08/25/2021
VENTANA MMR RxDx Panel - P210001 Laboratory Test 08/17/2021
Amplatzer Amulet Left Atrial Appendage Occluder - P200049 Implant 12/22/2021
Patient Specific Talus Spacer - H200001 Implant 02/17/2021
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter - P200039 Catheter 02/12/2021
4Kscore Test - P190022 Laboratory Test 12/07/2021
Optilume® Urethral Drug Coated Balloon - P210020 Drug Coated Balloon 12/03/2021

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