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  1. Recently-Approved Devices

2021 Device Approvals

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
Vercise™ PC, Vercise Gevia™ and Vercise Genus™ Deep Brain Stimulation (DBS) System - P150031/S040 Implant 10/20/2021
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
therascreen KRAS RGQ PCR Kit - P110027/S012 Laboratory Test 09/09/2021
RADIESSE (+) Lidocaine Injectable Implant - P050052/S129 Dermal Filler 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 08/26/2021
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 08/14/2021
RelayPro Thoracic Stent-Graft System - P200045 Stent System 08/05/2021
Senza Spinal Cord Stimulation System - P130022/S039 Implant 07/16/2021
FoundationOne Liquid CDx - P190032/S001 Laboratory Test 07/15/2021
Centaur Anti-HBe2 - P200017 Laboratory Test 07/14/2021
Restylane® Contour - P140029/S032 Gel Implant 06/28/2021
XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent Systems (XIENCE Sierra EECSS), XIENCE Skypoint Everolimus Eluting Coronary Stent Systems (XIENCE Skypoint EECSS) - P110019/S115  Stent System 06/25/2021
Neuro Cochlear Implant System - P200021 Implant 06/23/2021
The Arctic Front Advance and Arctic Front Advance Pro and The Freezor MAX Cardiac Cryoablation Catheters - P100010/S110 Catheter 06/18/2021
Guardant360 CDx - P200010/S002 Laboratory Test 05/28/2021
JUVÉDERM® VOLBELLA® XC - P110033/S053 Gel Implant 05/28/2021
Guardant360 CDx - P200010/S001 Laboratory Test 05/21/2021
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S125 Heart Valve 05/13/2021
TECNIS Synergy™ Intraocular Lens (IOL) (Model ZFR00V), TECNIS Synergy™ Toric II IOL (Models ZFW150, ZFW225, ZFW300, ZFW375), TECNIS Synergy™ IOL with TECNIS Simplicity™ Delivery System (Model DFR00V), TECNIS Synergy™ Toric II IOL with TECNIS Simplicity™ Delivery System (Models DFW150, DFW225, DFW300, DFW375) - P980040/S124 Intraocular Lens (IOL) 04/28/2021
EPi-Sense® Guided Coagulation System - P200002 Guided Coagulation System 04/28/2021
VENTANA MMR RxDx Panel - P200019 Laboratory Test 04/22/2021
Simplify® Cervical Artificial Disc - P200022/S003 Implant 04/01/2021
Medtronic Harmony Transcatheter Pulmonary Valve (TPV) System - P200046 Catheter 03/26/2021
ClearVisc Ophthalmic Viscosurgical Device - P200025 Ophthalmic Device 03/23/2021
TheraSphere™ - P200029 Radiation Treatment 03/17/2021
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBsCalCheck - P190034 Laboratory Test 02/23/2021
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
XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent Systems (XIENCE Sierra EECSS), XIENCE Skypoint Everolimus Eluting Coronary Stent Systems (XIENCE Skypoint EECSS) - P110019/S115  Stent System 06/25/2021
Neuro Cochlear Implant System - P200021 Implant 08/25/2021

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