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  1. Recently-Approved Devices

The products listed in this section include some of the newest medical technology from the year 2020. 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 2020

 

Device Name Category Date
LIAISON XL MUREX HBsAg Confirmatory test, LIAISON® XL MUREX Control HBsAg, LIAISON® XL MUREX Qual HBsAg – P190017 HBsAg Confirmatory Test 08/29/20
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System - P200015 Heart Valve 08/31/20
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg Laboratory Test 08/29/20
LIAISON® XL MUREX HBc IgM, LIAISON® MUREX Control HBc IgM – P180045 Laboratory Test 08/29/20
Alinity m HBV – P200013 Laboratory Test 08/29/20
LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe – P180049 Laboratory Test 08/29/20
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) – P15003/S058 Stent 08/11/20
Kendall™ Multifunction Defibrillation Electrodes - P190007 Automated External Defibrillator (AED) 08/07/20
Guardant360 CDx – P200010 Laboratory Test 08/07/20
Neuroform Atlas® Stent System - P180031/S001 Stent 07/30/20
VENTANA HER2 Dual ISH DNA Probe Cocktail – P190031 Laboratory Test 07/28/20
WATCHMAN Left Atrial Appendage Closure Device with Delivery System and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System - P130013/S035 Stent 07/21/20
The Arctic Front Advance™ and Arctic Front Advance Pro™ and The Freezor Max™ Cardiac Cryoablation Catheters - P100010/S098 Catheter 06/23/20
cobas® EZH2 Mutation Test - P200014 Laboratory Test 06/18/20
Reactiv8 Implantable Neurostimulation System - P190021 Implantable Neurostimulation System 06/16/20
FoundationOne®CDx - P170019/S016 Laboratory Test 06/16/20
JUVÉDERM® VOLUMA™ XC - P110033/S047 Dermal Filler 06/12/20
PD-L1 IHC 28-8 pharmDx - P150025/S013 Laboratory Test 06/08/20
FoundationOne CDx - P170019/S015 Laboratory Test 05/19/20
HeartStart FRx Defibrillator (861304), Primary Battery (Model M5070A), Aviation FRx Battery (989803139301), SMART Pads II (Model 989803139261), and Infant/Child Key (Model 989803139311) - P180028 Automated External Defibrillator (AED) 05/11/20
Philips HeartStart FR3 Defibrillator, Primary Battery, Rechargeable Battery, Charger for the Rechargeable Battery, SmartPads III, DP pads, and Pediatric Key - P160028 Automated External Defibrillator (AED) 05/11/20
FoundationOne CDx - P170019/S011 Laboratory Test 05/06/20
TREO® Abdominal Stent-Graft System - P190015 Stent 05/04/20
FoundationOne CDx - P170019/S013 Laboratory Test 04/17/20
The therascreen® BRAF V600E RGQ PCR Kit - P190026 Laboratory Test 04/15/20
Inspire® Upper Airway Stimulation – P130008/S039 Implantable Nerve Stimulator 04/14/20
Tack Endovascular System® (4F, 1.5-4.5mm) - P190027 Vascular Patch 04/10/20
The prodisc® L Total Disc Replacement - P050010/S020 Disc Replacement 04/10/20
The cobas HPV for use on the cobas 6800/8800 Systems - P190028 Laboratory Test 04/03/20
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs, LIAISON® XL MUREX Anti-HBs Verifiers - P180039 Hepatitis B (HBV) 03/18/20
VENOUS WALLSTENT - P980033/S050 Stent 03/17/20
Nucleus 24 Cochlear Implant System - P970051/S172 Cochlear Implant 03/17/20
Alto™ Abdominal Stent Graft System – P120006/S031 Stent 03/13/20
Ventana Medical Systems CINtec PLUS Cytology - P190024 Laboratory Test 03/10/20
AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL) (Model DFT015), AcrySof™ IQ Vivity™ Toric Extended Vision IOLs (DFT315, DFT415, DFT515), AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL (DAT015), and AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515) - P930014/S126 Intraocular Lens (IOL) 02/26/20
Bulkamid Urethral Bulking System - P170023 Incontinence 02/14/20
Flow Re-Direction Endoluminal Device (FRED®) System - P180027 Stent 01/22/20
Abbott InfinityTM DBS Neurostimulation System – P140009/Abbott InfinityTM DBS Neurostimulation System - P140009/S039 Neurostimulation System 01/20/20
LIAISON® XL MUREX Anti-HBc, LIAISON® XL MUREX Control Anti-HBc - P180038 Blood Assay 01/02/20

 

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