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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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141 to 150 of 416 results
Decision Date To: 06/01/2024
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Device Name
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510(k)
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NTX100 Tonic Motor Activation (NTX100 To Noctrix Health, Inc. DEN220059 04/17/2023
NightWare Kit, Apple iPhone, Apple Watch NightWare, Inc DEN200033 11/06/2020
Monarch eTNS System NeuroSigma, Inc DEN180041 04/19/2019
NEUROSTAR TMS SYSTEM NEURONETICS DEN070003 K061053 10/07/2008
Lenire Tinnitus Treatment Device Neuromod Devices Limited DEN210033 03/06/2023
Quell-FM NeuroMetrix, Inc. DEN210046 05/18/2022
Neurolutions Upper Extremity Rehabilitat Neurolutions, Inc. DEN200046 04/23/2021
UROLIFT SYSTEM NEOTRACT, INC. DEN130023 K130651 09/13/2013
Natural Cycles Natural Cycles Nordic AB DEN170052 08/10/2018
AHIP INTERNAL TRIGGER POINT WAND MODEL: NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEN100023 K100934 11/20/2012
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