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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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231 to 240 of 476 results
Decision Date To: 04/04/2026
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Device Name
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510(k)
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Decision
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iotaSOFT Insertion System - Drive Unit, Iotamotion, Inc. DEN190055 10/01/2021
IOGYN SYSTEM Iogyn, Inc. DEN130040 K132695 03/28/2014
INVOcell Invo Bioscience DEN150008 11/02/2015
Invitae Common Hereditary Cancers Panel Invitae Corporation DEN210011 09/29/2023
Neoasis Invictus Medical, Inc. DEN220048 06/16/2023
BINAX NOW MALARIA TEST; MODEL 660-000, 6 Inverness Medical Professional Diagnosti DEN070006 K061542 06/13/2007
VerTouch Spinal Imaging Device Intuitap Medical, Inc. DEN220009 01/19/2024
EndoRotor Device Interscope, Inc. DEN200016 12/23/2020
LOADPRO™ Intraoperative Rod Strain Senso Intellirod Spine, Inc. DEN180012 03/28/2019
ScanNav Anatomy Peripheral Nerve Block Intelligent Ultrasound Limited DEN220024 10/18/2022
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