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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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131 to 140 of 412 results
Decision Date To: 05/03/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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ELEOSx™ Limb Salvage System Onkos Surgical DEN210058 04/05/2024
SeCore CDx HLA Sequencing System One Lambda, Inc. BR220737 11/28/2022
iTEAR Neurostimulator Olympic Ophthalmics, Inc. DEN190026 05/01/2020
OHMEDA INOVENT DELIVERY SYSTEM OHMEDA MEDICAL DEN000001 K974562 01/11/2000
WIDEXLINK IN CLEAR SERIES HEARING AIDS OFFICE RESEARCH IN CLINICAL AMPLIFICTION DEN100025 K101699 03/31/2011
EyeBOX Oculogica, Inc. DEN170091 12/28/2018
Oculeve Intranasal Tear Neurostimulator OCULEVE, INC. DEN160030 04/24/2017
NUCLEUS-X PTV CATHETER NUMED, INC. DEN080015 K082776 06/11/2012
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
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