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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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191 to 200 of 412 results
Decision Date To: 05/04/2024
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Download Files | More About De Novo
Device Name
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De Novo
Number
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510(k)
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Decision
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IOGYN SYSTEM IOGYN, INC. DEN130040 K132695 03/28/2014
iotaSOFT Insertion System - Drive Unit, IotaMotion, Inc. DEN190055 10/01/2021
ipsogen JAK2 RGQ PCR Kit QIAGEN INC DEN160028 03/27/2017
Irregular Rhythm Notification Feature Apple Inc DEN180042 09/11/2018
iTEAR Neurostimulator Olympic Ophthalmics, Inc. DEN190026 05/01/2020
iTind System Medi-Tate Ltd. DEN190020 02/25/2020
KAVO DIAGNODENT KAVO AMERICA DEN990002 K983658 02/22/2000
Kerasave AL.CHI.MI.A. S.r.l DEN200063 05/02/2022
KidneyIntelX.dkd Renalytix AI, Inc. DEN200052 06/29/2023
Klox Biophotonic LumiHeal System Klox Technlogies Inc. DEN200005 12/03/2021
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