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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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311 to 320 of 413 results
Decision Date To: 05/17/2024
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Download Files | More About De Novo
Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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ADVIA Centaur Enhanced Liver Fibrosis (E Siemens Healthcare Diagnostics Inc. DEN190056 08/20/2021
SureTune4 Software Medtronic Neuromodulation DEN210003 08/23/2021
Canary Tibial Extension with Canary Heal Canary Medical, Inc. DEN200064 08/27/2021
FEops HEARTguide FEops NV DEN200030 09/08/2021
Paige Prostate Paige.AI DEN200080 09/21/2021
iotaSOFT Insertion System - Drive Unit, IotaMotion, Inc. DEN190055 10/01/2021
Luminopia One Luminopia, Inc. DEN210005 10/20/2021
OMNIgene GUT Dx DNA Genotek Inc. DEN200040 11/03/2021
Hemolung Respiratory Assist System ALung Technologies, Inc. DEN210006 11/13/2021
EaseVRx AppliedVR, Inc. DEN210014 11/16/2021
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