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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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101 to 110 of 416 results
Decision Date To: 06/01/2024
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Device Name
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De Novo
Number
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510(k)
Number
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Decision
Date
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iotaSOFT Insertion System - Drive Unit, IotaMotion, Inc. DEN190055 10/01/2021
Paige Prostate Paige.AI DEN200080 09/21/2021
FEops HEARTguide FEops NV DEN200030 09/08/2021
Canary Tibial Extension with Canary Heal Canary Medical, Inc. DEN200064 08/27/2021
SureTune4 Software Medtronic Neuromodulation DEN210003 08/23/2021
ADVIA Centaur Enhanced Liver Fibrosis (E Siemens Healthcare Diagnostics Inc. DEN190056 08/20/2021
OsteoProbe Active Life Scientific, Inc. DEN210013 08/19/2021
InSpace Subacromial Tissue Spacer System Ortho-Space Ltd. DEN200039 07/12/2021
Cognoa ASD Diagnosis Aid Cognoa, Inc. DEN200069 06/02/2021
SafeBreak Vascular Site Saver, Inc. d/b/a Lineus Medical DEN190043 05/27/2021
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