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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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81 to 90 of 413 results
Decision Date To: 05/15/2024
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Device Name
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Variola virus Real-Time PCR Assay CENTERS FOR DISEASE CONTROL AND PREVENTI DEN160016 02/06/2017
COGNIVUE CEREBRAL ASSESSMENT SYSTEMS, INC DEN130033 06/05/2015
Cereve Sleep System CEREVE, INC. DEN140032 05/13/2016
Sentinel Cerebral Protection System Claret Medical, Inc. DEN160043 06/01/2017
APAS Compact with Urine Analysis Module CLEVER CULTURE SYSTEMS AG DEN150059 10/06/2016
Cognoa ASD Diagnosis Aid Cognoa, Inc. DEN200069 06/02/2021
Modified Trevo ProVue Retriever, Trevo X CONCENTRIC MEDICAL, INC. DEN150049 09/02/2016
Gili Pro BioSensor (also known as “Gili ContinUse Biometrics Ltd. DEN200038 04/01/2021
Retrograde Intubation Set Cook Incorporated DEN170055 12/12/2018
EchoTip Insight Portosystemic Pressure G Cook Ireland Ltd. DEN180062 11/20/2019
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