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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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11 to 20 of 416 results
Decision Date To: 06/08/2024
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Device Name
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Requester
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De Novo
Number
sort by DeNovo number [0-9]
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510(k)
Number
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Decision
Date
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sort by decision date [9-0]
Notal Vision Home Optical Coherence Tomo Notal Vision Inc DEN230043 05/15/2024
Sleep Apnea Feature Samsung Electronics Co., Ltd DEN230041 02/06/2024
Sepsis ImmunoScore Prenosis, Inc. DEN230036 04/02/2024
DentalMonitoring Dental Monitoring SAS DEN230035 05/17/2024
X100 with Full Field Bone Marrow Aspirat Scopio Labs Ltd. DEN230034 03/22/2024
Symani Surgical System MMI North America, Inc. DEN230032 04/05/2024
NaviCam ProScan Ankon Technologies Co., Ltd DEN230027 12/12/2023
MIRA Surgical System Virtual Incision DEN230025 02/23/2024
Technozym ADAMTS13 Activity Technoclone Herstellung von Diagnostika DEN230024 02/28/2024
Rho 16 Bit Inc DEN230023 04/09/2024
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