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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: 06/01/2024
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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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X100 with Full Field Bone Marrow Aspirat Scopio Labs Ltd. DEN230034 03/22/2024
Technozym ADAMTS13 Activity Technoclone Herstellung von Diagnostika DEN230024 02/28/2024
MIRA Surgical System Virtual Incision DEN230025 02/23/2024
BraidE Embolization Assist Device Rapid Medical Ltd. DEN230064 02/21/2024
Sleep Apnea Feature Samsung Electronics Co., Ltd DEN230041 02/06/2024
“Genius™ Digital Diagnostics System with Hologic Inc. DEN210035 01/31/2024
VerTouch Spinal Imaging Device IntuiTap Medical, Inc. DEN220009 01/19/2024
Osteoboost Belt Bone Health Technologies, Inc DEN230015 01/12/2024
DermaSensor DermaSensor Inc. DEN230008 01/12/2024
Fibresolve Imvaria, Inc DEN220040 01/12/2024
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