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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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1 to 10 of 412 results
Decision Date To: 05/02/2024
 
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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]
Rho 16 Bit Inc DEN230023 04/09/2024
Symani Surgical System MMI North America, Inc. DEN230032 04/05/2024
ELEOSx™ Limb Salvage System Onkos Surgical DEN210058 04/05/2024
Orthobond Mariner Pedicle Screw System Orthobond Coporation DEN220015 04/05/2024
Sepsis ImmunoScore Prenosis, Inc. DEN230036 04/02/2024
Medline ART Skin Harvesting System Medline Industries, Inc DEN210049 03/27/2024
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
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