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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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91 to 100 of 416 results
Decision Date To: 06/08/2024
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Download Files | More About De Novo
Device Name
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De Novo
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510(k)
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FERRISCAN R2-MRI ANALYSIS SYSTEM RESONANCE HEALTH ANALYSIS SERVICES PTY L DEN130012 K124065 01/23/2013
KidneyIntelX.dkd Renalytix AI, Inc. DEN200052 06/29/2023
RefleXion Medical Radiotherapy System (R RefleXion Medical Inc DEN220014 02/01/2023
PEDIATRIC VISION SCANNER REBISCAN, INC. DEN130051 06/08/2016
Comaneci, Comaneci Petit, Comaneci 17 Rapid-Medical Ltd. DEN170064 04/24/2019
BraidE Embolization Assist Device Rapid Medical Ltd. DEN230064 02/21/2024
PROSTATE IMMOBILIZER RECTAL BALLOON RADIADYNE DEN130036 K132194 01/28/2014
RIDASCREEN NOROVIRUS 3RD GENERATION EIA R-Biopharm AG DEN110001 K093295 02/23/2011
LYRA DIRECT STREP ASSAY QUIDEL CORPORATION DEN140005 K133883 04/16/2014
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Quidel Corporation DEN220039 03/08/2023
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