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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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21 to 30 of 412 results
Decision Date To: 05/02/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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Viz HCM Viz.ai, Inc. DEN230003 08/03/2023
VITROS Immunodiagnostic Products Anti-SA Ortho-Clinical Diagnostics, Inc. DEN210040 05/05/2023
VITROS Immunodiagnostic Products Anti-SA Ortho-Clinical Diagnostics, Inc. DEN210038 05/05/2023
VITEK MS BIOMERIEUX, INC. DEN130013 K124067 08/21/2013
Vitamin D 200M Assay for the Topaz Syste AB SCIEX LLC DEN170019 05/18/2017
VIRULITE COLD SORE MACHINE VIRULITE LLC DEN090012 K083767 10/18/2012
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL VIOGUARD DEN100013 K092996 12/20/2011
Vibrant System Vibrant Ltd. DEN210052 08/26/2022
VerTouch Spinal Imaging Device IntuiTap Medical, Inc. DEN220009 01/19/2024
VERIGENE GRAM POSITIVE BLOOD CULTURE NUC NANOSPHERE, INC DEN120014 K113450 06/26/2012
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