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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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41 to 50 of 416 results
Decision Date To: 05/31/2024
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Download Files | More About De Novo
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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ZANZA-CLICK TECNIMED S.R.L. DEN130019 11/07/2014
BioTraceIO Lite TechsoMed Medical Technologies Ltd. DEN230020 12/22/2023
Technozym ADAMTS13 Activity Technoclone Herstellung von Diagnostika DEN230024 02/28/2024
LIPFLOW THERMAL PULSATION SYSTEM (FORMER TEARSCIENCE, INC. DEN100017 K093937 06/28/2011
Tangible Boost Tangible Science, Inc. DEN200002 09/24/2020
t:slim X2 insulin pump with interoperabl Tandem Diabetes Care, Inc. DEN180058 02/14/2019
Control-IQ Technology Tandem Diabetes Care, Inc. DEN190034 12/13/2019
T2CANDIDA AND T2DX INSTRUMENT T2 BIOSYSTEMS, INC DEN140019 09/22/2014
Stanza Swing Therapeutics, Inc. DEN220083 05/09/2023
Sunrise Sleep Disorder Diagnostic Aid Sunrise DEN210015 01/07/2022
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