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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 412 results
Decision Date To: 04/19/2024
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Download Files | More About De Novo
Device Name
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De Novo
Number
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510(k)
Number
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Decision
Date
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TrueGene HIV Genotyping Kit and OpenGene Visible Genetics, Inc. BK000038 06/27/2001
Tristel Duo ULT Tristel Solutions Limited DEN220041 06/02/2023
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) BIOSITE INCORPORATED DEN000010 K003475 11/20/2000
Tornier Pyrocarbon Humeral Head Tornier SAS DEN220012 12/16/2022
ToothWave™ Home Skinovations Ltd. DEN190039 09/17/2020
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM Roche Diagnostics DEN130002 K121291 05/23/2013
ThermoNeuroModulation Device, TNM Device Scion NeuroStim, LLC DEN170023 03/26/2018
Theranova Dialyzers, Theranova 400 Dialy Baxter Healthcare Corporation DEN190042 08/28/2020
The N-SWEAT Patch Candesant Biomedical, Inc. DEN210055 04/07/2023
The Cooral System BrainCool AB DEN210027 10/14/2022
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