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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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31 to 40 of 412 results
Decision Date To: 05/02/2024
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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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VERIFY CRONOS SELF-CONTAINED BIOLOGICAL STERIS Corporation DEN110006 K102469 07/12/2013
VERICHIP HEALTH INFORMATION MICROTRANSPO DIGITAL ANGEL CORPORATION DEN040007 K033440 10/12/2004
VENTANA anti-MLH-1(M1) Mouse Monoclonal Ventana Medical Systems DEN170030 10/27/2017
VasQ Laminate Medical Technologies Ltd. DEN220026 09/26/2023
Variola virus Real-Time PCR Assay CENTERS FOR DISEASE CONTROL AND PREVENTI DEN160016 02/06/2017
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE UROSURGE, INC. DEN000002 K992069 02/09/2000
UROLIFT SYSTEM NEOTRACT, INC. DEN130023 K130651 09/13/2013
Ultravision Visual Clearing System Alesi Surgical Ltd. DEN150022 12/20/2016
ULTHERA SYSTEM, MODEL 8850-0001 ULTHERA, INC. DEN080006 K072505 09/11/2009
TrueTear Intranasal Tear Neurostimulator Allergan DEN170086 05/17/2018
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