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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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381 to 390 of 475 results
Decision Date To: 01/09/2026
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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)
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Decision
Date
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sort by decision date [9-0]
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC Eneura Therapeutics DEN130022 K130556 12/13/2013
ILLUMINA MISEQDX PLATFORM Illumina, Inc. DEN130011 K123989 11/19/2013
MISEQDX UNIVERSAL KIT 1.0 Illumina, Inc. DEN130042 K133136 11/19/2013
UROLIFT SYSTEM Neotract, Inc. DEN130023 K130651 09/13/2013
VITEK MS bioMerieux, Inc. DEN130013 K124067 08/21/2013
QUANTITATION OF ORGANOPHOSPHATE METABOL Centers for Disease Control and Preventi DEN130005 K122282 08/08/2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN Abbott Molecular, Inc. DEN130010 K123951 07/29/2013
XPERT MTB/RIF ASSAY Cepheid DEN130032 K131706 07/25/2013
NEBA SYSTEM Lexicor Medical Technology, LLC DEN110019 K112711 07/15/2013
CABOCHON SYSTEM Cabochon Aesthetics, Inc. DEN110004 K101231 07/12/2013
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