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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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81 to 90 of 416 results
Decision Date To: 06/01/2024
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Device Name
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510(k)
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Decision
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Zuno Smart Sterilization Container Zuno Medical, Inc. DEN210004 06/17/2022
ProdiGI Covidien LLC DEN220006 06/13/2022
Parsortix PC1 Device ANGLE Europe Ltd. DEN200062 05/24/2022
Quell-FM NeuroMetrix, Inc. DEN210046 05/18/2022
CERAMENT G BoneSupport AB DEN210044 05/17/2022
Lumipulse G ß-Amyloid Ratio (1-42/1-40) Fujirebio Diagnostics, Inc. DEN200072 05/04/2022
Kerasave AL.CHI.MI.A. S.r.l DEN200063 05/02/2022
BioFire Joint Infection (JI) Panel BioFire Diagnostics, LLC DEN200066 04/29/2022
BrainTemp Neonate System (BTNeo System) Brain Temp Inc. DEN200042 03/29/2022
ONE Male Condom Global Protection Corp. DEN210034 02/23/2022
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