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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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331 to 340 of 416 results
Decision Date To: 06/01/2024
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Device Name
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De Novo
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510(k)
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Decision
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Lumipulse G ß-Amyloid Ratio (1-42/1-40) Fujirebio Diagnostics, Inc. DEN200072 05/04/2022
CERAMENT G BoneSupport AB DEN210044 05/17/2022
Quell-FM NeuroMetrix, Inc. DEN210046 05/18/2022
Parsortix PC1 Device ANGLE Europe Ltd. DEN200062 05/24/2022
ProdiGI Covidien LLC DEN220006 06/13/2022
Zuno Smart Sterilization Container Zuno Medical, Inc. DEN210004 06/17/2022
APOLLO ESG System, APOLLO ESG SX System, Apollo Endosurgery, Inc. DEN210045 07/12/2022
AccuMeasure System RQMIS Inc. DEN210032 07/26/2022
Vibrant System Vibrant Ltd. DEN210052 08/26/2022
Phagenyx System Phagenesis Limited DEN220025 09/16/2022
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