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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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181 to 190 of 413 results
Decision Date To: 05/17/2024
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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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Oculeve Intranasal Tear Neurostimulator OCULEVE, INC. DEN160030 04/24/2017
ARK Voriconazole II Assay Test System ARK DIAGNOSTICS, INC DEN160033 05/05/2017
Vitamin D 200M Assay for the Topaz Syste AB SCIEX LLC DEN170019 05/18/2017
Sentinel Cerebral Protection System Claret Medical, Inc. DEN160043 06/01/2017
Embosphere Microspheres Biosphere Medical S.A. DEN160040 06/21/2017
ClearLLab T1, ClearLLab T2, ClearLLab B1 Beckman Coulter DEN160047 06/29/2017
D2 Dressing Z-MEDICA, LLC DEN160012 06/30/2017
QuantX Quantitative Insights, Inc DEN170022 07/19/2017
FETAL PILLOW SAFE OBSTETRIC SYSTEMS LTD DEN150053 07/27/2017
ID-FISH Plasmodium Genus Test Kit, ID-FI ID-FISH TECHNOLOGY, INC DEN160025 08/18/2017
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