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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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131 to 140 of 429 results
Decision Date To: 05/24/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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Parathyroid Detection (Model PTeye) Syst AiBiomed, Corp. DEN170056 11/02/2018
AeroForm Tissue Expander System AIRXPANDERS, INC DEN150055 12/21/2016
EndeavorRx Akili Interactive Labs Inc. DEN200026 06/15/2020
Kerasave AL.CHI.MI.A. S.r.l DEN200063 05/02/2022
RELIZORB ALCRESTA, INC. DEN150001 11/20/2015
WOUNDCHEK Bacterial Status Alere Scarborough, Inc. DEN180014 12/02/2019
Ultravision Visual Clearing System Alesi Surgical Ltd. DEN150022 12/20/2016
TrueTear Intranasal Tear Neurostimulator Allergan DEN170086 05/17/2018
Hemolung Respiratory Assist System ALung Technologies, Inc. DEN210006 11/13/2021
Parsortix PC1 Device ANGLE Europe Ltd. DEN200062 05/24/2022
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