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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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121 to 130 of 417 results
Decision Date To: 06/21/2024
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Device Name
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De Novo
Number
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510(k)
Number
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Decision
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ECLIPSE SYSTEM PELVALON DEN140020 02/12/2015
Edison System HistoSonics, Inc. DEN220087 10/06/2023
EEVA 2.0 AUXOGYN, INC. DEN120015 K120427 06/06/2014
Elecsys AMH, AMH CalSet, PreciControl AM ROCHE DIAGNOSTICS DEN150057 12/19/2016
ELEOSx™ Limb Salvage System Onkos Surgical DEN210058 04/05/2024
Ellipsys Vascular Access System Avenu Medical, Inc DEN170004 06/22/2018
Embosphere Microspheres Biosphere Medical S.A. DEN160040 06/21/2017
EndeavorRx Akili Interactive Labs Inc. DEN200026 06/15/2020
EndoRotor Device Interscope, Inc DEN200016 12/23/2020
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE SPECTRAL DIAGNOSTICS, INC. DEN030002 K021885 06/16/2003
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