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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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161 to 170 of 413 results
Decision Date To: 05/17/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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Acclarent Aera Eustachian Tube Balloon D ACCLARENT, INC. DEN150056 09/16/2016
Sensor Monitored Alimentary Restriction SCIENTIFIC INTAKE DEN150033 09/26/2016
APAS Compact with Urine Analysis Module CLEVER CULTURE SYSTEMS AG DEN150059 10/06/2016
BD MAX Vaginal Panel, BD MAX Instrument GENEOHM SCIENCES CANADA , INC (BD DIAGNO DEN160001 10/28/2016
CleanCisionTM Wound Retraction and Prote Prescient Surgical DEN150038 12/16/2016
Elecsys AMH, AMH CalSet, PreciControl AM ROCHE DIAGNOSTICS DEN150057 12/19/2016
Hem-Avert Perianal Stabilizer STETRIX, INC. DEN160005 12/19/2016
Ultravision Visual Clearing System Alesi Surgical Ltd. DEN150022 12/20/2016
AeroForm Tissue Expander System AIRXPANDERS, INC DEN150055 12/21/2016
CipherOx CRI Tablet Flashback Technologies, Inc. DEN160020 12/21/2016
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