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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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81 to 90 of 415 results
Decision Date To: 05/22/2024
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Device Name
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510(k)
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Sentosa SQ HIV Genotyping Assay Vela Diagnostics USA Inc BR190330 11/05/2019
Sentinel Cerebral Protection System Claret Medical, Inc. DEN160043 06/01/2017
Sensor Monitored Alimentary Restriction SCIENTIFIC INTAKE DEN150033 09/26/2016
SENSIMED TRIGGERFISH SENSIMED AG DEN140017 03/04/2016
SEM Scanner (Model 200) Bruin Biometrics, LLC DEN170021 12/20/2018
SEEKER System Baebies, Inc. DEN150035 02/03/2017
SeCore CDx HLA Sequencing System One Lambda, Inc. BR220737 11/28/2022
ScanNav Anatomy Peripheral Nerve Block Intelligent Ultrasound Limited DEN220024 10/18/2022
SafeBreak Vascular Site Saver, Inc. d/b/a Lineus Medical DEN190043 05/27/2021
Ruthless Spine RJB Ruthless, LLC dba Ruthless Spine DEN230012 07/14/2023
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