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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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71 to 80 of 413 results
Decision Date To: 05/15/2024
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Download Files | More About De Novo
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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Brainsway Deep Transcranial Magnetic Sti Brainways Ltd. DEN170078 08/17/2018
SEM Scanner (Model 200) Bruin Biometrics, LLC DEN170021 12/20/2018
MALDI Biotyper CA System Bruker Daltonik GmbH DEN170081 04/20/2018
Cala ONE Cala Health, Inc. DEN170028 04/26/2018
Canary Tibial Extension with Canary Heal Canary Medical, Inc. DEN200064 08/27/2021
The N-SWEAT Patch Candesant Biomedical, Inc. DEN210055 04/07/2023
Caption Interpretation Automated Ejectio Caption Health, Inc DEN220063 02/24/2023
AMIGO REMOTE CATHETER SYSTEM CATHETER ROBOTICS INC DEN140009 12/18/2014
Synovasure Alpha Defensin Lateral Flow T CD Diagnostics Inc. DEN180032 05/23/2019
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR CENTERS FOR DISEASE CONTROL AND PREVENTI DEN070001 09/21/2018
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