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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 416 results
Decision Date To: 06/08/2024
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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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Comaneci, Comaneci Petit, Comaneci 17 Rapid-Medical Ltd. DEN170064 04/24/2019
PREVENA 125 and PREVENA PLUS 125 Therapy KCI USA, Inc. DEN180013 04/19/2019
Monarch eTNS System NeuroSigma, Inc DEN180041 04/19/2019
Plenity Gelesis, Inc. DEN180060 04/12/2019
LOADPRO™ Intraoperative Rod Strain Senso Intellirod Spine, Inc. DEN180012 03/28/2019
Leica FL400 Leica Microsystems (Schweiz) AG DEN180024 03/28/2019
ClearMate Thornhill Research, Inc. DEN170044 03/14/2019
Quantra Hemostasis Analyzer, QPlus Cartr HemoSonics, LLC DEN180017 03/12/2019
Early Bird Bleed Monitoring System Saranas, Inc. DEN180021 03/01/2019
t:slim X2 insulin pump with interoperabl Tandem Diabetes Care, Inc. DEN180058 02/14/2019
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