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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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251 to 260 of 412 results
Decision Date To: 05/03/2024
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Device Name
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De Novo
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510(k)
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Decision
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LOADPRO™ Intraoperative Rod Strain Senso Intellirod Spine, Inc. DEN180012 03/28/2019
Leica FL400 Leica Microsystems (Schweiz) AG DEN180024 03/28/2019
Plenity Gelesis, Inc. DEN180060 04/12/2019
PREVENA 125 and PREVENA PLUS 125 Therapy KCI USA, Inc. DEN180013 04/19/2019
Monarch eTNS System NeuroSigma, Inc DEN180041 04/19/2019
Comaneci, Comaneci Petit, Comaneci 17 Rapid-Medical Ltd. DEN170064 04/24/2019
Nerivio Migra Theranica Bioelectronics ltd DEN180059 05/20/2019
Synovasure Alpha Defensin Lateral Flow T CD Diagnostics Inc. DEN180032 05/23/2019
ZIKV Detect 2.0 IgM Capture ELISA InBios International, Inc. DEN180069 05/23/2019
IB-Stim Innovative Health Solutions (IHS), Inc. DEN180057 06/07/2019
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