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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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131 to 140 of 413 results
Decision Date To: 05/17/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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HemosIL Liquid Anti-Xa Instrumentation Laboratory Co. DEN190032 09/17/2020
Theranova Dialyzers, Theranova 400 Dialy Baxter Healthcare Corporation DEN190042 08/28/2020
Cell-Free DNA BCT Streck, Inc. DEN200001 08/07/2020
cobas EBV, cobas EBV/BKV Control Kit, co Roche Molecular Systems, Inc. DEN200015 07/30/2020
EndeavorRx Akili Interactive Labs Inc. DEN200026 06/15/2020
NaviCam Capsule Endoscope System with Na AnX Robotica, Inc. DEN190037 05/22/2020
NP Screen Advance Sentry Corporation DEN190031 05/11/2020
iTEAR Neurostimulator Olympic Ophthalmics, Inc. DEN190026 05/01/2020
OGmend Implant System Woven Orthopedic Technologies, LLC DEN180065 05/01/2020
CARPEDIEM System Bellco srl (now part of Medtronic, Inc) DEN180055 04/29/2020
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