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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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341 to 350 of 416 results
Decision Date To: 06/08/2024
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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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INNOVANCE VWF Ac Siemens Healthcare Diagnostics Products DEN200067 09/29/2022
The Cooral System BrainCool AB DEN210027 10/14/2022
ScanNav Anatomy Peripheral Nerve Block Intelligent Ultrasound Limited DEN220024 10/18/2022
Eonis SCID-SMA Kit PerkinElmer Inc. DEN200044 11/09/2022
SeCore CDx HLA Sequencing System One Lambda, Inc. BR220737 11/28/2022
Tornier Pyrocarbon Humeral Head Tornier SAS DEN220012 12/16/2022
BioXmark Nanovi A/S DEN220017 12/23/2022
RefleXion Medical Radiotherapy System (R RefleXion Medical Inc DEN220014 02/01/2023
Active Anthrax DetectTM Plus Rapid Test InBios International, Inc. DEN220044 02/03/2023
PMD-200 Medasense Biometrics Ltd. DEN210022 02/17/2023
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