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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 416 results
Decision Date To: 06/07/2024
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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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Tornier Pyrocarbon Humeral Head Tornier SAS DEN220012 12/16/2022
SeCore CDx HLA Sequencing System One Lambda, Inc. BR220737 11/28/2022
Eonis SCID-SMA Kit PerkinElmer Inc. DEN200044 11/09/2022
ScanNav Anatomy Peripheral Nerve Block Intelligent Ultrasound Limited DEN220024 10/18/2022
The Cooral System BrainCool AB DEN210027 10/14/2022
INNOVANCE VWF Ac Siemens Healthcare Diagnostics Products DEN200067 09/29/2022
Phagenyx System Phagenesis Limited DEN220025 09/16/2022
Vibrant System Vibrant Ltd. DEN210052 08/26/2022
AccuMeasure System RQMIS Inc. DEN210032 07/26/2022
APOLLO ESG System, APOLLO ESG SX System, Apollo Endosurgery, Inc. DEN210045 07/12/2022
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