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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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51 to 60 of 413 results
Decision Date To: 05/15/2024
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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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FilmArray NGDS Warrior Panel BioFire Defense, LLC DEN160048 02/14/2017
FilmArray Global Fever Panel BioFire Defense, LLC DEN200043 11/20/2020
FilmArray Meningitis/Encephalitis(ME) Pa BioFire Diagnostics, LLC DEN150013 10/08/2015
FilmArray Respiratory Panel 2 plus (RP2p BioFire Diagnostics, LLC DEN170017 11/24/2017
BioFire Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics, LLC DEN200031 03/17/2021
BioFire Joint Infection (JI) Panel BioFire Diagnostics, LLC DEN200066 04/29/2022
RemeOs™ Screw LAG Solid Bioretec Ltd. DEN220030 03/29/2023
Embosphere Microspheres Biosphere Medical S.A. DEN160040 06/21/2017
Surfacer Inside-Out Access Catheter Syst Bluegrass Vascular Technologies, Inc. DEN190038 02/10/2020
Revi System BlueWind Medical Ltd. DEN220073 08/16/2023
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