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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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111 to 120 of 412 results
Decision Date To: 05/03/2024
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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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Oxehealth Vital Signs Oxehealth Limited DEN200019 03/26/2021
BioFire Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics, LLC DEN200031 03/17/2021
ClearUP Sinus Relief Tivic Health Systems Inc. DEN200006 03/05/2021
Analytic for Hemodynamic Instability (AH Fifth Eye Inc. DEN200022 03/01/2021
Hominis Surgical System Memic Innovative Surgery Ltd. DEN190022 02/26/2021
Q-Collar Q30 Sports Science, LLC DEN200017 02/26/2021
Lumenis Stellar M22 Lumenis Ltd. DEN200028 02/23/2021
eXciteOSA with remote and eXciteOSA with Signifier Medical Technologies DEN200018 02/05/2021
Helix Laboratory Platform Helix OpCo, LLC DEN190035 12/23/2020
EndoRotor Device Interscope, Inc DEN200016 12/23/2020
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