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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 416 results
Decision Date To: 06/01/2024
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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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Tristel Duo ULT Tristel Solutions Limited DEN220041 06/02/2023
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test Sy BRAHMS GmbH, Part of Thermo Fisher Scien DEN220027 05/18/2023
Stanza Swing Therapeutics, Inc. DEN220083 05/09/2023
VITROS Immunodiagnostic Products Anti-SA Ortho-Clinical Diagnostics, Inc. DEN210038 05/05/2023
VITROS Immunodiagnostic Products Anti-SA Ortho-Clinical Diagnostics, Inc. DEN210040 05/05/2023
Breast Implant Removal Device (BIRD) Gaylord Solutions, LLC DEN220082 04/20/2023
NTX100 Tonic Motor Activation (NTX100 To Noctrix Health, Inc. DEN220059 04/17/2023
MISHA Knee System Moximed, Inc. DEN220033 04/10/2023
The N-SWEAT Patch Candesant Biomedical, Inc. DEN210055 04/07/2023
Masimo SafetyNet Masimo Corporation DEN200011 03/31/2023
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