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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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121 to 130 of 413 results
Decision Date To: 05/17/2024
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Device Name
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De Novo
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510(k)
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Decision
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reSet PEAR THERAPEUTICS, INC. DEN160018 09/14/2017
WEST NILE VIRUS IGM CAPTURE ELISA PANBIO LIMITED DEN030004 K031703 07/08/2003
Paige Prostate Paige.AI DEN200080 09/21/2021
Oxehealth Vital Signs Oxehealth Limited DEN200019 03/26/2021
Dream Sock Owlet Baby Care, Inc. DEN220091 11/08/2023
remOVE System OVESCO ENDOSCOPY AG DEN160014 12/22/2017
Orthobond Mariner Pedicle Screw System Orthobond Coporation DEN220015 04/05/2024
InSpace Subacromial Tissue Spacer System Ortho-Space Ltd. DEN200039 07/12/2021
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
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