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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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11 to 20 of 415 results
Decision Date To: 05/24/2024
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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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Acumen Assisted Fluid Management (AFM) S Edwards Lifesciences DEN190029 11/13/2020
Acumen Hypotension Prediction Index (HPI Edwards Lifesciences LLC DEN160044 03/16/2018
Adaptive Biotechnologies clonoSEQ Assay Adaptive Biotechnologies Corporation DEN170080 09/28/2018
ADVIA Centaur Enhanced Liver Fibrosis (E Siemens Healthcare Diagnostics Inc. DEN190056 08/20/2021
AeroForm Tissue Expander System AIRXPANDERS, INC DEN150055 12/21/2016
AFFYMETRIX GENECHIP MICROARRAY INSTRUMEN Affymetrix, Inc. DEN040012 K042279 12/23/2004
AHIP INTERNAL TRIGGER POINT WAND MODEL: NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEN100023 K100934 11/20/2012
AIRPURGE ANESTHESIA SAFETY PRODUCTS, LLC DEN080009 K080644 03/04/2014
Alethia CMV DNA Amplification Assay, Ale Meridian Bioscience, Inc. DEN180040 11/30/2018
ALLOMAP MOLECULAR EXPRESSION TESTING XDX DEN080007 K073482 08/26/2008
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