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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 412 results
Decision Date To: 05/02/2024
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Download Files | More About De Novo
Device Name
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De Novo
Number
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510(k)
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Decision
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XPERT EV, MODEL GXEV-100N-10; GENEXPERT CEPHEID DEN070004 K061062 03/16/2007
X100 with Full Field Bone Marrow Aspirat Scopio Labs Ltd. DEN230034 03/22/2024
WOUNDCHEK Bacterial Status Alere Scarborough, Inc. DEN180014 12/02/2019
WIDEXLINK IN CLEAR SERIES HEARING AIDS OFFICE RESEARCH IN CLINICAL AMPLIFICTION DEN100025 K101699 03/31/2011
WEST NILE VIRUS IGM CAPTURE ELISA PANBIO LIMITED DEN030004 K031703 07/08/2003
WallFlex Biliary RX Fully Covered Stent BOSTON SCIENTIFIC DEN150040 06/03/2016
WALLAC NEONATAL BIOTINIDASE TEST KIT, MO WALLAC, INC. DEN990008 K992284 02/15/2000
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN ABBOTT MOLECULAR, INC. DEN130010 K123951 07/29/2013
VYSIS AUTOVYSION SYSTEM VYSIS DEN040010 K041875 12/13/2004
vPatch Virility Medical DEN210012 11/23/2021
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