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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 417 results
Decision Date To: 06/21/2024
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Download Files | More About De Novo
Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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DreaMed Advisor Pro DreaMed Diabetes, Ltd. DEN170043 06/12/2018
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. DEN000008 K001447 02/16/2001
DuraGraft Marizyme, Inc. DEN230002 10/04/2023
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC CRANIAL TECHNOLOGIES, INC. DEN980001 K964992 05/29/1998
EarLens Contact Hearing Device EARLENS CORPORATION DEN150002 09/29/2015
Early Bird Bleed Monitoring System Saranas, Inc. DEN180021 03/01/2019
EaseVRx AppliedVR, Inc. DEN210014 11/16/2021
EasySep™ Human Bone Marrow CD138 Positiv STEMCELL Technologies Canada Inc. DEN220090 11/06/2023
ECG App Apple Inc DEN180044 09/11/2018
EchoTip Insight Portosystemic Pressure G Cook Ireland Ltd. DEN180062 11/20/2019
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