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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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221 to 230 of 412 results
Decision Date To: 05/03/2024
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Download Files | More About De Novo
Device Name
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Requester
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De Novo
Number
sort by DeNovo number [0-9]
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510(k)
Number
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Decision
Date
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sort by decision date [9-0]
Ellipsys Vascular Access System Avenu Medical, Inc DEN170004 06/22/2018
everlinQ endoAVF System TVA Medical, Inc. DEN160006 06/22/2018
Bonebridge MED-EL Elektromedizinische Geraete GmbH DEN170009 07/20/2018
MolecuLight i:X MolecuLight Inc. DEN180008 07/31/2018
Natural Cycles Natural Cycles Nordic AB DEN170052 08/10/2018
Brainsway Deep Transcranial Magnetic Sti Brainways Ltd. DEN170078 08/17/2018
MATRx plus Zephyr Sleep Technologies DEN170090 08/23/2018
Irregular Rhythm Notification Feature Apple Inc DEN180042 09/11/2018
ECG App Apple Inc DEN180044 09/11/2018
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR CENTERS FOR DISEASE CONTROL AND PREVENTI DEN070001 09/21/2018
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