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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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101 to 110 of 415 results
Decision Date To: 05/22/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
Date
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RemeOs™ Screw LAG Solid Bioretec Ltd. DEN220030 03/29/2023
RELIZORB ALCRESTA, INC. DEN150001 11/20/2015
RefleXion Medical Radiotherapy System (R RefleXion Medical Inc DEN220014 02/01/2023
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASS DIAGNOSTIC HYBRIDS, INC. DEN140004 K133448 05/13/2014
QUICKAIR CHOKE RELIEVER, MODEL 59-001A MAET INDUSTRIES, INC. DEN000004 K993284 02/29/2000
Quell-FM NeuroMetrix, Inc. DEN210046 05/18/2022
QuantX Quantitative Insights, Inc DEN170022 07/19/2017
Quantra Hemostasis Analyzer, QPlus Cartr HemoSonics, LLC DEN180017 03/12/2019
QUANTITATION OF ORGANOPHOSPHATE METABOL CENTERS FOR DISEASE CONTROL AND PREVENTI DEN130005 K122282 08/08/2013
Quantidex qPCR BCR-ABL IS Kit ASURAGEN, INC. DEN160003 07/22/2016
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