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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 417 results
Decision Date To: 06/21/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
Date
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DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION DEN120016 K121215 05/09/2014
DentalMonitoring Dental Monitoring SAS DEN230035 05/17/2024
DENV DETECT IGM CAPTURE ELISA INBIOS INTL., INC. DEN100020 K100534 04/08/2011
dermaPACE System SANUWAVE, INC. DEN160037 12/28/2017
DermaSensor DermaSensor Inc. DEN230008 01/12/2024
Dexcom G6 Continuous Glucose Monitoring Dexcom, Inc. DEN170088 03/27/2018
Dexcom Share Direct Secondary Displays DEXCOM, INC. DEN140038 01/23/2015
DIAMOND PROBE/PERIO 2000 SYSTEM DIAMOND GENERAL DEVELOPMENT CORP. DEN980003 K980749 07/17/1998
Dignitana AB DigniCap System DIGNITANA AB DEN150010 12/08/2015
Dream Sock Owlet Baby Care, Inc. DEN220091 11/08/2023
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