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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 416 results
Decision Date To: 06/13/2024
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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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REWALK ARGO MEDICAL TECHNOLOGIES, INC. DEN130034 K131798 06/26/2014
PROSTATE IMMOBILIZER RECTAL BALLOON RADIADYNE DEN130036 K132194 01/28/2014
BRAINPORT V100 DEVICE WICAB, INC DEN130039 06/18/2015
IOGYN SYSTEM IOGYN, INC. DEN130040 K132695 03/28/2014
MISEQDX UNIVERSAL KIT 1.0 ILLUMINA, INC. DEN130042 K133136 11/19/2013
INFLOW INTRAURETHRAL VALVE-PUMP VESIFLO, INC. DEN130044 10/14/2014
HEARTFLOW FFRCT HEARTFLOW DEN130045 11/26/2014
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPH SOMNA THERAPEUTICS, LLC DEN130046 03/06/2015
PROLONG ERGON MEDICAL LTD. DEN130047 03/20/2015
SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS DEN130049 K133621 03/21/2014
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