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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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1 to 10 of 412 results
Decision Date To: 05/01/2024
 
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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Zuno Smart Sterilization Container Zuno Medical, Inc. DEN210004 06/17/2022
MATRx plus Zephyr Sleep Technologies DEN170090 08/23/2018
ZELTIQ AESTHETICS DERMAL COOLING DEVICE ZELTIQ AESTHETICS DEN090002 K080521 08/24/2010
D2 Dressing Z-MEDICA, LLC DEN160012 06/30/2017
AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC DEN130007 K123250 12/18/2013
LightStrike+ (MXSUV1-SL and MXSUV1-FT) Xenex Disinfection Services, Inc. DEN230007 09/01/2023
ALLOMAP MOLECULAR EXPRESSION TESTING XDX DEN080007 K073482 08/26/2008
OGmend Implant System Woven Orthopedic Technologies, LLC DEN180065 05/01/2020
Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc DEN170015 05/07/2018
BRAINPORT V100 DEVICE WICAB, INC DEN130039 06/18/2015
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