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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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201 to 210 of 412 results
Decision Date To: 05/04/2024
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KRONUS Aquaporin-4 Autoantibody (AQP4Ab) KRONUS, INC. DEN150030 04/25/2016
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L WAKO CHEMICALS, USA, INC. DEN050002 K041847 05/19/2005
Leica FL400 Leica Microsystems (Schweiz) AG DEN180024 03/28/2019
Lenire Tinnitus Treatment Device Neuromod Devices Limited DEN210033 03/06/2023
LightStrike+ (MXSUV1-SL and MXSUV1-FT) Xenex Disinfection Services, Inc. DEN230007 09/01/2023
LIPFLOW THERMAL PULSATION SYSTEM (FORMER TEARSCIENCE, INC. DEN100017 K093937 06/28/2011
LOADPRO™ Intraoperative Rod Strain Senso Intellirod Spine, Inc. DEN180012 03/28/2019
Lumenis Stellar M22 Lumenis Ltd. DEN200028 02/23/2021
Luminopia One Luminopia, Inc. DEN210005 10/20/2021
Lumipulse G ß-Amyloid Ratio (1-42/1-40) Fujirebio Diagnostics, Inc. DEN200072 05/04/2022
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