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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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51 to 60 of 416 results
Decision Date To: 06/01/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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BraidE Embolization Assist Device Rapid Medical Ltd. DEN230064 02/21/2024
BRAINPORT V100 DEVICE WICAB, INC DEN130039 06/18/2015
BrainScope Ahead 100 BRAINSCOPE COMPANY, INC DEN140025 11/17/2014
BrainSee Darmiyan, Inc. DEN220066 01/11/2024
Brainsway Deep Transcranial Magnetic Sti Brainways Ltd. DEN170078 08/17/2018
BrainTemp Neonate System (BTNeo System) Brain Temp Inc. DEN200042 03/29/2022
Breast Implant Removal Device (BIRD) Gaylord Solutions, LLC DEN220082 04/20/2023
BREASTVIEW VISUAL MAPPING SYSTEM ASSURANCE MEDICAL DEN020001 K010514 01/31/2003
BT-001 Better Therapeutics DEN220058 07/07/2023
CABOCHON SYSTEM CABOCHON AESTHETICS, INC. DEN110004 K101231 07/12/2013
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