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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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91 to 100 of 416 results
Decision Date To: 06/02/2024
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Device Name
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510(k)
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B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test Sy BRAHMS GmbH, Part of Thermo Fisher Scien DEN220027 05/18/2023
BrainTemp Neonate System (BTNeo System) Brain Temp Inc. DEN200042 03/29/2022
The Cooral System BrainCool AB DEN210027 10/14/2022
BrainScope Ahead 100 BRAINSCOPE COMPANY, INC DEN140025 11/17/2014
Brainsway Deep Transcranial Magnetic Sti Brainways Ltd. DEN170078 08/17/2018
SEM Scanner (Model 200) Bruin Biometrics, LLC DEN170021 12/20/2018
MALDI Biotyper CA System Bruker Daltonik GmbH DEN170081 04/20/2018
CABOCHON SYSTEM CABOCHON AESTHETICS, INC. DEN110004 K101231 07/12/2013
Cala ONE Cala Health, Inc. DEN170028 04/26/2018
Canary Tibial Extension with Canary Heal Canary Medical, Inc. DEN200064 08/27/2021
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