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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 50 of 500 Results *
Decision Date To: 07/22/2019
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rf surgical generator Fulwell LLC K200931 11/24/2020
system, hemoglobin, automated: DiaSpect Tm EKF-diagnostic GmbH BK200520 11/24/2020
palacos r, palacos r pro, palacos r+g, palacos r+g pro, palacos mv+g Heraeus Medical GmbH K202475 11/23/2020
somnos anti-snoring mouth guard Koncept Innovators, LLC. K201484 11/23/2020
confirm rx insertable cardiac monitor Abbott (St. Jude Medical) K202888 11/23/2020
digital thermometer-(model bt-301, bt-302, bt-303, bt-305, bt-306, bt-308, bt-311, bt-318) Dongguan E-Test Technology Co., Ltd K193621 11/23/2020
invictus™ spinal fixation system Alphatec Spine, Inc. K203056 11/23/2020
medical surgical mask Shenzhen Everwin Precision Technology Co., Ltd. K201991 11/23/2020
mirus ligating clip, mirus ligating clip applier M/s. Meril Endo Surgery Private Limited K200166 11/23/2020
biogel eclipse / biogel eclipse indicator underglove, biogel surgeons / biogel indicator underglove, biogel pi micro indicator underglove, biogel pi ultratouch s surgical glove with a low dermatitis potential claim, biogel pi ultratouch s indicator underglove with a low dermatitis potential claim Molnlycke Health Care, US LLC K202090 11/22/2020

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