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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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smartct r1.0 Philips Medical Systems, Nederland B.V. k201583 02/09/2021
lipps analyzer, lipps wire pressure guide wire Beijing Bywave Sensing Medical Technology Co., Ltd. k201720 02/18/2021
the aio solution 3.0 Orfit Industries NV k202068 08/14/2020
pullup btb adjustable fixation system for ligament reconstruction, pullup clip adjustable fixation system for ligament reconstruction, pullup tex clip adjustable fixation system for ligament reconstruction, bt loop adjustable fixation system for ligament reconstruction S.B.M. SAS (Science & Bio Materials) k202193 10/16/2020
powder free nitrile examination gloves (blue, violet blue, white, cobalt blue) Kanglongda Vietnam Protection Technology Company Limited k202356 03/02/2021
transtek wrist blood pressure monitor Guangdong Transtek Medical Electronics Co., Ltd. k202599 12/06/2020
medical surgical mask (non-sterile) Guangdong GoodFeeling Hygiene Material Tec Co., Ltd. k202761 04/11/2021
endopilot2 Schlumbohm GmbH & Co. KG k202906 04/13/2021
powder free nitrile surgical glove, sterile, tested for use with chemotherapy drugs WRP ASIA PACIFIC SDN BHD k203030 06/11/2021
multix impact c Siemens Medical Solutions USA, Inc. k203340 01/06/2021

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