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U.S. Department of Health and Human Services

510(K) Premarket Notification
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rune labs tremor transducer system Rune Labs, Inc. k213519 06/10/2022
aluminum back folding wheelchair syiv 100-lqxal2482-407 Mobility Source Medical Technology Co., Ltd. k213790 03/14/2022
biosci™ inactivated transport medium, biosci™ itm Shenzhen Dakewe Bio-engineering Co., Ltd. k220059 01/19/2023
esthetic abutments nobel biocare n1 Nobel Biocare Services AG k220339 09/16/2022
disposable vinyl examination glove Chifeng Huawei Medical Science&Technology Co.,Ltd. k220469 06/16/2022
vivid e80, vivid e90, vivid e95 GE Medical Systems Ultrasound and k220882 07/22/2022
peri-guard repair patch, supple peri-guard repair patch Synovis Life Technologies, Inc. k221029 10/19/2022
promisemed blood lancet, verifine safety lancet, verifine mini-safety lancet Promisemed Hangzhou Meditech Co., Ltd. k221368 06/09/2022
surgical gown (sterile); surgical gown (non-sterile) Allmed Medical (Hubei) Protective Products Co., Ltd k221637 09/29/2022
cellfx® system Pulse Biosciences, Inc. k221671 08/01/2022

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