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U.S. Department of Health and Human Services

510(K) Premarket Notification

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asnis® iii cannulated screw system and asnis® pro cannulated screw system Stryker GmbH k213199 01/11/2022
medical nitrile examination gloves Hunan Zhenheyikang Medical Instrument Co., Ltd k220066 04/03/2022
pink powder free nitrile examination glove with bubblegum scented, chemotherapy drugs and fentanyl test claim Riverstone Resources Sdn Bhd k220401 04/09/2022
venus blissmax Venus Concept USA Inc. k220592 04/27/2022
biofire joint infection (ji) panel BioFire Diagnostics, LLC den200066 04/29/2022
wx non-automated blood pressure meter,model wx02, wx non-automated blood pressure meter with stethoscope, model wx0201, wx0202, wx0203 Wenzhou Xikang Medical Instruments Co., Ltd k212416 05/18/2022
ipl hair removal device, model(s): ui04a, ui04b, ui04c Shenzhen Ulike Smart Electronics Co.,Ltd k221002 06/01/2022
fora advanced gd40 glucose, ß-ketone and cholesterol monitoring system TaiDoc Technology Corporation k201037 06/16/2022
wireless digital flat panel detector iRay Technology Taicang Ltd. k221345 06/16/2022
single-use video bronchoscopes, digital controller Micro-Tech (Nanjing) Co., Lts k213782 07/08/2022

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