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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 500 Results *
Decision Date To: 05/21/2019
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pentax medical epk-i7010 and pentax epk-i5010 video processors with gi family PENTAX of America, Inc. K191282 11/08/2019
aptus wrist arthrodesis plates Medartis AG K192297 11/08/2019
contour® next blood glucose monitoring system, contour® next usb blood glucose monitoring system, contour® next one blood glucose monitoring system, contour® next ez blood glucose monitoring system, contour® next link wireless blood glucose monitoring system Ascensia Diabetes Care K191286 11/08/2019
crp vario Sentinel CH, Spa K192118 11/08/2019
hivox spopad ems sp-911, sp-921 Hivox Biotek Inc. K192264 11/08/2019
nitrile powder free examination glove with low dermatitis potential claim (white) Hartalega NGC Sdn. Bhd. K192232 11/08/2019
quantx breast mri biopsy guidance plugin Qlarity Imaging K191959 11/08/2019
visalys cemcore, visalys cem core try in paste Kettenbach GmbH & Co. KG K191527 11/08/2019
vk100 percutaneous vertebral augmentation system BONWRx Ltd K192403 11/08/2019
ba pit & fissure sealant Apex Dental Materials, Inc. K190998 11/08/2019

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