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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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body contouring machine (models: cs2, cs3, cs5, cs7, cs8, cs11, cs13) Hebei JT Medical Co., Ltd. k232181 04/24/2024
medical nitrile examination gloves Jiangsu Complete Sincerity Medical New Materials Co., Ltd. k232576 11/21/2023
smart muscle training wearables (model:sm9027,sm9027,sm9566,sm9065n) Chongqing Rob Linka Science And Technology Co., Ltd. k233070 03/13/2024
silent nite® sleep appliance with the glidewell hinge™ (snglhg) Prismatik Dentalcraft, Inc k233434 11/14/2023
disposable safety lancet (impress); disposable safety lancet (impress pro); disposable safety lancet (lite4); disposable blood lancet (elite); disposable blood lancet (elite pro) SteriLance Medical (Suzhou) Inc. k233796 01/16/2024
bd vacutainer® push button blood collection set, bd vacutainer® push button blood collection set with pre-attached holder Becton, Dickinson and Company k220212 03/24/2023
vinyl co-polymer powder-free examination gloves, black Grand Work Plastic Products Co., Ltd k220240 03/31/2022
vortex surgical laser probes, vortex surgical illuminated laser probes, vortex surgical endoilluminators, vortex surgical chandeliers Vortex Surgical Inc k220263 11/03/2022
accuryn monitoring system, accuryn smartfoley iap uo temp tray system 12 f, accuryn smartfoley iap uo temp tray system 14 f Potrero Medical, Inc. k221020 01/13/2023
silentcloud Aureliym GmBH k221125 01/04/2023

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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