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U.S. Department of Health and Human Services

510(k) Premarket Notification

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51 to 60 of 500 Results *
Decision Date To: 05/21/2019
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hemocue hb 301 system HemoCue AB K201217 08/04/2020
hyper dlr Shanghai United Imaging Healthcare Co., Ltd. K193210 08/04/2020
ecg monitor app Samsung Electronics Co., Ltd K201168 08/04/2020
etd family of electrotherapy devices TheraSigma, LLC K201958 08/04/2020
powder-free blue nitrile examination gloves (tested for use with chemotherapy and fentanyl) – regular cuff; powder-free blue nitrile examination gloves (tested for use with chemotherapy drugs and fentanyl) - extended cuff Medline Industries, Inc. K193666 08/04/2020
cureos tcp Linacol Muh Dan Kim Cev Tek Med Ith Ihr San Ve Tic K191670 08/04/2020
life spine plateau-a ti anterior lumbar spacer & plateau-x ti lateral lumbar spacer Life Spine Inc. K201500 08/04/2020
vector hammertoe correction system Nvision Biomedical Technologies, Inc K201850 08/04/2020
electrodes handpieces for mygen v-1000 rf system RF Medical Co., Ltd K193355 08/03/2020
attain select ii + surevalve delivery catheter system, attain command + surevalve left heart delivery system, attain comman + surevalve guide catheters for left heart delivery, c315 delivery catheter Medtronic Inc K192712 08/03/2020

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