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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 500 Results *
Decision Date To: 07/22/2019
 
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emission computed tomography system Shanghai United Imaging Healthcare Co., Ltd K193241 01/26/2020
thd procto software system THD SpA K193512 01/26/2020
subdural strip/intraoperative split electrode, subdural grid/intraoperative grid electrode, dual-sided interhemispheric subdural electrode, multi-strip and slit grid subdural electrode, intraoperative mapping grid subdural electrode Ad-Tech Medical Instrument Corporation K191186 01/25/2020
aptus clavicle system Medartis AG K192984 01/24/2020
cellvizio 100 series system with confocal miniprobes Mauna Kea Technologies K191144 01/24/2020
stat profile prime plus analyzer system Nova Biomedical Corporation K193246 01/24/2020
blue nitrile examination gloves powder free JR Engineering & Medical Technologies (M) SDN.BHD. K192333 01/24/2020
persona personalized knee system Zimmer, Inc K193223 01/24/2020
disposable spo2 sensor Shenzhen SINO-K Medical Technology Co., Ltd. K192608 01/24/2020
iqon spectral ct Philips Medical Systems, Nederland B.V. K193454 01/24/2020

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