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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
Number
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Decision
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fresenius a2008 hemodialysis machine expansion mod Seratronics, Inc. k844750 02/15/1985
biodentine Septodont k140132 06/27/2014
sentec digital monitoring system Sentec AG k071672 09/12/2007
transpara 1.7.0 Screenpoint Medical B.V. k210404 06/02/2021
scimed 6 french angiographic catheter modification Scimed Life Systems, Inc. k934541 05/12/1994
aristotle 18 guidewire, 200cm, soft profile ; aristotle 18 guidewire, 200cm, standard profile ; aristotle 18 guidewire, 200cm, support profile Scientia Vascular, LLC k183608 03/22/2019
k-shield zen (model numbers: pbmh/ pbma/ pbm) Sb-Kawasumi Laboratories, Inc. k230408 06/01/2023
oxygen mask, air-entrainment Salter Labs k772127 01/03/1978
rxsight insertion device Rxsight, Inc. k192926 01/17/2020
rossmax non-invasive blood pressure monitors, models s380, k350 Rossmax International , Ltd. k052727 12/16/2005

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