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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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15f isleeve introducer set, 14f isleeve introducer set Boston Scientific Corporation K191871 08/07/2019
3m comply hydrogen peroxide chemical indicator 3M Company K192937 11/16/2019
3shape splint design 3Shape A/S K191911 11/27/2019
access ct Philips Healthcare (Suzhou) Co., Ltd. K191136 07/29/2019
accucath ace intravascular catheter C.R. Bard, Inc K191232 09/18/2019
accufill bone substitute material Zimmer Knee Creations K190814 06/10/2019
accurate multi panel drug urine test cup Healstone Biotech Inc K191841 08/07/2019
acqmap high resolution imaging and mapping system Acutus Medical, Inc. K190131 04/02/2019
acuity sdr standard, acuity sdr plus, acuity fdr standard Radmedix LLC K193360 01/02/2020
additive cap International Medical Industries, Inc. K190305 04/30/2019

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