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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 36 Results
ProductCode: KDI Applicant: FRESENIUS MEDICAL CARE Decision Date To: 05/24/2024
 
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5008x hemodialysis system Fresenius Medical Care K231534 02/02/2024
2008t bluestar hemodialysis machine Fresenius Medical Care Renal Therapies Group, LLC K231125 12/06/2023
fx coral 60, fx coral 80, fx coral 100, fx coral 120, fx coral 600, fx coral 800, fx coral 1000 Fresenius Medical Care Renal Therapies Group, LLC K220721 05/11/2023
multifiltratepro system Fresenius Medical Care Renal Therapies Group, LLC K220281 12/16/2022
2008t bluestar hemodailysis machine Fresenius Medical Care Renal Therapies Group, LLC K222952 10/27/2022
optiflux series of dialyzers f160nr, f180nr, f200nr Fresenius Medical Care Renal Therapies Group, LLC K203062 12/28/2020
optiflux f180nr dialyzer Fresenius Medical Care Renal Therapies Group, LLC K192707 09/21/2020
optiflux enexa f500 dialyzer Fresenius Medical Care Reanal Therapies Group LLC K192928 07/09/2020
2008t bluestar hemodialysis machine Fresenius Medical Care Renal Therapies Group, LLC K173972 05/10/2018
optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA K162488 04/06/2017
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