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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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11 records meeting your search criteria returned- Product Code: KDI Patient Problem: Loss Of Pulse Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
GAMBRO DASCO SPA PHOENIX 02/02/2021
NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 11/24/2020
OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM 06/24/2020
OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM 06/24/2020
NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 04/03/2020
OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM 12/30/2019
NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 12/11/2019
BAXTER HEALTHCARE - OPELIKA REVACLEAR 300 04/15/2019
OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM 12/18/2018
OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 02/16/2018
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