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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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488 records meeting your search criteria returned- Product Code: FPA Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
ROCHE DIABETES CARE, INC. ACCU-CHEK FLEXLINK INFUSION SET 12/22/2020
SMITHS MEDICAL ASD, INC. CLEO 12/18/2020
SMITHS MEDICAL ASD, INC. CLEO ADMINISTRATION SET 12/15/2020
SMITHS MEDICAL ASD, INC. CLEO ADMINISTRATION SET 12/15/2020
C.R. BARD, INC. (BASD) -3006260740 PORT ACCESS NEEDLE 12/04/2020
SMITHS MEDICAL ASD, INC. CLEO INFUSION SET 11/28/2020
Unknown Manufacturer MIO ADVANCE 11/26/2020
ROCHE DIABETES CARE, INC. ACCU-CHEK INSIGHT FLEX 11/05/2020
SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM 10/29/2020
ROCHE DIABETES CARE, INC. ACCU-CHEK FLEXLINK INFUSION SET 10/13/2020
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