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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: QKP Patient Problem: Malaise Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW 12/15/2023
ANDON MEDICAL CO.,LTD IHEALTH 10/07/2023
ANDON MEDICAL CO.,LTD IHEALTH 10/07/2023
IHEALTH MANUFACTURING, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST FDA 08/28/2023
IHEALTH MANUFACTURING INC. IHEALTH COVID-19 ANTIGEN RAPID TEST FDA 08/28/2023
Unknown Manufacturer COVID 19 ANTIGEN RAPID TEST 07/26/2023
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 02/08/2023
ACON LABORATORIES, INC. COVID-19 ANTIGEN HOME TEST 11/17/2022
ACON LABORATORIES, INC. COVID-19 ANTIGEN HOME TEST 11/17/2022
Unknown Manufacturer COVID-19 ANTIGEN TESTS 10/29/2021
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