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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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86 records meeting your search criteria returned- Product Code: QKP Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
ANDON MEDICAL CO.,LTD IHEALTH 01/20/2024
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT 11/30/2023
Unknown Manufacturer PILOT COVID 19 AT HOME TEST 05/09/2023
ANDON MEDICAL CO.,LTD IHEALTH 03/22/2023
ANDON MEDICAL CO.,LTD IHEALTH 03/22/2023
ABBOTT BINAXNOW 03/14/2023
HEALGEN SCIENTIFIC LLC CLINITEST RAPID COVID-19 ANTIGEN TEST 02/03/2023
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT 02/01/2023
ACON LABORATORIES, INC FLOW FLEX 09/19/2022
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF-TEST 08/22/2022
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