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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
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125 records meeting your search criteria returned- Product Code: QKP Product Problem: Product Quality Problem Report Date From: 01/1/2017
New Searchexport reports to excelExport to Excel | HelpHelp
ManufacturerBrand NameDate Report Received
IHEALTH IHEALTH COVID-19 ANTIGEN RAPID TEST 08/17/2022
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 08/16/2022
ELLUME USA LLC. ELLUME COVID-19 HOME TEST 08/10/2022
ABBOTT BINAXNOW ANTIGEN SELF TEST 08/08/2022
ABBOTT BINAXNOW ANTIGEN SELF TEST 08/08/2022
ELLUME USA LLC. ELLUME COVID-19 HOME TEST 08/05/2022
ELLUME USA LLC. ELLUME COVID-19 HOME TEST 08/01/2022
Unknown Manufacturer COVID RAPID TEST 07/28/2022
QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID 19 TEST 07/22/2022
QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID 19 TEST 07/22/2022
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