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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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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.
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ManufacturerBrand NameDate Report Received
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 03/28/2024
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 03/28/2024
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT 03/23/2024
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 03/19/2024
ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST 03/12/2024
ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST 03/12/2024
ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST 03/12/2024
QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST 03/06/2024
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 03/05/2024
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 03/05/2024
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