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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
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ManufacturerBrand NameDate Report Received
ANDON MEDICAL CO., LTD IHEALTH COVID-19 ANTIGEN RAPID TEST 06/14/2022
ANDON MEDICAL CO.,LTD IHEALTH 06/14/2022
IHEALTH LABS / ANDON MEDICAL CO., LTD. IHEALTH COVID-19 ANTIGEN RAPID TEST 06/10/2022
IHEALTH LABS, INC. IHEALTH COVID19 RAPID ANTIGEN TEST KIT 06/01/2022
IHEALTH LABS, INC. IHEALTH COVID19 RAPID ANTIGEN TEST KIT 06/01/2022
CELLTRION DIATRUST / HUMASIS CO., LTD. COVID HOME TEST 05/23/2022
IHEALTH LABS, INC. COVID-19 ANTIGEN RAPID TEST 05/16/2022
BD RAPID DIAGNOSTICS (SUZHOU) CO. LTD. VERITOR AT-HOME COVID-19 DIGITAL TEST KI 05/13/2022
IHEALTH LABS, INC. IHEALTH 02/22/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 01/27/2022
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