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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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35 records meeting your search criteria returned- Product Code: QKP Product Problem: Manufacturing, Packaging or Shipping Problem Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
IHEALTH LABS, INC. I HEALTH COVID-19 07/05/2022
IHEALTH LABS, INC. I HEALTH COVID-19 07/05/2022
IHEALTH LABS, INC. I HEALTH COVID-19 07/05/2022
IHEALTH LABS, INC. I HEALTH COVID-19 07/05/2022
IHEALTH LABS, INC. I HEALTH COVID-19 07/05/2022
IHEALTH LABS, INC. I HEALTH COVID-19 07/05/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 05/31/2022
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 05/26/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGENT RAPID TEST 03/31/2022
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINASNOW COVID-19 ANTIGEN SELF-TEST 03/22/2022
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