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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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5 records meeting your search criteria returned- Product Code: QKP Patient Problem: Swelling/ Edema Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 07/12/2022
HEALGEN SCIENTIFIC CLINITEST RAPID COVID-19 ANTIGEN TEST 04/11/2022
ANDON MEDICAL CO.,LTD IHEALTH 03/10/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 02/04/2022
Unknown Manufacturer COVID TEST NASAL 01/13/2022
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