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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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15 records meeting your search criteria returned- Product Code: QKP Product Problem: Defective Component Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 08/22/2022
MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 08/22/2022
MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 08/22/2022
MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 08/22/2022
MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 08/22/2022
MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 08/22/2022
MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 08/22/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 07/28/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 07/28/2022
ROCHE (DIST.) SD BIOSENSOR COVID-19 AT-HOME TEST 07/26/2022
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