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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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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: OQS Report Date From: 1/1/2023 Report Date To: 12/31/2023

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ManufacturerBrand NameDate Report Received
Unknown Manufacturer LABORATORY DEVELOPED TEST 12/14/2023
NATERA NATERA PANORAMA NIPT TEST (NON-INVASIVE 06/13/2023
DERMTECH DERMTECH MELANOMA DETECTION 06/06/2023
OPANS, LLC. AMASSE BIO-FLUID DETECTION DEVICE 04/25/2023
UNKNOWN MYRIAD NIPT TEST 01/13/2023
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