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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
 

 
 
3 records meeting your search criteria returned- Product Code: MAO Product Problem: Incorrect, Inadequate or Imprecise Result or Readings Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
BIOARRAY SOLUTIONS, LIMITED HEA 1.2 BEADCHIP TEST KIT 05/01/2023
NATERA NATERA NIPT 04/21/2022
Unknown Manufacturer VERIFI NIPT TEST 03/20/2015
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