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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
 

 
 
7 records meeting your search criteria returned- Product Code: NQM Product Problem: False Negative Result Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
QIAGEN AMNISURE 11/18/2022
QIAGEN SCIENCES, LLC AMNISURE ROM TEST 02/19/2020
QIAGEN SCIENCES, LLC AMNISURE ROM TEST 05/14/2019
QIAGEN SCIENCES, LLC AMNISURE ROM TEST 04/29/2019
QIAGEN SCIENCES, LLC AMNISURE ROM TEST 05/14/2018
CLINICAL INNOVATIONS, LLC ROM PLUS RUPTURE OF MEMBRANES TEST 03/07/2018
CLINICAL INNOVATIONS, LLC ROM PLUS FETAL MEMBRABE RUPTURE TEST 09/18/2017
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