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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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279 records meeting your search criteria returned- Product Code: OUT Product Problem: Break Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY 04/19/2019
MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX 04/04/2019
MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX 04/01/2019
MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY 03/12/2019
MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX 03/11/2019
COVIDIEN (IRVINE) PIPELINE FLEX 12/11/2018
COVIDIEN (IRVINE) PIPELINE FLEX W/SHIELD TECHNOLOGY 12/07/2018
COVIDIEN (IRVINE) PIPELINE FLEX 12/07/2018
COVIDIEN (IRVINE) PIPELINE FLEX 12/07/2018
MEDTRONIC NEUROVASCULAR PIPELINE 12/04/2018
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