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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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8 records meeting your search criteria returned- Product Code: KRA Product Problem: Torn Material Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
BOSTON SCIENTIFIC - CORK DIREXION HI-FLO FATHOM-16 SYSTEM 06/14/2018
BOSTON SCIENTIFIC - MAPLE GROVE ANGIOJET® SOLENT¿ PROXI 12/19/2017
COOK INC CXI SUPPORT CATHETER 10/31/2017
COVIDIEN TRELLIS 8 80X25 03/12/2015
COVIDIEN TRELLIS 8 80X15 12/12/2014
COVIDIEN TRELLIS 8 120X25 12/09/2014
COVIDIEN TRELLIS 8 80X15 10/24/2014
PLYMOUTH TRELLIS 8 80X25 10/07/2014
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