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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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39 records meeting your search criteria returned- Product Code: DXE Product Problem: Material Twisted/Bent Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 6 06/11/2020
PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6 10/29/2019
PENUMBRA, INC. INDIGO SYSTEM CAT RX ASPIRATION CATHETER 10/29/2019
ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE S 10/14/2019
PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6 10/02/2019
PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6 05/29/2019
PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 05/29/2019
PENUMBRA, INC. INDIGO SYSTEM CATD ASPIRATION CATHETER 05/29/2019
PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6 05/28/2019
PENUMBRA, INC. INDIGO SYSTEM 04/19/2019
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