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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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50 records meeting your search criteria returned- Product Code: LIT Product Problem: Material Split, Cut or Torn Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX PTA DILATATION CATHETER 01/08/2019
AV-TEMECULA-CT ARMADA 14 PTA CATHETER 12/28/2018
AV-TEMECULA-CT ARMADA 14 PTA CATHETER 12/26/2018
AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION 11/20/2018
AV-TEMECULA-CT ARMADA 18 PTA CATHETER 10/23/2018
AV-TEMECULA-CT ARMADA 18 PTA CATHETER 10/03/2018
BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER 09/24/2018
AV-TEMECULA-CT ARMADA 14 PTA CATHETER 07/26/2018
BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ 07/26/2018
BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ 07/19/2018
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