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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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118 records meeting your search criteria returned- Product Code: LIT Product Problem: Material Separation Report Date From: 01/1/2014
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ManufacturerBrand NameDate Report Received
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 08/14/2019
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 08/05/2019
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 08/01/2019
Unknown Manufacturer OHICHO3 07/19/2019
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 07/11/2019
AV-TEMECULA-CT ARMADA 35 PTA CATHETER 07/10/2019
AV-TEMECULA-CT ARMADA 35 PTA CATHETER 07/08/2019
AV-TEMECULA-CT ARMADA 14 PTA CATHETER 06/28/2019
Unknown Manufacturer OHICHO3 06/27/2019
KANEKA SENRI 06/26/2019
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