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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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293 records meeting your search criteria returned- Product Code: LIT Product Problem: Material Separation Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 03/12/2021
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 03/12/2021
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 03/10/2021
Unknown Manufacturer R2P CROSSTELLA RX 03/08/2021
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 02/25/2021
CLEARSTREAM TECHNOLOGIES LTD. LITEPAC RX PTA CATHETER 02/25/2021
BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA DILATATION CATHETER 02/17/2021
CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER 02/08/2021
KANEKA CORPORATION R2P METACROSS RX 01/22/2021
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 01/10/2021
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