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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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6 records meeting your search criteria returned- Product Code: LIT Product Problem: Tear, Rip or Hole in Device Packaging Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
BARD PERIPHERAL VASCULAR, INC. DORADO 09/04/2023
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 07/13/2023
BARD PERIPHERAL VASCULAR, INC. ULTRASCORE 035 07/10/2023
CLEARSTREAM TECHNOLOGIES LTD. LITEPAC RX PTA CATHETER 03/17/2023
ABBOTT VASCULAR ARMADA 18 PTA CATHETER 11/16/2021
ABBOTT VASCULAR ARMADA 35 PTA CATHETER 07/09/2021
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