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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
3 records meeting your search criteria returned- Product Code: PRL Product Problem: Burst Container or Vessel Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE EN 08/01/2022
CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW 11/14/2017
CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM 06/14/2017
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