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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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5 records meeting your search criteria returned- Product Code: DRE Product Problem: Leak/Splash Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ARGON MEDICAL DEVICES 6F PCI KIT/4 PERCUTANEOUS CATHETER INTRO 12/23/2021
COOK INC unknown brand name 06/26/2017
ARGON MEDICAL DEVICES, INC. PCI 5 KIT 7F 04/14/2016
BOSTON SCIENTIFIC CORP 6F SUPER SHEATH 08/28/2015
EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VA 05/26/2015
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