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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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2 records meeting your search criteria returned- Product Code: DRE Product Problem: Occlusion Within Device Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
ARGON MEDICAL DEVICES, INC. PCI 5 KIT 7F 04/14/2016
SPECTRANETICS CORPORTATION SPECTRANETICS VISISHEATH DILATOR SHEATH 12/02/2014
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