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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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9 records meeting your search criteria returned- Product Code: DRE Product Problem: Device Dislodged or Dislocated Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
ACUTUS MEDICAL, INC. ACQCROSS QX INTEGRATED NEEDLE/DILATOR 03/19/2024
COOK MEDICAL / COOK, INC. STEADYSHEATH 13 FR EVOLUTION 01/31/2022
ANGIODYNAMICS, INC ANGIODYNAMIC MICRO-INTRODUCER 02/02/2021
ANGIODYNAMICS, INC. / NAVILYST MEDICAL, COAXIAL MICROINTRODUCER KIT MINI STICK M 03/16/2020
MERIT MEDICAL SYSTEMS, INC. MERRIT PRECLUDE DEAL SHEATH 03/11/2020
ANGIODYNAMICS MINISTICK MICROPUNCTURE KIT MAX 5F X 10 09/20/2019
SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR 01/07/2016
GALT MEDICAL CORP unknown brand name 10/09/2014
SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING MECHANI 06/06/2014
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