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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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194 records meeting your search criteria returned- Product Code: DRE Product Problem: Fracture Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
MERIT MEDICAL SYSTEMS, INC. PRELUDE SHEATH INTRODUCER 03/26/2024
ANGIODYNAMICS, INC ANGIODYNAMICS 03/04/2024
CORDIS US CORP. AVANTI 01/04/2024
CORDIS US CORP. AVANTI TRANSRADIAL 12/26/2023
MERIT MEDICAL SYSTEMS INC. PRELUDE RADIAL SHEATH 12/12/2023
BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION 12/05/2023
ANGIODYNAMICS MINI STICK MAX 12/04/2023
MERIT MEDICAL SYSTEMS MEXICO MERIT S-MAK¿ COAXIAL MINI ACCESS KIT 11/01/2023
TOGO MEDIKIT CO., LTD. SUPER SHEATH 10/31/2023
MERIT MEDICAL SYSTEMS INC. PRELUDE RADIAL SHEATH 10/24/2023
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