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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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111 records meeting your search criteria returned- Product Code: DRE Product Problem: Break Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ARGON MEDICAL DEVICES 7F CATH LAB INTRODUCER KIT 11/15/2023
ARGON MEDICAL DEVICES CLOSUREFAST MICRO INTRODUCER SHEATH SET 10/02/2023
ARGON MEDICAL DEVICES CLOSUREFAST MICRO PUNCTURE KIT 4FR/CH (1 10/02/2023
ARGON MEDICAL DEVICES CLOSUREFAST MICRO INTRODUCER SHEATH SET 08/29/2023
Unknown Manufacturer TIGHTRAIL SHEATH 07/14/2023
CORDIS US CORP. SI AVANTI+ 9F STD W/GW NO OBT 06/29/2023
CORDIS US CORP. SI AVANTI+ 8F STD W/GW NO OBT 06/29/2023
ARGON MEDICAL DEVICES CLOSUREFAST MICRO INTRODUCER SHEATH SET 05/30/2023
MERIT MEDICAL SYSTEMS, INC. MERIT MEDICAL MINI ACCESS KIT 05/24/2023
ARGON MEDICAL DEVICES CLOSUREFAST MICRO INTRODUCER SHEATH SET 05/23/2023
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