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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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10 records meeting your search criteria returned- Product Code: DYB Product Problem: Malposition of Device Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH 07/22/2022
W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH 05/15/2022
EDWARDS LIFE SCIENCES LLC. EDWARDS ESHEATH+ INTRODUCER SET 04/11/2022
W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH 02/26/2022
W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH 12/05/2021
ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT 10/12/2021
ARROW INTERNATIONAL, INC. ARROWG+ARD BLUE MAC CATHETER 03/10/2020
GREATBATCH MEDICAL MOBICATH BIDIRECTIONAL GUIDING SHEATH, S 07/17/2019
COOK INC PERFORMER MULLINS GUIDING SHEATH 10/09/2017
BARD ACCESS SYSTEMS 4.5 FR UNIVERSAL MICRO INTRODUCER KIT WI 08/16/2017
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