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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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38 records meeting your search criteria returned- Product Code: DYB Product Problem: No Apparent Adverse Event Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
OSCOR INC. ABIOMED INTRODUCER KIT FOR IMPELLA 10/15/2020
TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER 09/20/2019
CREGANNA MEDICAL ALSO D.B.A CREGANNA TAC LOTUS INTRODUCER SET 06/25/2019
W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL VER 3. 07/08/2018
W.L. GORE & ASSOCIATES GORE® DRYSEAL FLEX INTRODUCER SHEATH 04/03/2018
W.L. GORE & ASSOCIATES GORE® DRYSEAL SHEATH 02/28/2018
W.L. GORE & ASSOCIATES GORE® DRYSEAL FLEX INTRODUCER SHEATH 09/01/2017
W.L. GORE & ASSOCIATES GORE® DRYSEAL SHEATH 09/01/2017
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