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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
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14 records meeting your search criteria returned- Product Code: DYB Product Problem: Manufacturing, Packaging or Shipping Problem Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDIN 03/08/2022
TERUMO MEDICAL CORPORATION PINNACLE 08/31/2021
BIOSENSE WEBSTER INC CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING 01/08/2021
TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER NITINOL 11/12/2020
W. L. GORE ASSOCIATES, INC. GORE DRYSEAL FLEX INTRODUCER SHEATH 09/11/2020
ST. JUDE MEDICAL ENGAGE 09/01/2020
W. L. GORE ASSOCIATES, INC. GORE DRYSEAL FLEX INTRODUCER SHEATH 05/05/2020
OSCOR INC SAFESHEATH® II 11/20/2019
GREATBATCH MEDICAL VIAPEEL PTFE PEELABLE INTRODUCERS 04/12/2019
OSCOR INC. ADELANTE RADIAL 6F 09/17/2018
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