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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
 

 
 
10 records meeting your search criteria returned- Product Code: DYG Product Problem: Material Deformation Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
EDWARDS LIFESCIENCES LLC EDWARDS LIFESCIENCES SWAN-GANZ THERMODIL 05/25/2023
ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 4 FR 60CM 03/14/2023
ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 4 FR 50CM 10/19/2022
ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 7 FR 110CM 10/18/2022
ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 6 FR 90CM 10/14/2022
ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM 10/13/2022
ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM 09/28/2022
EDWARDS LIFESCIENCES LLC SWAN-GANZ VIP 06/11/2021
ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL 01/07/2021
EDWARDS LIFESCIENCES PR SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMO 11/02/2020
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