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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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95 records meeting your search criteria returned- Product Code: MLV Product Problem: Biocompatibility Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM SEPTAL OCCLUDER 06/08/2023
W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM ASD OCCLUDER 02/06/2023
W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM SEPTAL OCCLUDER 11/11/2022
W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM SEPTAL OCCLUDER 07/15/2022
ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER 01/14/2022
ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER 12/17/2021
ABBOTT MEDICAL AMPLATZER CRIBRIFORM OCCLUDER 12/17/2021
ABBOTT MEDICAL AMPLATZER® CRIBRIFORM OCCLUDER 11/10/2021
ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER 11/07/2021
ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER 11/07/2021
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