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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 9 of 9 Results
PMA Number: P050006/S044
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Product Description
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Recall
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FDA Recall
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REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Leng... 2 10/22/2021 W L Gore & Associates, Inc.
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Leng... 2 10/22/2021 W L Gore & Associates, Inc.
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Leng... 2 10/22/2021 W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Leng... 2 10/22/2021 W L Gore & Associates, Inc.
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Leng... 2 10/22/2021 W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Leng... 2 10/22/2021 W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Len... 2 10/22/2021 W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Len... 2 10/22/2021 W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Leng... 2 10/22/2021 W L Gore & Associates, Inc.
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