BEUDAMED
    2 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and catheters.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the introduction of various types of pacing or defibrillator leads and catheters.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024