4 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
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
ASG-001; Ultrasound gel
FDA Enforcement
Class II
·Ongoing·Advance Medical Designs, Inc.·September 20, 2023
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
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024