7 results
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6ms
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Sources: EU EUDAMED, US FDA
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
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
FDA Enforcement
Class II
·Ongoing·Mizuho OSI·August 31, 2022
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
FDA Enforcement
Class II
·Ongoing·Mizuho OSI·March 31, 2021
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
UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006
FDA Enforcement
Class II
·Ongoing·UFSK - International OSYS Gmbh·July 26, 2023