431 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·December 13, 2023
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·December 13, 2023
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·April 24, 2019
Acuject Variable Injection Needle
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·August 7, 2019
Hemospray Endoscopic Hemostat
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·September 25, 2019
HEMO-7 Hemospray Endoscopic Hemostat
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·April 29, 2020
HEMO-10 Hemospray Endoscopic Hemostat
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·April 29, 2020
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·August 9, 2023
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·August 9, 2023
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 1, 2026
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024