16 results
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59ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·April 22, 2026
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·February 11, 2026
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·February 25, 2026
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; 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-10X3-E, Order Number G22667; 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-4X3, Order Number G22654; 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, Order Number G22655; 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-8X3, Order Number G22656; used to dilate strictures of the biliary tree
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·December 13, 2023
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·June 28, 2023
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·June 28, 2023
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
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
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·December 11, 2024
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
FDA Enforcement
Class II
·Ongoing·Wilson-Cook Medical Inc.·October 23, 2024