46 results
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38ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035''/480 cm. Disposable Single use only, Rx Only. Cook, Wilson-Cook Medicl GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code FEG·October 8, 2003
Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable Single Use Only, Rx Only***COOK Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code FPD·May 26, 2004
Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
FDA Recall
Terminated
·Cook Endoscopy·Product code KOG·October 5, 2006
Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
FDA Recall
Terminated
·Cook Endoscopy·Product code KNS·June 12, 2009
Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
FDA Recall
Terminated
·Cook Endoscopy·Product code KNQ·January 24, 2007
APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code FGE·July 25, 2003
EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Disposable-Single Use Only Sterile Shelf Life: 5 Years, Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston Salem, NC 27105.
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code FCG·April 23, 2002
Low Profile Gatrostomy - Contents include: Passport & Obturator * Disposable Single Use Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code KNT·June 9, 2005
Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook * Wilson Cook Medical GI Endoscopy * 4900 Bethania Station Road, Winston Salem, NC 27105
FDA Recall
Terminated
·Cook Endoscopy·Product code KOG·April 20, 2006
Acuject Variable Injection Needle
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code FBK·June 14, 2019
AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. The SASM device prefix denotes Soft AcuSnare Mini. The ASM device prefix denotes Acu Snare Mini. Due to the nitinol core wire, the difference between these two products is stiffness of the snare head wire.
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code FDI·April 21, 2004
FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy.
FDA Recall
Terminated
·Cook Endoscopy·Product code KNS·October 30, 2008
AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, packed 5 boxes, 10 units per box. This device is used with an electrosurgical unit for endoscopic polypectomy.
FDA Recall
Terminated
·Cook Endoscopy·Product code KNS·January 21, 2009
Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105.
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code GCA·August 28, 2002
Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code ESW·January 30, 2003
Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Used to train obstructed biliary ducts.
FDA Recall
Terminated
·Cook Endoscopy·Product code FGE·July 2, 2008
CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code FGE·June 9, 2005
Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Used to train obstructed biliary ducts.
FDA Recall
Terminated
·Cook Endoscopy·Product code FGE·July 2, 2008
Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
FDA Recall
Terminated
·Cook Endoscopy·Product code MND·September 3, 2010
Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable Single Use Only * Compatible Wire Guide: .035'' * Rx Only * Wilson-Cook Medical * GI Endoscope * 4900 Betharine Station * Winston-Salem, NC 27105
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code FGY·October 31, 2005