13 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Codman Metal Disposable ICP Kit Product Code: 80-1190 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code GWM·November 30, 2010
Codman Disposable Twist Drill Product code: 80-1200 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code GWM·November 30, 2010
Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code GWM·November 30, 2010
Ghajar Guide Ventriculostomy Kit Product Code: 80-1185 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code GWM·November 30, 2010
Codman Cranial Hand Drill Product Code: 82-6607 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code GWM·November 30, 2010
Codman Plastic Disposable ICP Kit, Complete, Adult Product Code 80-1197 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code GWM·November 30, 2010
Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010
Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010
Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010
Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, included in the kit.
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code GWM·February 9, 2012
CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code NJE·March 21, 2011
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013