19 results
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32ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.
FDA Recall
Open, Classified
·Medtronic, PLC·Product code CCW·January 28, 2020
KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
FDA Recall
Terminated
·Medtronic Spine LLC, formerly Kyphon Inc·Product code HRX·February 4, 2009
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
FDA Recall
Open, Classified
·Medtronic CoreValve LLC·Product code DTI·January 14, 2020
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
FDA Recall
Open, Classified
·Medtronic CoreValve LLC·Product code DTI·January 14, 2020
Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code GEI·November 12, 2013
Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
FDA Recall
Terminated
·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016
Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc), Sunnyvale, CA Designed to reduce kyphosis that results from vertebral body collapse due to osteoporosis.
FDA Recall
Terminated
·Medtronic Spine LLC (formerly Kyphon Inc.)·Product code HRX·March 23, 2011
Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1B; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.
FDA Recall
Terminated
·Medtronic Spine LLC, formerly Kyphon Inc·Product code JDZ·November 10, 2009
Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1A; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.
FDA Recall
Terminated
·Medtronic Spine LLC, formerly Kyphon Inc·Product code NDN·November 10, 2009