15 results
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35ms
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Sources: EU EUDAMED, US FDA
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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 Enforcement
Class II
·Ongoing·Medtronic, PLC·March 11, 2020
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
FDA Enforcement
Class II
·Ongoing·Medtronic CoreValve LLC·March 18, 2020
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
FDA Enforcement
Class II
·Ongoing·Medtronic CoreValve LLC·March 18, 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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 12, 2014
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017
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 Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 8, 2017