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MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

FDA Enforcement
Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 13, 2019

Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)

FDA Enforcement
Class II ·Terminated·Medtronic Neurosurgery·February 21, 2018

Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer

FDA Enforcement
Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 27, 2019

Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pumps) The catheter is designed for use in the intrathecal space. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.

FDA Recall
Terminated ·Medtronic Neurological·Product code LKK·July 21, 2006

Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA.

FDA Recall
Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code LWP·October 11, 2010

Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing by the physician. The data is transmitted either through an analog telephone line, a cellular connection or an internet connection.

FDA Enforcement
Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure·May 11, 2016

Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·March 23, 2009

Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA.

FDA Recall
Terminated ·Medtronic Gastroenterology Urology·Product code KLA·April 6, 2006

Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.

FDA Enforcement
Class II ·Terminated·Medtronic Neuromodulation·May 14, 2014

Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies. Medtronic World Headquarters, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.

FDA Recall
Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code LWS·October 15, 2007

Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

Medtronic SynchroMed EL Programmable Pump, Model 8627-10. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

Medtronic SynchroMed EL Programmable Pumps, Model 8626L-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

Medtronic SynchroMed EL Programmable Pumps, Model 8627-18, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

Medtronic SynchroMed EL Programmable Pumps, Models 8626-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

Medtronic SynchroMed EL Programmable Pump, Model 8627-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

Medtronic SynchroMed EL Programmable Pump, Model 8626-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

Medtronic SynchroMed EL Programmable Pumps, Model 8627-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007