Company
Medtronic Inc., Cardiac Rhythm and Heart Failure
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2017 | Medtronic Inc., Cardiac Rhythm and Heart Failure MyCareLink Smart Patient Monitors.
It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted he Terminated |
NVZ | None listed |
| Jul 14, 2017 | Medtronic Inc., Cardiac Rhythm and Heart Failure MyCareLink Patient Monitors.
It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted Terminated |
NVZ | None listed |
| Apr 12, 2017 | Medtronic Inc., Cardiac Rhythm and Heart Failure Amplia MRI Quad CRT-0 SureScan
Claria MRI Quad CRT-D SureScan
Compia MRI Quad CRT-D SureScan Terminated |
NIK | None listed |
| Dec 9, 2016 | Medtronic Inc., Cardiac Rhythm and Heart Failure Amplia MRI" CRT -D SureScan",
Amplia MRI" Quad CRT -D SureScan",
Claria MRI" CRT -D SureScan",
Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat epis Terminated |
NIK | None listed |
| Aug 25, 2016 | Medtronic Inc., Cardiac Rhythm and Heart Failure Medtronic, Evera Implantable Cardioverter Defibrillators:
Product Model
EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1.
EVERA S DDBC3D1, DDBC3D4
Product Usage:
The Medtron Terminated |
LWS | None listed |
| Aug 25, 2016 | Medtronic Inc., Cardiac Rhythm and Heart Failure Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators:
Product Model
VIVAXTCRT-D DTBA1D1, DTBA1D4
VIVASCRT-D DTBB1D1, DTBB1D4
Product Usage:
The Medtronic Viva Terminated |
LWS | None listed |
| Jul 5, 2016 | Medtronic Inc., Cardiac Rhythm and Heart Failure Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only.
The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care L Terminated |
NVZ | None listed |
| Jun 16, 2016 | Medtronic Inc., Cardiac Rhythm and Heart Failure Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO.
Product Catalog Numbers:
Five (5) Pack Single Pack
6416-100 6416-1005
6416-140 6416-1405
6416-200 6416-2005
Terminated |
LDF | K042190 |
| Mar 31, 2016 | Medtronic Inc., Cardiac Rhythm and Heart Failure 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 t Terminated |
NVZ | None listed |