| 05/10/2013 |
Symbios |
GoPump Rapid Recovery System kits and GOBlock kits |
Potential for excessively high flow rates |
Symbios Medical Products |
 |
| 05/02/2013 |
Medtronic |
Deep Brain Stimulation (DBS) lead kits |
Deep Brain Stimulation (DBS) lead damage |
Medtronic, Inc. |
 |
| 04/15/2013 |
InsuLinx |
Blood Glucose Meter |
lnsuLinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. |
Abbott |
 |
| 04/10/2013 |
Stryker Corporation |
ShapeMatch Cutting Guides |
Due to the potential that ShapeMatch Cutting Guides may not have been manufactured in accordance with surgeon preoperative planning parameters or may have been manufactured outside of the planning ranges specified in the 510(k) clearance |
Stryker Corporation |
 |