3 results
·
21ms
·
Sources: EU EUDAMED, US FDA
PENUMBRA MAX PUMP - INDIGO SYSTEM
FDA Adverse Event
Malfunction
·PENUMBRA INC., USA·Product code NRY·August 23, 2018
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 14, 2019
Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.
FDA Recall
Terminated
·Concentric Medical Inc·Product code GBS·February 27, 2009