7 results
·
23ms
·
Sources: EU EUDAMED, US FDA
KOORDINAT ANGIO
FDA 510(k)
FDA Class 2
·Radiology
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Heat Pain Pro
FDA 510(k)
FDA Class 2
·Neurology
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 30, 2014
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM - VASCULAR/THIN
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·January 24, 2008
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021