14 results
·
28ms
·
Sources: EU EUDAMED, US FDA
STARTRACK INFANT GRAPHICS MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·December 9, 2015
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·January 8, 2016
RTHawk, HeartVista Cardiac Package
FDA 510(k)
FDA Class 2
·Radiology
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
FDA 510(k)
FDA Class 2
·Radiology
XPS HANDPIECE - VISAO
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 2, 2021
DRILL 3334800 VISAO 80K HANDPIECE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ERL·July 2, 2013
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017
FLAIR ENDOVASCULAR STENT GRAFT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code MIH·February 1, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 2, 2011
HIRES 90K IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·July 3, 2014
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·June 9, 2016
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024