8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GUAMSTAINER
FDA 510(k)
FDA Class 1
·Pathology
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
EBI XFIX ACCESS PELVIC FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2014
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 23, 2007
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWP·October 31, 2012
CORAIL2 STD SIZE 9
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code KWA·August 11, 2017
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