7 results
·
33ms
·
Sources: EU EUDAMED, US FDA
ULTIPOR SQ40S BLOOD TRANSFUSION FILTER
FDA 510(k)
FDA Class 2
·General Hospital
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
FDA 510(k)
FDA Class 2
·Orthopedic
MYOGUIDE SYSTEM MODEL 8008
FDA 510(k)
FDA Class 2
·Anesthesiology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 15, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
MCK ONLY INSERT
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code HSX·August 6, 2010
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