7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SCANFLEX SOLID COUPLANT MEMBRANE
FDA 510(k)
FDA Class 2
·Radiology
PENTAX Medical ENT Video Imaging System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BONEVUE
FDA 510(k)
FDA Class 2
·Radiology
ACCENT DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·February 28, 2013
VUEPOINT OCT SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code MNI·February 3, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 6, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024