7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
APPLIDYN
FDA 510(k)
FDA Class 2
·Physical Medicine
DIFFERENTIATION DISKS HIPPURATE
FDA 510(k)
FDA Class 1
·Microbiology
80 MG/DL GLUCOSE CONTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GORE® DRYSEAL SHEATH
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DYB·June 10, 2014
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code DTK·December 10, 2012
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 4, 2010
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024