7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PROPHYLAXIS PACK
FDA 510(k)
FDA Class 1
·Dental
Luna® Ti Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
E-CUBE 15 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·June 9, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 8, 2013
SALINE IMPLANTS
FDA Adverse Event
Injury
·Product code FWM·December 31, 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