7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HAND-HELD SLIDE READER
FDA 510(k)
FDA Class 1
·Microbiology
MULTI-LUMEN CENTRAL VENOUS CATH. KIT
FDA 510(k)
FDA Class 2
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·October 14, 2010
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·December 14, 2012
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024