8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
QUALI-MED'S OPERATING ROOM DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FETCH ASPIRATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
EBit Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
QUADROX-I ADULT WITHOUT FILTER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 4, 2014
WATERS QUATTRO PREMIER
FDA Adverse Event
Malfunction
·WATERS CORP.·Product code DOP·December 5, 2012
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012