7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DERMASPANDERE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112
FDA 510(k)
FDA Class 2
·Cardiovascular
VPS Rhythm Device with TipTracker Technology
FDA 510(k)
FDA Class 2
·General Hospital
ENDEAVOR RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·June 10, 2014
MBT CEM KEEL TIB TRAY SZ2.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·December 6, 2012
MAXIMO II CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·October 7, 2010
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