7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NEUROSCOPE SEEG
FDA 510(k)
FDA Class 2
·Neurology
BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ortho System
FDA 510(k)
FDA Unclassified
·Unknown
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 13, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 8, 2010
GENTLEPOWER LUX CONTRA ANGLE 25LPR
FDA Adverse Event
Injury
·KAVO DENTAL GMBH·Product code EFB·November 29, 2012
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