7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
VAN-TEC DEFLECTING GRASPING FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Fingertip Pulse Oximeter MD300CG11/MD300CG51
FDA 510(k)
FDA Class 2
·Cardiovascular
PEDIATRIC URINARY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
PONTO WIDE IMPLANT WITH ABUTMENT
FDA Adverse Event
Other
·OTICON MEDICAL AB·Product code MAH·November 23, 2012
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·September 22, 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