8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
FDA 510(k)
FDA Class 1
·Ophthalmic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471159471·SAGITTAL BLADE - DE SOUTTER STANDARD 9 x 25 x 0...
SeaSpine® NewPort Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
GC XLC-100 CAPSULE
FDA 510(k)
FDA Class 2
·Dental
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
VIRTUOSO VR
FDA Adverse Event
MEDTRONIC EUROPE SARL·Product code LWS·October 8, 2010
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 28, 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