7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CANNULA BAND
FDA 510(k)
FDA Class 1
·Anesthesiology
DERMASEL SUPPLEMENT
FDA 510(k)
FDA Class 1
·Microbiology
DETECTOR, MODEL LC-100 FLUORESCENCE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2014
SWAN NECK COIL-CATH CA2 RIGHT
FDA Adverse Event
Other
·COVIDIEN·Product code FJS·November 30, 2012
UNIVERSAL DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·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