7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
TEEN CLEAN, RETAINER CLEANER
FDA 510(k)
FDA Class 1
·Dental
SCATTERED TRANSMISSION ACCESSORY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SINMED POSITIONING DEVICES
FDA 510(k)
FDA Class 2
·Radiology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWP·June 10, 2014
LIBERTE' CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code MAF·October 7, 2010
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 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