7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
URDYN 5000 (UROFLOWMETER)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
INSPIRSTAR IS02 MICROCURRENT STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
EVO platform
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 5, 2012
HYPERGLIDE BALLOON SYSTEM
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code MJN·September 24, 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