8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
Ez3D-i / E3
FDA 510(k)
FDA Class 2
·Radiology
ENDOSCOPIC SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRAFLEX
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
4.5MM ANGLED TOMCAT CUTTER, FORMULA (5BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code HRX·October 1, 2010
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FNL·November 2, 2012
SAW ROUND 38.9*Ø5 Ø0.6 F/PIEZOELECTRIC S
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code DZI·December 4, 2015
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