7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MP-500 ELECTRONIC NEBULIZER
FDA 510(k)
FDA Class 1
·Anesthesiology
EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
S4 Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code LFL·April 1, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 5, 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