8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3
FDA 510(k)
FDA Class 1
·Cardiovascular
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788229780·Tranquil-L ALIF Trial 18x36x28, 18 deg
STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
FDA 510(k)
FDA Class 2
·General Hospital
SANICLAVE 102, MODEL RS-SC-102
FDA 510(k)
FDA Class 2
·General Hospital
PLUM A+ DRIVER NEW 8
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 19, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 7, 2012
840
FDA Adverse Event
Malfunction
·COVIDIEN PURITAN BENNETT·Product code CBK·August 10, 2010
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012