9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ACCESSORY MEDIA FOR FLOW TITERTEK MIC
FDA 510(k)
FDA Class 2
·Microbiology
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788221190·Steerable IBD Trial 8x11x37, 6 deg
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M7526822119·
DX-D FULL LEG FULL SPINE
FDA 510(k)
FDA Class 2
·Radiology
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·May 20, 2014
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 7, 2012
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·September 1, 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