8 results
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21ms
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Sources: EU EUDAMED, US FDA
IVEX MODEL NO. BP 3000 BREASTPUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Corin Optimized Positioning System (OPS) Femoral
FDA 510(k)
FDA Class 2
·Orthopedic
PINPOINTE FOOTLASER MODEL 6W, 30W, 100W
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·January 2, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 8, 2010
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·February 15, 2014
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012
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