10 results
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18ms
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Sources: EU EUDAMED, US FDA
AGAR P
FDA 510(k)
FDA Class 1
·Microbiology
Lymphotype HLA-DR/DQ 72
FDA UDI
Bio-Rad Medical Diagnostics GmbH·07611969952885·for 6 detections of human HLA-DR/DQ antigens in...
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788231020·Long Handle Curette #2 Ang
SOVEREIGN MINI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
SINGLE USE INJECTOR
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KNW·January 20, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 7, 2012
LEVEEN ELECTRODE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code GEI·September 1, 2010
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