7 results
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28ms
·
Sources: EU EUDAMED, US FDA
#19041-150X15MM MUELLER HINTON
FDA 510(k)
FDA Class 2
·Microbiology
TIXOS IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ALARIS PUMP MODULE ADMIN SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·April 30, 2014
PDS LL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code NEW·November 6, 2012
SMITH'S CADD CASSETTES
FDA Adverse Event
Injury
·SMITH'S MEDICAL·Product code FPA·August 25, 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