8 results
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18ms
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Sources: EU EUDAMED, US FDA
SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE
FDA 510(k)
FDA Class 2
·Anesthesiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471184978·SAGITTAL BLADE - DE SOUTTER STANDARD 31 x 65 x ...
LAURYL TRYPTOSE BROTH
FDA 510(k)
FDA Class 1
·Microbiology
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·November 4, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 31, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 6, 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