8 results
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25ms
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Sources: EU EUDAMED, US FDA
ORAL AIRWAY
FDA 510(k)
FDA Class 1
·Anesthesiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471145818·SAGITTAL BLADE - DE SOUTTER STANDARD 31 x 85 x ...
VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN
FDA 510(k)
FDA Class 2
·General Hospital
ELVI 818 DIGICLOT MULTISCAN
FDA 510(k)
FDA Class 2
·Hematology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2014
CAHP-150 CELLULOSE DIACETATE DIALYZER
FDA Adverse Event
Malfunction
·NIPRO CORPORATION *USD*·Product code MSF·November 5, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 7, 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