7 results
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25ms
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Sources: EU EUDAMED, US FDA
ENDOSCOPIC INJECTION NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoreLink Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2014
DELTAPLUSH - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MICRUS ENDOVASCULAR, LLC·Product code HCG·November 6, 2012
STRYKEFLOW2 WITHOUT TIP (6BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GCX·August 27, 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