7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
TISSUE FORCEPS, VARIOUS TYPES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Belimed Steam Sterilizer MST-H TOP 5000
FDA 510(k)
FDA Class 2
·General Hospital
CENTRIA PHENYTOIN RIA TEST SET
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 5, 2010
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 10, 2014
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 31, 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