7 results
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17ms
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Sources: EU EUDAMED, US FDA
OLIVECORONA SCISSORS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NG-Test CARBA 5
FDA 510(k)
FDA Class 2
·Microbiology
DRX-EVOLUTION, MODEL VX3733-SYS
FDA 510(k)
FDA Class 2
·Radiology
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 10, 2014
LIGACLIP CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 6, 2015
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·November 5, 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