9 results
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19ms
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Sources: EU EUDAMED, US FDA
High speed air turbine handpiece
FDA 510(k)
FDA Class 1
·Dental
Resoundant Acoustic Driver System
FDA 510(k)
FDA Class 2
·Radiology
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
FDA 510(k)
FDA Class 2
·Cardiovascular
8010042-2008-00171
FDA Adverse Event
Malfunction
·Product code CBK·October 20, 2008
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 16, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·July 29, 2013
BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·March 26, 2024
BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·March 26, 2024
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