9 results
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25ms
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Sources: EU EUDAMED, US FDA
VARIOUS TYPES OF TONSILS HEMOSTATS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M75268222630·CUSTOM SURGICAL KIT - VEIN PACK
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M7526822263·CUSTOM SURGICAL KIT - VEIN PACK
14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
FDA 510(k)
FDA Class 2
·General Hospital
Arthrex Self Punching SwiveLock Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 20, 2014
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·November 7, 2012
ENDOPATH** XCEL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 1, 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