12 results
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19ms
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Sources: EU EUDAMED, US FDA
BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Jaeger
FDA UDI
Jaeger Medical GmbH·34250892907155·MicroGard IIC, bacterial/viral filter
Vyaire
FDA UDI
Jaeger Medical GmbH·34250892903041·MicroGard II, bacterial/viral filter
Jaeger
FDA UDI
Jaeger Medical GmbH·34250892900026·MicroGard II, bacterial/viral filter
Jaeger
FDA UDI
Jaeger Medical GmbH·34250892900040·MicroGard II, bacterial/viral filter
V. Mueller
FDA UDI
CAREFUSION 2200, INC·10885403156137·DIAMOND-LINE SCISSORS STRAIGHT METZENBAUM 3.5MM...
LIQUICORD
FDA 510(k)
FDA Unclassified
·Unknown
PRINCIPAL ANALYTE REFERENCE SERUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 24, 2014
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·November 8, 2010
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 27, 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