9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MULTILUMEN INTRAVENOUS INFUSION CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRIHA+
FDA UDI
TEKNIMED·03760177041486·
Masel
FDA UDI
Ortho Organizers, Inc.·00190707034139·.020 Lower Stainless Steel Golden International...
NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS
FDA 510(k)
FDA Class 1
·General Hospital
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
FDA 510(k)
FDA Class 2
·Orthopedic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 16, 2014
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 6, 2012
OLYMPUS OES CYSTONEPHROFIBERSCOPE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAJ·August 26, 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