8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
UTERINE TENTACULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FORZA
FDA UDI
Orthofix US LLC·18257200077847·CUP CURETTE DOWN #00 - SERRATED
MIM on Linux
FDA 510(k)
FDA Class 2
·Radiology
AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 3, 2010
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·December 29, 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