8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MIDAS 100 HEMACOLOR STAIN #66030
FDA 510(k)
FDA Class 1
·Hematology
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788229820·Tranquil-L ALIF Trial 16x40x31, 6 deg
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
FDA 510(k)
FDA Class 1
·Ophthalmic
CRYOLOCK
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·October 23, 2012
GEMSTR 7 THPY ALT ST
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 19, 2014
HOMECHOICE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - LARGO·Product code FKX·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