7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TABLE, OPERATING, FIELD 6530-00-709-8155
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEDICA EASYQC HEMATOCRIT CONTROL
FDA 510(k)
FDA Class 2
·Hematology
INTEGRA INTERSPINOUS PROCESS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LZG·May 20, 2014
KOENIG TRIGLANGED RINGLOC + ACETABULAR COMPONENT W/LOCKRING 54MM LEFT SZ 24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·November 7, 2012
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURING FACILITY·Product code KDJ·August 31, 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