8 results
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26ms
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Sources: EU EUDAMED, US FDA
GAS STERILIZATION EQUIPMENT
FDA 510(k)
FDA Class 2
·General Hospital
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
FDA 510(k)
FDA Class 2
·Hematology
ADMIRA SEAL
FDA 510(k)
FDA Class 2
·Dental
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·May 20, 2014
PDS LL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code NEW·November 6, 2012
SEMI ELECTRIC FOOT SPRING 9153638202
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·June 5, 2015
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 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