12 results
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22ms
·
Sources: EU EUDAMED, US FDA
VENES CUSTON RX
FDA 510(k)
FDA Class 1
·General Hospital
UniTip Catheter
FDA UDI
Unisensor AG·07640172972328·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972311·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972335·
CARESIDE LDH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VISIA ONCOLOGY
FDA 510(k)
FDA Class 2
·Radiology
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 9, 2014
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC.·Product code CBK·October 4, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 30, 2010
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 -
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 23, 2018
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