9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dymaxeon Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
ZURA TEE SYSTEM WITH CLARITEE PROBE
FDA 510(k)
FDA Class 2
·Radiology
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 7, 2017
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 14, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 30, 2011
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
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