13 results
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19ms
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Sources: EU EUDAMED, US FDA
FRS LITE FLUORIDE RELEASING SEALANT
FDA 510(k)
FDA Class 2
·Dental
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·October 26, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·October 26, 2017
MODIFICATION TO: TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BS 66, UNIVERSAL BUCKY STAND
FDA 510(k)
FDA Class 2
·Radiology
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·March 6, 2019
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·August 24, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 10, 2016
FLEXIBLE SILICONE DRILL DRIVER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HTW·September 22, 2022
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 3, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·October 28, 2010
MMC HIP GENERIC
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·December 21, 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