9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XOMED THERMAL MYRINGOTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127029332·Bipolar Head Trial, Size 57mm
MINI MAXLOCK EXTREME PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TEMPORARY CROWN AND BRIDGE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 2, 2012
CONICAL ABUTMENT GOLD STANDARD ZR TM 4.1MM (D) X 2MM (H)
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·July 25, 2016
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