9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLSEN #770 DISPOSABLE HOLSTER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127029349·Bipolar Head Trial, Size 58mm
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
FDA 510(k)
FDA Class 2
·Cardiovascular
NON-EUGENOL TEMPORARY CEMENT
FDA 510(k)
FDA Class 1
·Dental
LIERTY CYCLER
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·May 9, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 2, 2012
CONICAL ABUTMENT GOLD STANDARD ZR TM 5MM(D) X 3MM(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