217 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 6, 2018
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·April 11, 2018
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
FDA Enforcement
Class II
·Terminated·BBI SOLUTIONS OEM LTD·November 2, 2016
GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·August 29, 2008
OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·April 15, 2008
GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·August 12, 2008
GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·July 2, 2008
OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·April 15, 2008
GE OEC 9900 Elite Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·August 12, 2008
InstaTrak 3500 Navigation and Visualization System
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code LLZ·December 13, 2004
GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·December 14, 2007
FluroTrak 9800 Plus Navigation and Visualization System
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·December 13, 2004
ENTrak Plus Navigation and Visualization System
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code LLZ·December 13, 2004
InstaTrak 3000 Navigation and Visualization System
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code LLZ·December 13, 2004
ENTrak Navigation and Visualization System
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code LLZ·December 13, 2004
GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·August 29, 2008
InstaTrak 3500 Plus Navigation and Visualization System
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code LLZ·December 13, 2004
Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code KKX·December 20, 2007
OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·May 24, 2007
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·January 18, 2017