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Sources: EU EUDAMED, US FDA
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MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
FDA Recall
Terminated
·MedtestDx, Inc.·Product code JJY·May 15, 2015
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).
FDA Recall
Terminated
·Medtest Holdings, Inc.·Product code JJY·October 23, 2014
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011
Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)
FDA Recall
Terminated
·Natus Medical Inc·Product code ETY·June 27, 2005
A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment.
FDA Recall
Terminated
·A-Dec Inc·Product code KLC·April 1, 2009
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