10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARDIAC SECTOR PROBE 3.5. MHZ
FDA 510(k)
FDA Class 2
·Cardiovascular
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148501450·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117513·Distal Reamer (Hudson)
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192633·Distal Reamer (Hudson)
MD322C8 31.5 Diagnostic Imaging LCD Monitor
FDA 510(k)
FDA Class 2
·Radiology
CELLTRACKA ANALYZER II
FDA 510(k)
FDA Class 2
·Immunology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
APEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·November 29, 2012
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·September 21, 2010
CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
FDA Enforcement
Class II
·Terminated·Veridex, LLC·March 19, 2014