8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JR IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TISSUE SAMPLING NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 3, 2024
ACCU-CHEK ® COMPACT PLUS (GT)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·May 24, 2013
HOMECHOICE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 30, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011
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