Vital Signs Colorado Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1556-2015Class IICareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in thMarch 13, 2015
Z-1557-2015Class IIIntroduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.March 13, 2015
Z-0812-2014Class IIVital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface betweeDecember 26, 2013
Z-0407-2013Class IIVital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperaturAugust 17, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K051559IMASK, MODELS 100, 200 AND 300July 8, 2005