Myelotec, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2779-2017Class IIMyelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working ChannMarch 2, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K122411J-SCOPE SYSTEMFebruary 11, 2013
K980734MYELOTEC VIDEO GUIDED CATHETERAugust 11, 1998
K960194MYELOTEC MYELOSCOPESeptember 4, 1996