Myelotec, Inc.

FDA Regulatory Profile

Myelotec, Inc. appears in FDA public data with 1 recall, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2779-2017, Class II) was initiated on March 2, 2017. Its most recent 510(k) clearance was granted on February 11, 2013.

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