Mobius Medical Systems, LP

FDA Regulatory Profile

Mobius Medical Systems, LP appears in FDA public data with 1 recall, 3 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2100-2017, Class II) was initiated on February 23, 2015. Its most recent 510(k) clearance was granted on April 29, 2016.

Summary

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

Recent Recalls

NumberClassProductDate
Z-2100-2017Class IIMobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verifFebruary 23, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K153014Mobius3DApril 29, 2016
K141230DOSELAB PROAugust 27, 2014
K140660MOBIUS3DJune 24, 2014