Custom Assemblies Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-3059-2017Class IIVarious custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-RJune 15, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K993463INTRAVASCULAR ADMINISTRATION SETJanuary 4, 2000