Home / Companies / Sedecal USA, Inc.

Sedecal USA, Inc.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1691-2016Class IISedecal SA Mobile Diagnost w DR x-ray systemMarch 23, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K042361DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 DSeptember 29, 2004
K012546OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEMNovember 2, 2001
K012663EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)August 31, 2001