Fukuda Denshi Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0203-2018Class IIFukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda DenshOctober 16, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K110920UF-760AGApril 8, 2011
K081919UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEMSeptember 9, 2008