Fukuda Denshi Co., Ltd.

FDA Regulatory Profile

Fukuda Denshi Co., Ltd. appears in FDA public data with 1 recall, 2 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0203-2018, Class II) was initiated on October 16, 2017. Its most recent 510(k) clearance was granted on April 8, 2011.

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