Fukuda Denshi Co., Ltd.

Medical device manufacturer in Bunkyo-Ku, Tokyo, Japa.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K110920UF-760AGITX · Traditional 04/08/2011SE
K081919UF-870 AG Diagnostic Ultrasound SystemITX · Special 09/09/2008SE

Recalls

RecallProductInitiated
Z-0203-2018 Class IIFukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the…For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold… 10/16/2017Completed