Mizuho America, Inc.

FDA Regulatory Profile

Mizuho America, Inc. appears in FDA public data with 4 recalls, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0566-2021, Class II) was initiated on September 11, 2019. Its most recent 510(k) clearance was granted on June 24, 2022.

Summary

Total Recalls
4
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0566-2021Class IIMicrosurgical Operating Room Tables;7300B (18-350-70);September 11, 2019
Z-0567-2021Class IIMicrosurgical Operating Room Tables;7300BX (18-351-70).September 11, 2019
Z-0377-2014Class IIMizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical sOctober 10, 2013
Z-0378-2014Class IIMizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanOctober 10, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K221524Sugita AVM Microclip ApplierJune 24, 2022
K211183Sugita AVM MicroclipsMarch 2, 2022
K990202SUGITA TITANIUM ANEURYSM CLIPJune 4, 1999
K960037SUGITA AVM MICROCLIPFebruary 5, 1997
K955012MIZUHO RADIOLUCENT HEAD FRAMESeptember 12, 1996