Akita Sumitomo Bakelite Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0388-2017Class IISB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product USeptember 9, 2016
Z-0389-2017Class IISB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. September 9, 2016