Mizuho America, Inc.
30057 Ahern Ave, Union City, CA, US
Registered product codes
13 product codes
Recent MDR events
15 on file
- HANA ORTHOPEDIC SURGERY TABLEDec 1, 2021MalfunctionMW5105726
- MCELVEEN-HITSELBERGER NEURAL DISSECTOR KNIFEJun 23, 2020MalfunctionMW5095168
- UNKNOWNFeb 20, 2018Malfunction7281950
- OSI FLAT TOP BEDFeb 15, 2017Malfunction6331514
- TABLE, SURGICALOct 7, 2015Malfunction5131066
- MIZUHO CARBON FIBER HEAD PINJun 26, 2013Other1223656-2013-00001
- *Nov 7, 2012Injury2861210
- SUGITAFeb 7, 20122466843
- SUGITA HEAD PINJul 28, 2011Malfunction1223656-2011-00002
- NONEApr 14, 2011Injury2143053
Recalls
4 on file
- TerminatedNov 22, 2013
Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
View FDA record ↗ - TerminatedNov 22, 2013
Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
View FDA record ↗ - Open, ClassifiedUnknown
Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.
View FDA record ↗ - Open, ClassifiedUnknown
Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.
View FDA record ↗
Compliance history
Matched by FEI 1000159388.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.