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MIZUHO AMERICA, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
30057 Ahern Ave, Union City, CA, 94587
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
1000159388
DUNS Number
877624940

Catalogue (547)

Page 1 of 11
DeviceModel / ReferenceRegistriesClassStatus
Round Knife 4mm, 30 Degrees Reverse Down, Straight, 9cm WL 07-CVM-23
FDA UDI
Class IActive
Tapered Suction Tube, One Piece, 5Fr, 11cm WL 07-960-05L
FDA UDI
Class IActive
Kelly Keyhole Organization Tray 1 07-822-00MA
FDA UDI
Class IActive
Round Knife 2mm, 30 Degrees Reverse Down, Straight, 9cm WL 07-CVM-05
FDA UDI
Class IActive
Ring Curette, Donut Style, 1.5mm, 45 Degrees Up, 15cm WL 10035MA
FDA UDI
Class IActive
Teardrop Probe, 90 Degrees Up, Ball Tip, 10cm WL 10010MA
FDA UDI
Class IActive
Ring Curette, Donut Style, 5mm, Offset, 15cm WL 10199MA
FDA UDI
Class IActive
Micro Needle Holder, Straight Jaw, 20.5cm 07-862-05
FDA UDI
Class IActive
Round Knife 1mm, 45 Degrees Down, Straight, 9cm WL 07-CVM-12
FDA UDI
Class IActive
Micro Needle Holder, Curved Jaw, 18cm 07-862-04
FDA UDI
Class IActive
Kelly Endoscopic Endonasal Instruments Organization Tray 2 07-200-04MA
FDA UDI
Class IActive
Micro Jeweler Forceps #2, 12cm 07-863-02
FDA UDI
Class IActive
Teardrop Probe, 2.5mm Tip, 90 Degrees Up, Bayonet, 12.5cm WL 07-820-27
FDA UDI
Class IActive
Micro Dilator Forceps, Straight Jaw, 21cm 07-868-05
FDA UDI
Class IActive
Multi-hole atraumatic suction 9fr 99-400-21
FDA UDI
Class IUnknown
Tapered Suction Tube, 10Fr, 11.3cm WL 07-DAY-10LSC
FDA UDI
Class IActive
Kelly Keyhole Organization Tray 2 07-822-01MA
FDA UDI
Class IActive
Nasal Forceps, 45 Degrees Up, 12cm WL 07-181-14MA
FDA UDI
Class IActive
Mallet, 18cm 01-413-10
FDA UDI
Class IActive
Rotatable Microscissors, Angled Jaw, Single Shaft Handle, 15.5cm WL 07-829-46
FDA UDI
Class IActive
Cup Curette, 1.5x2mm, 45 Degrees Up, 10cm WL 10017MA
FDA UDI
Class IActive
Adson Tissue Forceps, 12cm 07-181-01
FDA UDI
Class IActive
Youssef Cranial Nerve Dissection Organization Tray 10000MA
FDA UDI
Class IActive
Charbel Dissector, 1mm Tip, 13.5cm WL 99-400-29
FDA UDI
Class IActive
Round Knife 2mm, 45 Degrees Up, Straight, 9cm WL 07-CVM-17
FDA UDI
Class IActive
Antrum Punch, Backward Cutting, Rotatable, 8x2.5mm Bite, 10cm WL 07-181-15MA
FDA UDI
Class IActive
Needle Holder, Curved Jaw, 2.5cm WL 07-828-06MA
FDA UDI
Class IActive
Needle Holder, Curved Jaw, 8cm WL 07-828-18MA
FDA UDI
Class IActive
Yasargil Tumor Forceps, Bayonet, 5mm Serrated Spoon, 9cm WL 02-082-45
FDA UDI
Class IActive
LawtonElite Microscissors Bayonet, Reposable, Curved Left Blades, 10cm WL (Box o 10295MA-3
FDA UDI
Class IActive
Single Shaft Bipolar Tray 10298MA
FDA UDI
Class IActive
Microscissors Straight, Curved Jaw, Round Handle, 8cm WL 07-828-15MA
FDA UDI
Class IActive
Ring Curette, Donut Style, 5mm, 90 Degrees Up, 15cm WL 10041MA
FDA UDI
Class IActive
Cup Curette, 2x2.5mm, 90 Degrees Up, 10cm WL 10016MA
FDA UDI
Class IActive
Micro Tying Forceps, Straight Jaw, 18cm 07-866-03
FDA UDI
Class IActive
Round Dissector, 2.0mm Tip, 30 Degrees Up, 10cm WL 10004MA
FDA UDI
Class IActive
Multi-Hole Suction Tube, 9Fr, Atraumatic, 13.5cm WL 07-961-09XL
FDA UDI
Class IActive
Papavero Speculum, 65x10mm Jaw 07-907-04
FDA UDI
Class IActive
Multi-Hole Suction Tube, 5Fr, Atraumatic, 13.5cm WL 07-961-05XL
FDA UDI
Class IActive
Papevero Speculum 70mm 99-200-17
FDA UDI
Class IUnknown
Ring Curette, Donut Style, 1.5mm, Straight, Malleable, 15cm WL 10031MA
FDA UDI
Class IActive
Microscissors Bayonet, Curved Jaw, Round Handle, Ultrafine Blades, 12.5cm WL 07-827-29
FDA UDI
Class IActive
Standard & Large Clip Case 07-944-44S
FDA UDI
Class IActive
Multi-Hole Suction Tube, 7Fr, Atraumatic, 11.5cm WL 07-961-07L
FDA UDI
Class IActive
Teardrop Suction Tube, 7Fr, Atraumatic, Angled Down, 10.5cm WL 07-962-07D
FDA UDI
Class IActive
Tapered Suction Tube, One Piece, 9Fr, 11cm WL 07-960-09L
FDA UDI
Class IActive
Rotatable Micro Needle Holder, Straight Jaw, 12cm WL 07-829-01
FDA UDI
Class IActive
Spatula Dissector, 2.4mm, Curved Down , Bayonet, 15cm WL 02-034-13XL
FDA UDI
Class IActive
Spatula Dissector, 2mm Tip, 30 Degrees Up, 15cm WL 10221MA
FDA UDI
Class IActive
Ring Curette, Donut Style, 3mm, 45 Degrees Lateral, 15cm WL 10216MA
FDA UDI
Class IActive

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FDA Recalls (4)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Sep 11, 2019Z-0567-2021—open, classified

Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

Sep 11, 2019Z-0566-2021—open, classified

Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

Oct 10, 2013Z-0377-2014—terminated

Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.

Oct 10, 2013Z-0378-2014—terminated

Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.