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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 11 of 11
DeviceModel / ReferenceRegistriesClassStatus
Microscissors Straight, Curved Jaw, Round Handle, 15cm 07-827-21
FDA UDI
Class IActive
Microscissors Bayonet, Curved Jaw, Round Handle, Ultrafine Blades, 6.5cm WL 07-827-23
FDA UDI
Class IActive
Spatula Dissector, 1.8mm, Up, Bayonet, 12.5cm WL 02-034-14MA
FDA UDI
Class IActive
Round Dissector, 2.0mm Tip, 45 Degrees Up, 10cm WL 10005MA
FDA UDI
Class IActive
Tapered Suction Tube, 8Fr, Malleable, 11.3cm WL 10059MA
FDA UDI
Class IActive
Rotatable Microscissors, Angled Jaw, Single Shaft Handle, 12cm WL 07-829-45
FDA UDI
Class IActive
Teardrop Probe, 90 Degrees Up, Bayonet, 9cm WL 07-820-30MA
FDA UDI
Class IActive
Ring Curette, 3mm, 45 Degrees Down, Bayonet, 15cm WL 07-822-43XL
FDA UDI
Class IActive
Tissue Forceps, Bayonet, Sharp Tip, 9cm WL 02-082-40
FDA UDI
Class IActive
Teardrop Probe, 2.5mm Tip, Straight, Bayonet, 12.5cm WL 07-820-24
FDA UDI
Class IActive
Tapered Suction Tube, 11Fr, 6.8cm WL 07-DAY-11SSC
FDA UDI
Class IActive
Weil-Blakesley Rongeur, Oval 2.2x1.9mm, 12cm WL 07-181-25MA
FDA UDI
Class IActive
Tapered Suction Tube, 9Fr, 8.8cm WL 07-DAY-09MSC
FDA UDI
Class IActive
Needle Holder, Straight Jaw, 5cm WL 07-828-11MA
FDA UDI
Class IActive
Ring Curette, 5mm, 90 Degrees Up, Bayonet, 9cm WL 07-822-49MA
FDA UDI
Class IActive
Microscissors Bayonet, Straight Jaw, Flat Handle, Fine Blades, 15cm WL 07-827-07F
FDA UDI
Class IActive
Teardrop Suction Tube, 7Fr, Atraumatic, Angled Up, 10.5cm WL 07-962-07U
FDA UDI
Class IActive
Rotatable Biopsy Forceps, 45 Degrees Up, 2x5mm Spoon, 12cm WL 07-829-15
FDA UDI
Class IActive
Trapezoidal Speculum, 60x13mm Jaw, Up 07-927-04
FDA UDI
Class IActive
Ring Curette, 3mm, 45 Degrees Up, Bayonet, 9cm WL 07-822-54MA
FDA UDI
Class IActive
Rotatable Grasping Forceps, Angled Jaw, 11.5cm WL 07-829-33
FDA UDI
Class IActive
Ring Curette, 3mm, 90 Degrees Up, Bayonet, 12.5cm WL 07-822-33
FDA UDI
Class IActive
Ring Curette, Donut Style, 5mm, 45 Degrees Up, 15cm WL 10037MA
FDA UDI
Class IActive
Ring Curette, Donut Style, 3mm, Straight, Malleable, 15cm WL 10032MA
FDA UDI
Class IActive
Suction Tube Handle, Teardrop Control, 11cm TL 07-DAY-01SC
FDA UDI
Class IActive
Microscissors Straight, Angled Jaw, 60 Degrees Up, Round Handle, 6cm WL 07-827-50
FDA UDI
Class IActive
Round Knife 3mm, 45 Degrees Up, Straight, 9cm WL 07-CVM-18
FDA UDI
Class IActive
Evans Endonasal Set Tray 10293MA
FDA UDI
Class IActive
Tapered Suction Tube, 6Fr, Malleable, 11.3cm WL 10058MA
FDA UDI
Class IActive
Ring Curette, 5mm, 90 Degrees Up, Bayonet, 12.5cm WL 07-822-35
FDA UDI
Class IActive
Tapered Suction Tube, 8Fr, 8.8cm WL 07-DAY-08MSC
FDA UDI
Class IActive
Ring Curette, Donut Style, 7mm, 45 Degrees Up, 15cm WL 10038MA
FDA UDI
Class IActive
Duckbill Spatula Dissector, Down Angle, Bayonet, 9cm WL 02-034-06MA
FDA UDI
Class IActive
Tapered Suction Tube, 4Fr, 13.3cm WL 07-DAY-04XLSC
FDA UDI
Class IActive
Microscissors Bayonet, Straight Jaw, Flat Handle, Fine Blades, 13cm WL 07-827-05F
FDA UDI
Class IActive
Decker Rongeur, Round 2mm, 14cm WL 02-082-21
FDA UDI
Class IActive
Rotatable Microscissors, Angled Jaw, 45 Degrees Lateral, Single Shaft Handle, 11 07-827-66
FDA UDI
Class IActive
Tapered Suction Tube, 3Fr, 6.8cm WL 07-DAY-03SSC
FDA UDI
Class IActive
Microscissors Bayonet, Straight Jaw, Round Handle, Fine Blades, 6.5cm WL 07-827-01
FDA UDI
Class IActive
Microscissors Bayonet, Straight Jaw, Round Handle, Ultrafine Blades, 11cm WL 07-827-26
FDA UDI
Class IActive
Tapered Suction Tube, 10Fr, Malleable, 13.3cm WL 10226MA
FDA UDI
Class IActive
Rhoton #3 Dissector, 3mm Tip, 30 Degrees Down, Bayonet, 9cm WL 02-034-02MA
FDA UDI
Class IActive
Micro Tying Forceps, Straight Jaw, 15cm 07-866-01
FDA UDI
Class IActive
Tapered Suction Tube, 7Fr, 13.3cm WL 07-DAY-07XLSC
FDA UDI
Class IActive
Sugita AVM Microclip Applier K221524
FDA 510(k)
Class IIActive
Sugita Avm Microclip K960037
FDA 510(k)
Class IIActive
Sugita AVM Microclips K211183
FDA 510(k)
Class IIActive

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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.