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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 2 of 11
DeviceModel / ReferenceRegistriesClassStatus
Tapered Suction Tube, One Piece, 9Fr, 14.5cm WL 07-960-09XL
FDA UDI
Class IActive
Spurling Rongeur, Oval 4x10mm, 16cm WL 02-202-09
FDA UDI
Class IActive
Arachnoid Knife 3mm, 45 Degrees Up Angle, Bayonet, 11cm WL 07-821-14MA
FDA UDI
Class IActive
Temp. Mini & Standard Clip Case 07-944-44T
FDA UDI
Class IActive
Sugita Aneurysm Complete Clip Case 07-944-44
FDA UDI
Class IActive
Rotatable Grasping Forceps, Straight Jaw, 15.5cm WL 07-829-32
FDA UDI
Class IActive
Trapezoidal Speculum, 45x12mm Jaw 07-927-02
FDA UDI
Class IActive
Microscissors Bayonet, Straight Jaw, Round Handle, Ultrafine Blades, 8.5cm WL 07-827-24
FDA UDI
Class IActive
Tenotomy Scissors, Straight Jaw, Ring Handle, Thin Blades, 11cm 99-600-33
FDA UDI
Class IUnknown
Tapered Suction Tube, 9Fr, 13.3cm WL 07-DAY-09XLSC
FDA UDI
Class IActive
Needle Holder, Straight Jaw, 8cm WL 07-828-17MA
FDA UDI
Class IActive
TII Customizable Clip Tray 10030MA
FDA UDI
Class IActive
Papavero Speculum, Titanium, 90x13mm Jaw 07-917-07MA
FDA UDI
Class IActive
Microscissors Bayonet, Straight Jaw, Flat Handle, Ultrafine Blades, 11cm WL 07-827-24F
FDA UDI
Class IActive
Duckbill Spatula Dissector, Up Angle, Bayonet, 11cm WL 02-034-07MA
FDA UDI
Class IActive
Rotatable Biopsy Forceps, 2mm Spoon, 15cm WL 07-829-12
FDA UDI
Class IActive
Microscissors Straight, Straight Jaw, Round Handle, 7.5mm WL 07-CVM-03
FDA UDI
Class IActive
Round Knife 2mm, 30 Degrees Reverse Down, Straight, 9cm WL 07-CVM-21
FDA UDI
Class IActive
Tissue Forceps, Bayonet, Blunt Tip, 9cm WL 02-082-41
FDA UDI
Class IActive
Rotatable Microscissors, Straight Jaw, Single Shaft Handle, 11.5cm WL 07-827-62
FDA UDI
Class IActive
Tapered Suction Tube, 12Fr, 11.3cm WL 07-DAY-12LSC
FDA UDI
Class IActive
Teardrop Probe, 2.5mm Tip, 45 Degrees Up, Bayonet, 15cm WL 07-820-26XL
FDA UDI
Class IActive
Microscissors Straight, Straight Jaw, Round Handle, 3cm WL 07-827-48
FDA UDI
Class IActive
Microscissors Bayonet, Curved Jaw, Flat Handle, Ultrafine Blades, 13cm WL 07-827-27F
FDA UDI
Class IActive
Rhoton #3 Dissector, 3mm Tip, 30 Degrees Down, Bayonet, 11cm WL 02-034-04MA
FDA UDI
Class IActive
Micro Tying Forceps, Curved Jaw, 15cm 07-866-02
FDA UDI
Class IActive
Radiolucent Head Frame Case 07-980-00R
FDA UDI
Class IActive
Endoscopic Microscissors, Curved Right Jaw, Pistol-Grip, 12cm WL 07-181-18MA
FDA UDI
Class IActive
Round Knife 2mm, 45 Degrees Down, Straight, 9cm WL 07-CVM-13
FDA UDI
Class IActive
Ring Curette, 3mm, 90 Degrees Up, Bayonet, 11cm WL 07-822-58MA
FDA UDI
Class IActive
Microscissors Bayonet, Curved Jaw, Flat Handle, Round Blades, 9cm WL 09-071-21F
FDA UDI
Class IActive
Microscissors Bayonet, Curved Jaw, Round Handle, Fine Blades, 6.5cm WL 07-827-02
FDA UDI
Class IActive
Ring Curette, 1.5mm, 45 Degrees Down, Bayonet, 11cm WL 07-822-65MA
FDA UDI
Class IActive
Tapered Suction Tube, One Piece, 8Fr, 11cm WL 07-960-08L
FDA UDI
Class IActive
Micro Tying Forceps, Curved Jaw, 21cm 07-866-06
FDA UDI
Class IActive
Rotatable Microscissors, Angled Jaw, 45 Degrees Lateral, Single Shaft Handle, 9. 07-827-65
FDA UDI
Class IActive
Tapered Suction Tube, 11Fr, 13.3cm WL 07-DAY-11XLSC
FDA UDI
Class IActive
Tapered Suction Tube, 10Fr, 6.8cm WL 07-DAY-10SSC
FDA UDI
Class IActive
Love-Gruenwald Rongeur, Oval 3x10mm, 16cm WL 02-202-08
FDA UDI
Class IActive
LawtonElite Microscissors Bayonet, Curved Right Jaw, 7.6cm WL 10204MA
FDA UDI
Class IActive
Tapered Suction Tube, 5Fr, 8.8cm WL 07-DAY-05MSC
FDA UDI
Class IActive
Microscissors Straight, Straight Jaw, Round Handle, Closed Bladess, 6cm WL 07-CVM-02
FDA UDI
Class IActive
Suction Tube, 8Fr, Atraumatic, 13.3cm WL 10052MA
FDA UDI
Class IActive
Round Knife 4mm, 45 Degrees Down, Straight, 9cm WL 07-CVM-15
FDA UDI
Class IActive
Tapered Suction Tube, 6Fr, Malleable, 13.3cm WL 10224MA
FDA UDI
Class IActive
Microscissors Straight, Straight Jaw, Round Handle, Irrigation, 3cm WL 07-827-49
FDA UDI
Class IActive
Ring Curette, 7mm, 45 Degrees Up, Bayonet, 12.5cm WL 07-822-27
FDA UDI
Class IActive
Tapered Suction Tube, 10Fr, 8.8cm WL 07-DAY-10MSC
FDA UDI
Class IActive
Ring Curette, Donut Style, 1.5mm, 90 Degrees Up, 15cm WL 10039MA
FDA UDI
Class IActive
Suction Tube, 10Fr, Atraumatic, 11.3cm WL 10049MA
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.