Data / Medical devices / Japan / Mizuho Corporation

Mizuho Corporation: FDA-registered device maker in BUNKYO-KU Tokyo, Japan, 11 510(k) clearances

Name: Mizuho Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mizuho Corporation is registered with the FDA (registration 3011547624) in BUNKYO-KU Tokyo, Japan. It lists 16 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 24, 2022. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Mizuho Corporation

FDA registration number: 3011547624
Address: 3-30-13 Hongo, BUNKYO-KU Tokyo, Japan, 1130033
Owner or operator: MIZUHO Corporation (9007414)
Roles: Exporter to the US
First device listed: December 19, 1994
Registered through: 2027
Brand names listed: 02-061-01 Dura Scissors, Str, 02-061-02 Dura Scissors, Cvd, 02-095-01 Kerrison Rongeur 150 x 2 mm, 35 deg, Upward, 02-095-02 Kerrison Rongeur 150 x 3 mm, 35 deg, Upward, 02-095-03 Kerrison Rongeur 150 x 4 mm, 35 deg, Upward, 02-095-04 Kerrison Rongeur 150 x 5 mm, 35 deg, Upward, 02-095-05 Kerrison Rongeur 180 x 3 mm, 35 deg, Upward, 02-095-06 Kerrison Rongeur 180 x 4 mm, 35 deg, Upward and more

Devices it lists

Device	Product code	Class	Role	Source
Applier, Aneurysm Clip	HCI	2	Exporter to the US	accessdata.fda.gov
Applier, Hemostatic Clip	HBT	1	Exporter to the US	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Exporter to the US	accessdata.fda.gov
Clip, Aneurysm	HCH	2	Exporter to the US	accessdata.fda.gov
Headrest, Neurosurgical	HBM	1	Exporter to the US	accessdata.fda.gov
Holder, Head, Neurosurgical (Skull Clamp)	HBL	2	Exporter to the US	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Exporter to the US	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Exporter to the US	accessdata.fda.gov
Punch, Surgical	LRY	1	Exporter to the US	accessdata.fda.gov
Rack, Clip	HBR	1	Exporter to the US	accessdata.fda.gov
Retractor, Self-Retaining, For Neurosurgery	GZT	2	Exporter to the US	accessdata.fda.gov
Rongeur, Nasal	KBB	1	Exporter to the US	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Exporter to the US	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 24, 2022	K221524	Sugita AVM Microclip Applier	HCI	Substantially Equivalent	Mizuho America, Inc.	accessdata.fda.gov
March 2, 2022	K211183	Sugita AVM Microclips	HCH	Substantially Equivalent	Mizuho America, Inc.	accessdata.fda.gov
June 4, 1999	K990202	SUGITA TITANIUM ANEURYSM CLIP	HCH	Substantially Equivalent	Mizuho America, Inc.	accessdata.fda.gov
February 5, 1997	K960037	SUGITA AVM MICROCLIP	HCH	Substantially Equivalent	Mizuho America, Inc.	accessdata.fda.gov
September 12, 1996	K955012	MIZUHO RADIOLUCENT HEAD FRAME	HBL	Substantially Equivalent	Mizuho America, Inc.	accessdata.fda.gov
July 3, 1990	K902517	NEUROSURGICAL HEADFRAME ACCESSORIES	GZT	Substantially Equivalent	Sims Surgical, Inc.	accessdata.fda.gov
June 6, 1988	K881912	SANO CLIP APPLIERS & REMOVERS	HCI	Substantially Equivalent	Downs Surgical , Ltd.	accessdata.fda.gov
June 6, 1988	K881911	NEW SIZES SUGITA CLIPS	HCI	Substantially Equivalent	Downs Surgical , Ltd.	accessdata.fda.gov
July 30, 1986	K862696	TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP	HBT	Substantially Equivalent	Downs Surgical , Ltd.	accessdata.fda.gov
May 9, 1986	K861630	NEUROSURGICAL INSTURMENTS (VARIOUS)	HAO	Substantially Equivalent	Downs Surgical , Ltd.	accessdata.fda.gov
September 28, 1982	K821772	SURGITA/MIZHO MICRONEUROSURGERY HEAD FR	HBL	Substantially Equivalent	Downs Surgical , Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 24, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.