# Mizuho America, Inc.

- Location (FDA's records): Beverly, MA
- FDA decisions: 5 (1996–2022): 5 510(k) clearances
- Product codes: HCH (3), HBL (1), HCI (1)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aesculap, Inc.: 2 (https://510kreport.com/company/aesculap)
- Codman & Shurtleff, Inc.: 1 (https://510kreport.com/company/codman-shurtleff)
- Bausch & Lomb, Inc.: 1 (https://510kreport.com/company/bausch-lomb)
- Elekta Instruments, Inc.: 1 (https://510kreport.com/company/elekta-instruments)

## Firms that cite its devices most
- Dinkler Surgical Devices, Inc.: 1 (https://510kreport.com/company/dinkler-surgical-devices)
- Medicon EG: 1 (https://510kreport.com/company/medicon-eg)

## Its most-cited devices
- K955012: Mizuho Radiolucent Head Frame (1996), cited by 2
- K960037: Sugita Avm Microclip (1997), cited by 1

## Recent decisions
- K221524: Sugita AVM Microclip Applier (Jun 24, 2022)
- K211183: Sugita AVM Microclips (Mar 2, 2022)
- K990202: Sugita Titanium Aneurysm Clip (Jun 4, 1999)
- K960037: Sugita Avm Microclip (Feb 5, 1997)
- K955012: Mizuho Radiolucent Head Frame (Sep 12, 1996)

Source page: https://510kreport.com/company/mizuho-america