Mizuho USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Naturale Hcg Pregnancy Tes Ref K964002
Regimes: 510(k) Registry: 510(k)Hcg Midstream Pregnancy Test Ref K931997
Regimes: 510(k) Registry: 510(k)Multi-Use Electronic Pregnancy Test Ref K060825
Regimes: 510(k) Registry: 510(k)Proof Positive Electronic Pregnancy Test Ref K043231
Regimes: 510(k) Registry: 510(k)Quick Checker Hcg Pregnancy Test Ref K943859
Regimes: 510(k) Registry: 510(k)Absolute Hcg Pregnancy Test Ref K000844
Regimes: 510(k) Registry: 510(k)Hcg Midstream Pregnancy Test Ref K945568
Regimes: 510(k) Registry: 510(k)
FDA recalls
2006
- 17 Nov 2006 Z-0469-2007 Unclassified (pre-2012) Terminated False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
Frequently asked questions
How many devices does Mizuho USA, Inc. have in the registry?
The registry currently lists 7 devices for Mizuho USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mizuho USA, Inc.'s devices?
Among its 7 most recently registered devices, Mizuho USA, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Mizuho USA, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Mizuho USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mizuho USA, Inc.?
FDA recall records list 1 recall initiated by Mizuho USA, Inc., the most recent initiated on 17 Nov 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Mizuho USA, Inc. in the registry?
The most recently registered devices listed for Mizuho USA, Inc. include NATURALE HCG PREGNANCY TES, HCG MIDSTREAM PREGNANCY TEST, MULTI-USE ELECTRONIC PREGNANCY TEST and PROOF POSITIVE ELECTRONIC PREGNANCY TEST.