Company ยท US
Mizuho America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2022. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2022 | K221524 | Sugita AVM Microclip Applier Mizuho America, Inc. | HCI |
| Mar 2, 2022 | K211183 | Sugita AVM Microclips Mizuho America, Inc. | HCH |
| Jun 4, 1999 | K990202 | SUGITA TITANIUM ANEURYSM CLIP Mizuho America, Inc. | HCH |
| Feb 5, 1997 | K960037 | SUGITA AVM MICROCLIP Mizuho America, Inc. | HCH |
| Sep 12, 1996 | K955012 | MIZUHO RADIOLUCENT HEAD FRAME Mizuho America, Inc. | HBL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2019 | Mizuho America, Inc. Microsurgical Operating Room Tables;7300BX (18-351-70). Open, Classified |
GDC | None listed |
| Sep 11, 2019 | Mizuho America, Inc. Microsurgical Operating Room Tables;7300B (18-350-70); Open, Classified |
GDC | None listed |
| Nov 22, 2013 | Mizuho America, Inc. Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58
Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designe Terminated |
HCH | K990202 |
| Nov 22, 2013 | Mizuho America, Inc. Mizuho Sugita Titanium Standard Aneurysm Clip II ,
Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use. Terminated |
HCH | K990202 |