Company
Mizuho Orthopedic Systems Inc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2012 | Mizuho Orthopedic Systems Inc Coupler System II
Mizuho Orthopedic Systems, Inc.
Union City, CA 94587
The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jac Terminated |
FWZ | None listed |
| Oct 27, 2011 | Mizuho Orthopedic Systems Inc Mizuho OSI Modular Table System;
Product Usage: For use in orthopaedic surgery to provide support to a patient. Terminated |
JEA | K910736 |
| Jan 20, 2011 | Mizuho Orthopedic Systems Inc Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA. Terminated |
JEA | None listed |
| Dec 13, 2007 | Mizuho Orthopedic Systems Inc OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included) Terminated |
LHN | None listed |
| Dec 13, 2007 | Mizuho Orthopedic Systems Inc OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic Surgery Table-- Stand alone single-pedestal AC power or battery operated table, Orthopedic Systems, Inc., Union City, CA Terminated |
JEA | None listed |
| Dec 13, 2007 | Mizuho Orthopedic Systems Inc OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Orthopedic Systems, Inc., Union City, CA Terminated |
LHN | None listed |