Company
Mizuho OSI
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)
0recalls 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) |
|---|---|---|---|
| Jul 29, 2021 | Mizuho OSI HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 Open, Classified |
LXH | None listed |
| Feb 8, 2021 | Mizuho OSI Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations. Open, Classified |
GDC | None listed |
| Oct 14, 2019 | Mizuho OSI Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI
Refurbished Levo Arm Label: LEVO ARM REF 7887-050R
MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head supp Terminated |
JEA | None listed |
| Apr 19, 2017 | Mizuho OSI 216 Wilson Frame Pads, Model # 5319-37;
Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G.
General and Plastic Surgery: These pads are used as a component of the Wilson Frames, whic Terminated |
FWZ | None listed |
| Feb 9, 2016 | Mizuho OSI Mizuho OSI Trios, Table Base;
Voltage: 100-240V ~ 50/60 Hz
Amps: 5,0-5.0A;
Model 7803 and 7803AP
Orthopaedic:
Operating room tablebase - an electronically powered mobile operating table is created, d Terminated |
GDC | None listed |
| Feb 13, 2013 | Mizuho OSI Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar. Terminated |
JEA | None listed |