HUMERAL HEAD, MANUAL DRIVER— 510(k) K062422

Clearance details

Applicant

Vidacare Corporation

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2006-08-18

Decision date

2006-11-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

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• K260739 — Profoject Pen Needles (Model A; Model B)2026-07-15

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• K091140 — EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO2009-10-14

Death

28

Injury

1,517

Malfunction

23,981

Other

18

Total

25,544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →