EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO— 510(k) K091140
Substantially EquivalentVidacare Corporation
FDA 510(k) clearance K091140 for EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO, Substantially Equivalent on 2009-10-14. Applicant: Vidacare Corporation. Device class: 2.
Clearance details
- Applicant
- Vidacare Corporation
- Product code
- Code FMI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code FMI
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- K261829 — Profoject Dual-Safety Pen Needles
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More clearances from Vidacare Corporation
view allAdverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K091140
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091140.
Data sourced from openFDA. This site is unofficial and independent of the FDA.