MEDLINE HYPODERMIC NEEDLES— 510(k) K062984

Clearance details

Applicant

Medline Industries, Inc.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2006-09-29

Decision date

2006-11-13

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Mundelein, IL, US

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

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• K222665 — Medline UNITE® Ankle Fusion Plating System2023-01-25
• K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe2022-12-09

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 →