510(k) Report

FDA applicant

Bd Medical Systems

Franklin Lakes, NJ1 decision2001–20010 recalls

FDA records 1 decision for Bd Medical Systems (Franklin Lakes, NJ) in 2001: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Bd Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bd Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bd Medical Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen1decision

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010188BD Eclipse Hypodermic NeedleBd Medical Systems · 20017cite it

What has FDA decided for it lately?

  • K010188BD Eclipse Hypodermic NeedleBd Medical Systems · 2001

The one decision as Bd Medical Systems →