510(k) Report

FDA applicant

Cormed, Inc., Sub. C.R.Bard, Inc.

Medina, NY8 decisions1983–19861 recall

FDA records 8 decisions for Cormed, Inc., Sub. C.R.Bard, Inc. (Medina, NY) from 1983 to 1986: 8 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and LJT (Port & Catheter, Implanted, Subcutaneous…). 1 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 Cormed, Inc., Sub. C.R.Bard, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cormed, Inc., Sub. C.R.Bard, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cormed, Inc., Sub. C.R.Bard, Inc. 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?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2decisions
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2decisions
  • FRNPump, Infusion1decision
  • GAANeedle, Aspiration And Injection, Disposable1decision
  • FMINeedle, Hypodermic, Single Lumen1decision
  • DYBIntroducer, Catheter1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K823553Corcath H & B Vascular Access CatheterCormed, Inc., Sub. C.R.Bard, Inc. · 19831cites it
  • K863606Butterfly Non-Coring Needle SetCormed, Inc., Sub. C.R.Bard, Inc. · 19861cites it

What has FDA decided for it lately?

  • K863606Butterfly Non-Coring Needle SetCormed, Inc., Sub. C.R.Bard, Inc. · 19861 recall
  • K860432Percutaneous Introducer KitCormed, Inc., Sub. C.R.Bard, Inc. · 1986
  • K854019Port-GardCormed, Inc., Sub. C.R.Bard, Inc. · 1985
  • K850967Sterile Cormed MediportCormed, Inc., Sub. C.R.Bard, Inc. · 1985
  • K850674Cormed II Ambulatory Infusion PumpCormed, Inc., Sub. C.R.Bard, Inc. · 1985
  • K843083Cormed Huber Point NeedleCormed, Inc., Sub. C.R.Bard, Inc. · 1984
  • K833915Vascular Access Cath. Repair KitCormed, Inc., Sub. C.R.Bard, Inc. · 1984
  • K823553Corcath H & B Vascular Access CatheterCormed, Inc., Sub. C.R.Bard, Inc. · 1983

All 8 as Cormed, Inc., Sub. C.R.Bard, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K863606Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.Sep 23, 2003