510(k) Report

FDA applicant

Researched, Novel Medical Devices (Rn/Md)

Sherman Oaks, CA3 decisions1993–19950 recalls

FDA records 3 decisions for Researched, Novel Medical Devices (Rn/Md) (Sherman Oaks, CA) from 1993 to 1995: 3 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and EYZ (System, Urine Drainage, Closed, For…). 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 Researched, Novel Medical Devices (Rn/Md)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Researched, Novel Medical Devices (Rn/Md) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Researched, Novel Medical Devices (Rn/Md) 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 Lumen2decisions
  • EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile1decision

What has FDA decided for it lately?

  • K944680Split Top Wing Needle Cap with Optional Tubing Anchors (and Appropriate Recap DeviceResearched, Novel Medical Devices (Rn/Md) · 1995
  • K942753One Step Specimen Collector/Transport ContainerResearched, Novel Medical Devices (Rn/Md) · 1994
  • K925234Bedside CaddyResearched, Novel Medical Devices (Rn/Md) · 1993

All 3 as Researched, Novel Medical Devices (Rn/Md) →