510(k) Report

FDA applicant

Med-Dyne

Louisville, KY1 decision2008–20081 recall

FDA records 1 decision for Med-Dyne (Louisville, KY) in 2008: 1 510(k) clearance. All are in product code DSA (Cable, Transducer And Electrode, Patient…). 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, cardiovascular panel, where it files most

How often FDA has decided Med-Dyne’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2008high 1 (2019) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Med-Dyne by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision

What has FDA decided for it lately?

  • K080112Patient CableMed-Dyne · 20081 recall

The one decision as Med-Dyne →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080112Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24"…Aug 1, 2019Class II