FDA applicant

Freudenberg Medical, LLC

Jeffersonville, IN3 decisions2019–20240 recalls

FDA records 3 decisions for Freudenberg Medical, LLC (Jeffersonville, IN) from 2019 to 2024: 3 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DRA (Catheter, Steerable). Its devices cite 4 predicates, 0 of them its own earlier devices. 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2024

2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Freudenberg Medical, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Freudenberg Medical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Freudenberg”

FDA records each applicant name separately; these may or may not be the same firm.

Freudenberg Technology Innovation SE & Co. KG 1 Freudenberg Performance Materials LP 1 Freudenberg Medical Mis, Inc. 1

Freudenberg Medical, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Freudenberg”