FDA applicant

Ep Medical, Inc.

Budd Lake, NJ3 decisions1991–19940 recalls

FDA records 3 decisions for Ep Medical, Inc. (Budd Lake, NJ) from 1991 to 1994: 3 510(k) clearances. Most are in product codes DTA (Tester, Pacemaker Electrode Function) and KNX (Collector, Urine, (And Accessories) 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Ep Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Ep Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?