510(k) Report

FDA applicant

Bernard J. Cooney, P.A.

Chevy Chase, MD1 decision1990–19900 recalls

FDA records 1 decision for Bernard J. Cooney, P.A. (Chevy Chase, MD) in 1990: 1 510(k) clearance. All are in product code FKO (Catheter, Peritoneal Dialysis, Single Use). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Bernard J. Cooney, P.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bernard J. Cooney, P.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bernard J. Cooney, P.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Bernard”

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