FDA applicant

D-R Medical Systems, Inc.

Northvale, NJ3 decisions1988–19890 recalls

FDA records 3 decisions for D-R Medical Systems, Inc. (Northvale, NJ) from 1988 to 1989: 3 510(k) clearances. All are in product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…). 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 D-R Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for D-R Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like D-R Medical Systems, Inc.’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

D-R Medical Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?