FDA applicant

R-Med, Inc.

Oregon, OH9 decisions1994–20000 recalls

FDA records 9 decisions for R-Med, Inc. (Oregon, OH) from 1994 to 2000: 9 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and GCJ (Laparoscope, General & Plastic Surgery). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for R-Med, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like R-Med, 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

R-Med, Inc.

Which product codes does it file in?

What has FDA decided for it lately?