FDA applicant

Isramed, Inc.

Mchenry, IL3 decisions1981–19820 recalls

FDA records 3 decisions for Isramed, Inc. (Mchenry, IL) from 1981 to 1982: 3 510(k) clearances. Most are in product codes GDY (Gauze/Sponge, Internal, X-Ray Detectable) 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Isramed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Isramed, 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

Isramed, Inc.

Which product codes does it file in?

What has FDA decided for it lately?