510(k) Report

FDA applicant

Elastomade Accessories Sdn Bhd

Petaling Jaya, MY3 decisions1991–19950 recalls

FDA records 3 decisions for Elastomade Accessories Sdn Bhd (Petaling Jaya, MY) from 1991 to 1995: 3 510(k) clearances. All are in product code EIE (Dam, Rubber). 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, dental panel, where it files most

How often FDA has decided Elastomade Accessories Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Elastomade Accessories Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Elastomade Accessories Sdn Bhd’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