510(k) Report

FDA applicant

Futumeds Sdn Bhd

Puchong, MY1 decision2005–20050 recalls

FDA records 1 decision for Futumeds Sdn Bhd (Puchong, MY) in 2005: 1 510(k) clearance. All are in product code MDM (Instrument, Manual, Surgical, General 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Futumeds Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MDMInstrument, Manual, Surgical, General Use1decision

What has FDA decided for it lately?

  • K050575Futumeds NO Patient Contact Safety Lancet with Pals SystemFutumeds Sdn Bhd · 2005

The one decision as Futumeds Sdn Bhd →