FDA applicant

Unomedical Sdn Bhd

West Malaysia, MY9 decisions1995–19980 recalls

FDA records 9 decisions for Unomedical Sdn Bhd (West Malaysia, MY) from 1995 to 1998: 9 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and EZL (Catheter, Retention Type, Balloon). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Unomedical Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Unomedical”

FDA records each applicant name separately; these may or may not be the same firm.

Unomedical A/S 13 Unomedical Devices S.A DE C.V. 1 Unomedical A/S Infusion Devices 1

Unomedical Sdn Bhd

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Unomedical”